http://www.novonordisk-jobs.com/feeds/Regulatory-Affairs-jobs/ Custom RSS Feed for Regulatory-Affairs-jobs Sun, 26 May 2013 06:21:37 GMT en-us /sites/novonordisk/images/Novo_Banner.gif http://www.novonordisk-jobs.com/feeds/Regulatory-Affairs-jobs/ 720
- Student and Internships
- Denmark - Søborg

At Novo Nordisk, we share a passion for changing patients’ lives, and we are always looking for talented individuals who want to join us in this effort. Our internships provide exciting learning opportunities for students who bring new ways of thinking to our company.

About the department
Regulatory Affairs Strategic Management Support is a staff function within Novo Nordisk Research & Development. Working in Regulatory Affairs Strategic Management Support means navigating in a fast-paced global environment where no two days are alike. Tight deadlines, cross-organisational collaboration, project management and the challenges of communicating with stakeholders in 70+ countries is part of our busy workday.

The job
In Regulatory Affairs Strategic Management Support you will be working with improvement projects (LEAN) and Quality Management tasks. Focus will be on standardising internal processes and establishing transparency across functions. Examples of tasks could be the mapping of internal processes, providing Regulatory Affairs management with data on progress of projects and activities, improving communication with internal stakeholders regarding LEAN and Quality Management, ad hoc analytical and administrative tasks.

Qualifications
You are in your first or second year of your Master programme within business, technical, or natural science studies. You are driven by a wish to do things smarter and to optimise work processes. You are detail oriented, a good planner and a proactive data driven problem-solver. You are a skilled communicator who is comfortable speaking and writing in English. As a person, you thrive in busy environments and bring a can-do spirit and a healthy sense of humour to your work – even when the pressure is on. You are a strong team player, but you also enjoy working independently and finding new solutions to the challenges you meet. You are expected to make an impact and to ask questions and challenge the status quo if that’s what it takes.

Practicalities

Qualification: Students in their first or second year of their master programme.

Period: The internship position is a full-time position for 4-6 months.

Start date: 1 September 2013.

Contact
For further information, please contact Marina Stokholm Bryld +45 3075 7338 or Lene Thrane on +45 3079 9510.

Deadline
10 June 2013.]]>Wed, 01 May 2013 00:00:00 GMThttp://www.novonordisk-jobs.com/job/S%C3%B8borg%2C-Denmark-LEAN-and-Quality-Internship-in-Regulatory-Affairs/2577017/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/S%C3%B8borg%2C-Denmark-LEAN-and-Quality-Internship-in-Regulatory-Affairs/2577017/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS
- Student and Internships
- Denmark - Søborg

At Novo Nordisk, we share a passion for changing patients’ lives, and we are always looking for talented individuals who want to join us in this effort. Our internships provide exciting learning opportunities for students who bring new ways of thinking to our company.

About the department
Regulatory Affairs is responsible for global strategies to obtain and maintain market authorisations worldwide for all Novo Nordisk's new products and for life cycle management activities such as new medical indications, new or changed production methods, or new facilities. Regulatory Affairs also carries responsibility for labelling of Novo Nordisk products. You get the opportunity to join an international, high performing Regulatory Academy team in Søborg, Denmark, responsible for providing contemporary regulatory training and competence development opportunities internally in Novo Nordisk.

The job
Regulatory Academy develops and offer training in close collaboration with key internal stakeholders in Regulatory Affairs. You will assist the training specialists in day-to-day business processes and tasks. You will be involved in updating the strategy for the internal training in Regulatory Affairs, and assist with analysing our current training management set-up.

Qualifications
We are looking for an intern who is passionate about training and competency development. You are currently studying on your master’s degree in training, communication or other relevant field. We expect candidates to be service minded, thrive in a busy environment and bring a can-do attitude. Fluency in both oral and written English; ability to manage a large volume of projects (with supervision); sound personal judgment; and excellent interpersonal skills are required.

Finally, you must have strong work ethic and willingness to take responsibility for your own learning.

At Novo Nordisk, decisions and actions are based on their impact on society, the environment and on their potential to generate a profit. That makes for a responsible culture with a healthy and engaging working environment.

Practicalities

Qualification: Students in their first or second year of their master studies.

Period: The internship position is a full-time position for 6 months.

Start date: 1 September 2013

Contact
For further information, please contact Lena Munk on +45 3079 6098.

Deadline
10 June 2013.]]>Thu, 02 May 2013 00:00:00 GMThttp://www.novonordisk-jobs.com/job/S%C3%B8borg%2C-Denmark-Internship-in-Regulatory-Academy/2579455/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/S%C3%B8borg%2C-Denmark-Internship-in-Regulatory-Academy/2579455/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS
- Student and Internships
- Denmark - Søborg

At Novo Nordisk, we share a passion for changing patients’ lives, and we are always looking for talented individuals who want to join us in this effort. Our internships provide exciting learning opportunities for students who bring new ways of thinking to our company.

About the department
Strategic Management Support is a staff function within Regulatory Affairs in Novo Nordisk Research & Development. Working in Regulatory Affairs Strategic Management Support means navigating in a fast-paced global environment where no two days are alike. Tight deadlines, cross-organisational collaboration, project management and the challenges of communicating with stakeholders in 70+ countries is part of our busy workday.

The job
In Regulatory Affairs Strategic Management Support you will be working with a wide range of internal communication tasks incl. developing our intranet and other internal communication platforms. Furthermore, you will engage in organising events, providing communication advice and support to our organisation, writing news stories for our intranet, analysing our stakeholder relations and other day to day staff function tasks.

Qualifications
You are in your first or second year of your Master programme within Communications or IT. You have solid IT skills and you are eager to explore new ways of engaging employees in internal business communication and knowledge sharing, e.g. through social media. You are organised, a good planner and a proactive problem-solver, and you’re a skilled communicator who is comfortable speaking and writing in English. As a person, you thrive in busy environments and bring a can-do spirit and a healthy sense of humour to your work – even when the pressure is on. You’re a strong team player, but you also enjoy working independently and finding new solutions to the challenges you meet. You are expected to make an impact and to ask questions and challenge the status quo if that’s what it takes.

Practicalities

Qualification: Students in their first or second year of their master programme.

Period: The internship position is a full-time position for 4-6 months.

Start date: 1 September 2013.

Contact
For further information, please contact Jakob Wolter +45 3079 7759 or Jakob I. Jensen on +45 3079 3815.

Deadline
10 June 2013.]]>Wed, 01 May 2013 00:00:00 GMThttp://www.novonordisk-jobs.com/job/S%C3%B8borg%2C-Denmark-Communication-Internship-in-Regulatory-Affairs%2C-Novo-Nordisk/2577016/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/S%C3%B8borg%2C-Denmark-Communication-Internship-in-Regulatory-Affairs%2C-Novo-Nordisk/2577016/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Title Sr. Associate/Specialist, Reg Affairs Operations-Submissions Publisher
Job Category Regulatory Affairs
Job Description PURPOSE:

The Regulatory Operations Senior Associate/Specialist will support the global extent of e-submissions and use of Insight Publisher and/or Novodocs for regulatory submissions in Novo Nordisk and will identify, analyze and develop technical solutions that improve Regulatory Affairs (RA) business processes, using available desktop technologies. Additionally, he/she will be responsible for ensuring accurate, consistent and timely submission planning and tracking data entry for Insight Manager.

RELATIONSHIPS:

The Regulatory Operations Senior Associate/Specialist will report to a Manager of Regulatory Operations & Innovations and will interact with the Therapeutic Areas (TA), SMART, Promotional Review, Product Safety and ROI.

ESSENTIAL FUNCTIONS:
? Responsible for the management, publishing and submission of eCTD submissions, including major filings
?Will help the Manager of Regulatory Operations manage tracking, coordinating, publishing, and submitting of all product submissions.
?Will also be required to update epub information as needed and timely archive submissions following internal procedures.

?Processes electronic files incorporating bookmarks, links and other formatting requirements and transmits these for filings and related regulatory notifications in accordance with established timeframes.

E-SUBMISSIONS PLANNING, TRACKING AND REPORTING AUTOMATION:

Primarily responsible for ensuring accurate, consistent and timely data entry for the Insight Manager application, including Record of Contact (ROC) entries and commitment tracking activities. The Regulatory Operations Senior Associate will configure Insight reports supporting RA customers’ needs. Additionally, the Regulatory Operations Senior Associate will develop or configure Crystal Reports solutions for Insight-related reports (submission planning and tracking, metrics, and portfolio and QMR data reporting). Finally, using InfoView and Sharepoint, he/she will automate distribution and delivery of reports to the end user.

OFFICE AUTOMATION SOLUTIONS FOR RA:

Working with the RA business areas, the Regulatory Operations Senior Associate/Specialist will identify, analyze, develop, pilot, and implement technology solutions for improving efficiency, quality, timeliness and cost. Solutions will be developed on a variety of available desktop software suites. The Regulatory Operations Senior Associate will also develop, manage, and grow the new Globeshare platform for Intranet content and teamsite solutions. Responsible for developing solutions that are both technical documentation as well as appropriate training materials.

SUPER USER SUPPORT AND TRAINING FOR KEY DEPARTMENTAL APPLICATIONS:

The Regulatory Operations Senior Associate/Specialist will promote and champion the use of existing and future technology platforms to quickly address evolving business needs.

The Regulatory Operations Senior Associate/Specialist will serve as first line support for key RA applications such as novoDOCS, epub (Insight), Globeshare, and InfoPath. Additionally, as SuperUser will help deliver and support rollout training activities and develop RA-specific training documentation.

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS

Bachelor's Degree or equivalent, with a minimum of 2 -4 years (higher for Specialist level) relevant regulatory experience.
IT competency is a plus especially in MS Office, InfoPath, Sharepoint
• knowledge of eCTD publishing
• Understanding of the eCTD structure as well as FDA and ICH specifications for eCTD submissions.

• Previous hands on experience with the eCTD processes behind the compilation of INDs/NDAs/Amend/Supplements
Department CMR - OPERATIONS & ARCHIVE
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Bachelor's Degree or equivalent experience]]>Fri, 17 May 2013 02:59:00 GMThttp://www.novonordisk-jobs.com/job/Princeton-Sr_-Associate-Specialist%2C-Regulatory-Affairs-Operations-Job-NJ-08540/2366236/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/Princeton-Sr_-Associate-Specialist%2C-Regulatory-Affairs-Operations-Job-NJ-08540/2366236/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Title Sr. Manager/Associate Director,Regulatory Affairs - Promotional Review
Job Description PURPOSE:

Manage the Regulatory review of Promotions and Advertisements for company marketed products.

RELATIONSHIPS:

Reports to the Director, Promotional Review. Works with other personnel in Marketing ,Marketing Operations, Regulatory, Medical Affairs, Sales, and Legal Departments in support of initiatives and Promotional Review Board (PRB) process and review of promotional materials. External relationships include interaction with FDA personnel regarding promotional issues. Develop and maintain positive rapport and working relationships within and across departments, including Marketing, in relation to promotional issues. Manages assigned junior personnel as direct reports. Attend FDA’s meetings and contribute to negotiations with FDA as necessary.

ESSENTIAL FUNCTIONS:

FDA COMPLIANCE:

Assure full regulatory compliance of all promotions with approved labeling.

Handle other duties and/or special projects as assigned by the Director/VP, Regulatory Affairs.

Maintain up-to-date knowledge of laws, regulations and policies enforced by the Federal and State governments as they relate to advertising and promotion of pharmaceuticals and devices. Advise appropriate departments within the company (NNI and NNAS) of these requirements. Assist the Director in establishing procedures to assure compliance with these requirements.

Provide training in FDA regulations for advertising and promotion to employees and agents of Novo Nordisk.

Review of draft and final advertising/promotional materials for marketed products, as assigned.
Coordinate and supervise the development of regulatory strategies for investigational, new or modified pharmaceutical products.
Approve specified regulatory submissions

PRB PROCESS:

Assist the Director in development and implementation of strategy to maintain efficient and compliant PRB process.

Builds a strong relationship with internal customers; including Marketing, Marketing Operations, Legal and Medical.

Builds a strong relationship with the FDA

Other duties as deemed appropriate by Director, PRB.

Provide regulatory review of draft promotional materials (pre-PRB).

Regulatory PRB reviewer.

Support development of launch materials/new claims by collaborating with Marketing, Medical and Legal. Prepare FDA submissions of draft introductory promotional materials.

SUBMISSIONS:

Assure company compliance with FDA and FTC requirements and strategy.

Ensure timely and accurate submission of promotional materials to FDA in Form 2253.

Oversee preparation and submission of draft introductory materials to FDA for comment.

PHYSICAL REQUIREMENTS:

Some travel required.

DEVELOPMENT OF PEOPLE:

Ensure that reporting personnel have 3P forms, which have annual goals and measurements, are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities. Understand their level of accountability for results and the measurement process.

Ensure that the IDP forms (reporting personnel and own) include completed Learning and Aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility.

Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way of Management.

Review subordinates 3P and IDP’s.

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS

A Bachelors Life Science degree required; advanced degree preferred.

A minimum of eight (8) years pharmaceutical industry experience, including direct FDA Regulatory Affairs interaction (submissions and negotiations).

A minimum of two (2) years Regulatory Promotional Review experience required.

Detail & deadline oriented; well organized.

Excellent verbal & written communication skills.

Good interpersonal skills; ability to interact with staff on all levels.

Works independently with minimal supervision.
Department CMR - PROMOTIONAL REVIEW
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Bachelor's Degree Required
Percent Travel 0 - 10%]]>Wed, 22 May 2013 02:59:00 GMThttp://www.novonordisk-jobs.com/job/Princeton-Sr_-Manager%2C-Regulatory-Affairs-Promotional-Review-Job-NJ-08540/2224770/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/Princeton-Sr_-Manager%2C-Regulatory-Affairs-Promotional-Review-Job-NJ-08540/2224770/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Title Sr. Attorney
Job Category Legal
Job Description PURPOSE:
Serve as legal counsel to global healthcare company with a focus on a broad range of legal, regulatory and compliance issues, including FDA regulations, False Claims Act, Anti-Kickback Statute, OIG guidance, and the PhRMA Code.

RELATIONSHIPS:
Responsible for providing contracting, regulatory and general legal support to the commercial organization. Includes daily interaction with the U.S. based brand team(s), marketing departments, medical affairs and regulatory affairs departments, and interaction with headquarters and other affiliates as required. May interact with government agencies, law firms, trade organizations and other external agencies. Reports to Corporate Counsel.

ESSENTIAL FUNCTIONS:
• Serve as lead counsel for one or more pharmaceutical brand(s), and includes participation in multidisciplinary committee in review of marketing materials
• Draft, review and negotiate commercial contracts, 3rd party vendor agreements, service agreements, consulting agreements and other corporate agreements
• Proactively prevent or minimize legal risk to the company, and help drive legal strategy to align and achieve business strategic goals
• Serve as a business partner in support of key customer group(s) with minimal oversight and guidance from managing attorney
• Keeps informed of new laws, regulations, and industry trends affecting the company, and assists with development of policies and training as needed

PHYSICAL REQUIREMENTS:
Occasional travel required (0-20%)

DEVELOPMENT OF PEOPLE:
Not Applicable

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
• A J.D. with 6-8 years relevant industry or law firm experience. In-house experience preferred, but not required
• A State Bar admission required
• Experience within the healthcare/pharmaceutical industry
• Strong problem-solving and decision making skills with demonstrated ability to think creatively and devise solutions to challenging problems
• Exceptional written and verbal communications skills – able to effectively collaborate and communicate with stakeholders throughout the company
• Manage workload effectively, set priorities and deliver results on agreed upon timelines
Department LPQ - LEGAL/GOVT & QUALITY AFFAIRS (1b)
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Juris Doctorate Required
Percent Travel 10 - 20%]]>Fri, 24 May 2013 03:00:00 GMThttp://www.novonordisk-jobs.com/job/Princeton-Sr_-Attorney-Job-NJ-08540/2567597/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/Princeton-Sr_-Attorney-Job-NJ-08540/2567597/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS
- Quality
- Denmark - Bagsværd

We are looking for a Regulatory Compliance Professional to join the department Safety Operations (SO) Quality & Training from 1st of June 2013.

About the department
The SO Quality & Training department belongs to Safety Operations, one of the functional areas in Global Safety. Global Safety is responsible for the global handling and reporting of adverse events to authorities, and the surveillance of the safety and quality of Novo Nordisk clinical development and marketed products.

SO Quality & Training consists of highly dedicated and motivated people with different educational backgrounds and different job tasks within quality. Focus on quality and compliance with worldwide regulations, guidelines and standard operating procedures are paramount for the department.

The job
As a Regulatory Compliance Professional in Safety Operations you will be working in an engaging and fast-paced environment reflecting the increasing demands from regulatory authorities. You will be working independently but also in collaboration with colleagues globally to identify, interpret and communicate new regulatory requirements within the safety and device area. You will be part of ensuring coherence between requirements and the internal operating procedures and guidelines. You understand the importance of structured working methods and thorough documentation.

Moreover, you will be a key knowledge person within, and hold an advisory function for, contracts with internal and external parties and make sure that these contracts do not in any way compromise Novo Nordisk compliance to applicable legislation, guidelines and internal standards for pharmacovigilance and device vigilance. You must be able to make informed decisions regarding contracts in an environment with complicated and frequently changing legal requirements and guidelines. Thus, the capability of independent decision of priorities as well as self-starting capability is implicit as a requirement. Deadlines, cross-functional collaboration, and international communication will be part of your workday.

Qualifications
You have strong skills in interpretation of the regulatory requirements for pharmacovigilance, the clinical area and/or device area both within and outside Europe. You understand the pharmaceutical regulatory environment and have a similar job background from the pharmaceutical industry with a relevant education, e.g. Pharmacist. You have working experience of minimum 5 years with the drug safety, clinical area and/or the regulatory area.

You are good at communicating, negotiating, planning and coordinating multiple activities. You have a very structured approach to your tasks and a high level of responsibility and independence. As a person you are dynamic, careful with your tasks and have a positive attitude to challenges, colleagues and our stakeholders.

We offer an exciting job with lots of challenges and independence among good colleagues in a positive working environment, where you can use your ability for analysis, interpretation and Communication.

At Novo Nordisk, we create value by putting patients first. Every ten seconds two people are diagnosed with diabetes, and close to 366 million people worldwide need us. Working here is not just a way to make a living, but a way to make a difference.

Contact
For further information please contact Mette-Marie Thyge Nøigaard +45 3079 4462.

Deadline
23 May 2013]]>Sat, 11 May 2013 02:59:00 GMThttp://www.novonordisk-jobs.com/job/Bagsv%C3%A6rd%2C-Denmark-Regulatory-and-Safety-Compliance-Professional/2535818/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/Bagsv%C3%A6rd%2C-Denmark-Regulatory-and-Safety-Compliance-Professional/2535818/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Title Principal Statistician/Assoc. Director - Biostatistics
Job Category Medical Information
Job Description PURPOSE:

This is a senior level technical position. Work under minimal supervision, the incumbent is responsible for the delivery of statistical support to NN's clinical development, registration, and marketing support programs. Functions include clinical trial design, data analysis, report writing, and general consultations. The scope of responsibility includes one or more drug development programs.

RELATIONSHIPS:

Reports to Director of Biostatistics. Through project team, works closely with clinicians, medical writers, data managers, regulatory managers, and marketing managers.

ESSENTIAL FUNCTIONS:

CLINICAL TRIAL DESIGN AND ANALYSIS: Under coordination of his/her supervisor, lead the statistics aspect of assigned clinical projects. Assure that statistical and scientific methodologies are fully considered and documented. Under minimum supervision, participate in the review of study protocols, critic and suggest improvement on scientific methodology, write statistical sections, develop plans and perform statistical analysis and presentation. Under guidance, participate in the interaction with medical development, medical writing, regulatory affair, and regulatory agencies. Assure statistical input, analysis, and reports of the highest quality are delivered according to schedule.

CUSTOMER MANAGEMENT: Under coordination of his/her supervisor, participate in meetings or communications with the regulatory agencies (primarily the FDA). Under minimum supervision, manage the relations with NNPI internal customers, including clinicians, medical writers, regulatory staff, and marketing managers.

QUALITY AND PROCEDURE IMPROVEMENT: Participate in the development and update of internal SOPs and working procedures. Assist the head of Biostatistics, lead the department staff keeping abreast with current statistical literature, assure the most current regulatory requirement are followed and sound methodologies are adopted. Keeping abreast and observe general guidance established in the pharmaceutical industry, including FDA guidelines, ICH guidelines, NN SOPs, and generally accepted GCP.

RESOURCE MANAGEMENT: Under coordination with his/her supervisor, prioritize task assignment, timelines, and outsourcing management. Manage the interactions with NNA/S headquarters statistical group through department Director.

STATISTICAL PROGRAMMING AND PRESENTATION: Perform hand-on programming or direct statistical programming staff assure that data listing, tables, and graphs are produced with highest efficiency and quality; Participate in the development and maintenance of statistical routine libraries.

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS

A Ph.D. degree in biostatistics, statistics, or relevant areas required.
Six years of experience in pharmaceutical industry engaged in biostatistical support of clinical development with progressively increasing scope of responsibility.
Demonstrated ability to develop statistical methodology for analyses of clinical data.
Extensive knowledge of statistical computer programming skills.
Good communication and interpersonal skills.
Knowledge of regulatory requirement.
Knowledge of statistical concepts and techniques and of clinical trial principles.
Department CMR - BIOSTATISTICS & STAT PROG (1)
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Doctorate Degree Required]]>Sat, 18 May 2013 05:31:00 GMThttp://www.novonordisk-jobs.com/job/Princeton-Principal-Statistician-Assoc_-Director-Biostatistics-Job-NJ-08540/2557339/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/Princeton-Principal-Statistician-Assoc_-Director-Biostatistics-Job-NJ-08540/2557339/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Title Legal Director, Privacy
Job Category Legal
Job Description PURPOSE:
Responsible for the development, implementation, and maintenance of the Novo Nordisk (NNI) Privacy strategy and program for North America.

RELATIONSHIPS:
Reports to Senior Corporate Counsel with responsibility for advising the company on privacy laws and regulations.

ESSENTIAL FUNCTIONS:
• Formulate enterprise-wide privacy policies and procedures, consistent with applicable U.S. and global laws
• Create content and guide delivery of roles-based education and awareness of privacy issues and their impact to our brand and business
• Act as the company’s privacy subject matter expert with knowledge of applicable state, federal and international laws and regulations including the FTC Act, CAN-SPAM, HIPAA/HITECH and related medical information privacy laws, laws and regulations related to employee privacy, and other global laws and regulations including those implementing the EU Data Protection Directives
• Provide leadership and oversight over cross-functional privacy committee including, but not limited to representatives from marketing, sales, human resources, clinical trial operations, medical affairs, IT, and corporate communications. Liaise with privacy function for NNI parent company to ensure compliance with global policies and procedures, and applicable laws
• Act as key point person (partnering with company stakeholders) for privacy data events/breaches with responsibility for implementing response plan and recommending any needed changes to business practices
• Maintain knowledge of external legal and industry developments in privacy including evolving laws and regulations, and proactively propose advisable business processes or practices
• Through on-going privacy risk assessments, identify areas of potential brand impact and legal consideration and propose and drive solutions
• Maintain knowledge of the relevant information technology systems and applications to drive systematic solutions and improvements
• Liaise with privacy professionals at peer companies and industry organizations
• Partner with company’s government affairs department on legislative and regulatory initiatives related to privacy affecting the company’s business

PHYSICAL REQUIREMENTS:
Not applicable

DEVELOPMENT OF PEOPLE:
Not applicable

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
• A Bachelor's degree is required; JD preferred
• At minimum of 8-10 years of experience with at least 2-4 years of experience in a Compliance department or similar function for global company, with significant experience dealing with healthcare/pharmaceutical privacy matters
• Certification as a Certified Information Privacy Professional highly desired
• In-depth knowledge of applicable state, federal and international privacy laws
• Recognized subject matter expert within the privacy profession
• Experienced in successfully managing a comprehensive privacy program, with ability to prioritize, design, resource and implement program is preferred
• Demonstrated experience making sound risk assessments, and identifying and resolving legal and regulatory issues quickly and effectively and ability to make real-time decisions
• Proven track record as a strong team player with ability to work cross-functionally in a complex organizational structure
• Ability to communicate effectively at all levels of an organization
• Ability to work independently and be pragmatic and results focused
• Can take a dynamic approach to implementing a privacy program
Department LGQ - LEGAL/GOVT & QUALITY AFFAIRS (1a)
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Bachelor's Degree Required
Percent Travel 10 - 20%]]>Sat, 18 May 2013 05:31:00 GMThttp://www.novonordisk-jobs.com/job/Princeton-Legal-Director%2C-Privacy-Job-NJ-08540/2302733/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/Princeton-Legal-Director%2C-Privacy-Job-NJ-08540/2302733/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Title SR DIRECTOR, MARKET DEVELOPMENT - OBESITY
Job Category Marketing
Job Description PURPOSE:
Responsible and lead for the development of the pre-launch and launch Obesity Market strategy, stakeholder engagement strategy, unbranded and branded market shaping strategy, and related initiatives, in alignment with the relevant Global Obesity project launch track and deliverables. This position makes major decisions for key areas of responsibility including:
1) development and support execution the US Obesity Market Strategy and Strategic Relations action plan, in collaboration and coordination with the Global organization, NNI Government Affairs, Medical Affairs and Operations, Managed Market, HCP and Patients Marketing teams,
2) identify all relevant key US Obesity decision makers, influencers and advocates, including healthcare professionals (prescribers, allied health and others Obesity specialists), payers, policy makers and patients groups and organizations,
3) assess stakeholder needs and develop a Novo Nordisk Inc. engagement strategy that supports the Obesity Market strategy, while influencing/aligning with goals of stakeholders, 4) develop market shaping strategy, determine appropriate timing based on Obesity Market and Brand strategy, and execute appropriate initiatives/tactics, through collaboration with cross-functional teams,
5) facilitate the creation of relevant public forum and public dialog around US Obesity issues that align with Obesity Strategy.

Acts as an expert, leader, and cross-functional strategic point person for strategic and tactical execution within designated functional area. Ensures alignment of all Strategic Relations, Engagements and Communications initiatives with US and Global Obesity Launch strategies.

RELATIONSHIPS:
Reports to the Vice President, Obesity. Participates in the US Obesity EBT and relevant Global working groups. Leads US Obesity Market Strategy & Strategic Relations sub-team and relevant cross-functional working groups. Key internal relationships include senior level positions in Medical Affairs, CMR, Government Affairs, Field Execution, Marketing, including but not only Managed Market and Patient COEs, Legal, Regulatory, Business Development (pipeline/pre-launch drugs), Corporate Communication and Global Marketing and Medical Affairs. Other key external relationships include national and international stakeholders and decision makers, from prescribers, to allied health professionals and other Obesity specialists, patients and patient’s organizations, payers and policy makers and professional services vendors. This position provides input to publication strategies and creation and management of NNI Obesity advisory boards and Think Tanks.

ESSENTIAL FUNCTIONS:

Fiscal:
• Budget responsibility with significant impact on revenue.
• Develops and monitors performance against department’s budgets.
• Ensures budgets remain on track.
• Establishes, oversees implementation, and monitors adherence to administrative policies and procedures.
• Evaluates appropriate use of resources to ensure attainment of unit, department and Company profitability goals.
• Reviews and audits staff expense reports.

Product Investment:
• Develops relationships with and receives commitment from relevant departments and NNAS to ensure the successful execution of strategies.
• Maximizes revenue and profitability and understands return on investment (ROI) concepts to ensure program effectiveness.
• Partners with Brand teams to identify key metrics and evaluate ROI/impact of programs; collaborates with Obesity Launch team counter parts in making course corrections if needed.
• Partners with Marketing Effectiveness Leadership to develop and oversee implementation of key metrics (ROI, impact, etc). Regularly reviews current program progress to ensure profitability/budget goals are on track. If not meeting metrics, proactively implements corrective measures to increase business impact and overall value.

Strategic Leadership/Planning:
• Actively participates as a member of the US Obesity EBT and Global working groups shaping strategy, structure, and culture.
• Demonstrates strong leadership role across the organization, by effectively promoting and engaging in close collaboration with key internal stakeholders (eg. Diabetes Portfolio Strategy, Diabetes Market Shaping, Managed Market, Government Affairs, Field Execution, Medical, Legal, Marketing).
• Develops and oversees the implementation of strategic business plans for Obesity. Create and initiate innovative engagement and market shaping strategies. Viewed as a functional expert in this field by internal and external stakeholders. Ensures COE strategies and tactics are aligned with the Obesity brand strategy.
• Develops and presents compelling plans for management endorsement.
• Develops strong relationships with leading key external stakeholders and thought leaders.
• Develops strong relationships/partners with the Medical Affairs, Managed Market, Government Affairs, Corporate Communications, and CMR to ensure key stakeholder relationships are leveraged and aligned with an overall Engagement & Relationship Strategy.
• Forges strong relationships with Global Marketing to maximize US Obesity strategy, market shaping strategy, and engagement & relationship activities.
• Identifies opportunities to coordinate programs across multiple target audiences to ensure scalability, cost savings and alignment.
• Leads development of the Obesity scientific platform and promotional scientific story, including surveillance and evaluation of Obesity publications in collaboration with Medical.
• Leads the development and execution of Obesity strategy, influencer and decision maker mapping, engagement action plan, and tactics considering product lifecycle (new indication, formulation changes, etc.) and within the legal, regulatory and strategic boundaries with our Diabetes business and Victoza in particular.
• Liaises closely with Business Development team to ensure full alignment of activities related to our Obesity pipeline lifecycle strategy and identify areas of synergy.
• Proactively communicates with Brand Lead and COEs to ensure message alignment and sign off prior to implementation.
• Represents as US Obesity leadership at global meetings, where applicable.
• Responsible for effectively managing the Obesity pre-launch and launch budget within targets.
• Understands and monitors complex and evolving compliance landscape. Ensures strategy and plans align with internal policies and external regulations.

PHYSICAL REQUIREMENTS:
Approximately 30 to 35% overnight travel.
Additional Information DEVELOPMENT OF PEOPLE:
• Ensure that reporting personnel have 3P forms with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process.
• Ensure that the IDP forms include completed Learning and Aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility.
• Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way.

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
• A Bachelor's degree and 15 years' experience, including 10+ years' progressive product management/marketing, market shaping or medical education experience within the pharmaceutical industry required. Masters or graduate degree preferred with 10+ years' experience.
• At least 4 years management experience required.
• Demonstrated strategic and collaboration skills in leading cross-functional teams required.
• Excellent presentation/communications skills required.
• Prior team leadership and/or management experience required.
• Proven track record of innovative market shaping accomplishments/high impact results (based on metrics/ROI).
• Solid understanding of the marketplace and competition.
• Strategic Planning, Execution and follow-through skills required.
Department DM - OBESITY
Position Location US - Princeton, NJ
City Princeton, NJ
State/Provinces US - NJ
Degree Required Bachelor's Degree Required
Percent Travel 30 - 40%]]>Tue, 14 May 2013 02:59:00 GMThttp://www.novonordisk-jobs.com/job/Princeton-SR-DIRECTOR%2C-MARKET-DEVELOPMENT-OBESITY-Job-NJ-08540/2547543/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/Princeton-SR-DIRECTOR%2C-MARKET-DEVELOPMENT-OBESITY-Job-NJ-08540/2547543/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Title Medical Director
Job Category Medical
Job Description PURPOSE:

Assist the Sr. Medical Director in developing and implementing the medical affairs strategy for a particular brand within Diabetes. Coordinate medical activities linked to the Brand in conjunction with the Sr. Medical Director. Assist the Sr. Medical Director in managing the program for phase 3b/4 clinical trials program, defining strategies to support medical education programs, reviewing medical and scientific content of promotional materials, maintaining KOL relationships and serving as a consultant for Marketing, FMA, MC&G and Sales. Assist with the development of strategies to appropriately position the Brand as part of the Novo Nordisk portfolio within the continuum of diabetes care. Review the representation of medical affairs in promotional review board (PRB) activities.

RELATIONSHIPS:

This position reports directly to the Sr. Medical Director, Medical Affairs – Diabetes and will assist the Sr. Medical Director in managing multiple internal relationships within Novo Nordisk Inc. and Global HQ. External relationships include expert advisory board members, investigators, other consultants, and key customer groups. Assist in driving the Brand’s Project House Team. Contribute to the Brand’s PPG and EBT.

ESSENTIAL FUNCTIONS:

COMMUNICATIONS/TRAINING: Assists in the review of educational curricula to effectively teach and assist in the training of sales representative, Drug Information specialists, Field Medical Affairs, and Investigators

In conjunction with the Sr. Medical Director may serve as a representative of Novo Nordisk Inc. Medical department in regulatory interactions, investigators’ and expert advisory board meetings, external professional societies, seminars, and conventions

Maintains required credentials and remains in good standing within the medical community and medical ethics boards

Stays abreast of regulatory requirements and guidelines and current trends and medical practice in the field of endocrinology and diabetes, including reports and intelligence on new technologies or treatment advances

MEDICAL COMMUNICATIONS: Assists in developing brand-specific medical education strategy (CME, medical grants, AMCs/professional societies) incorporate into 5 year plans and assess impact

Assists in the development of brand-specific publications strategy (primary, secondary and HEOR), with input from Medical Operations, and Global Publications.

Assists the Director of Medical Education in overseeing NNI support to external medical educations programs

Provides medical input to manuscripts based on clinical trial results and on general diabetes topics

Reviews all brand-specific promotional materials (finalized medical input for PRB)

Supports Medical Information and Field Medical Affairs units

REGULATORY AND SAFETY ACTIVITIES: Assists in assuring the ongoing safety and adequacy of labeling of the Brand from a medical perspective

Assists in the interpretation of regulatory guidelines and directives to judge risk and causality

Assists the Sr. Medical Director in ensuring quality execution by collaborating closely with CTM and FMA in selection investigators/sites, ensuring screening and accuracy, and guiding interpretation.

Assumes primary accountability as representative in Promotional Review Board (PRB) activities. This role requires full knowledge of diabetes product portfolio and understanding of various Federal and Pharma regulations and guidelines as well as in depth knowledge of diabetes disease state.

Supports the definition and implementation of the Brand’s labeling strategy.

SALES AND MARKETING SUPPORT: Assists the Sr. Medical Director in presenting the Brand’s clinical data at regional and national advisory boards

Assists the Sr. Medical Director in providing medical input to the Brand’s market shaping strategy, marketing plans and promotional campaigns

Participates in advisory boards, speaker training, Medical Marketing meetings, and other marketing activities as needed

Participates in the development of medical product support and development plans for the Brand in concert with Sales and Marketing

Supports ongoing sales and marketing objectives by assisting the Sr. Medical Director in making presentations as appropriate to external groups such as academic and community medical departments, professional associations, and P&T committees

Works closely with Medical Information to assure that communication from Novo Nordisk is scientifically accurate and clinically appropriate

STRATEGY AND PROTOCOL DEVELOPMENT: Assist the Sr. Medical Director in developing and executing brand–specific phase 3b/4 trial strategy including prioritization criteria, with input from Marketing and Global, and incorporate into annual and five-year plans, formalizing template and process to streamline protocol design, and developing brand-specific IIS strategy, including prioritization criteria, and support its execution.

Assists Sr. Medical Director in providing NNI medical input on the Brand’s global clinical development plan.

Collaborate closely with HEOR group on brand-related activities (providing input into early economic models/endpoints for phase 1-3, phase 3b/4, guiding trial design, assimilating HEOR input, and supporting data review for secondary publications)

In collaboration with the Sr. Medical Director, build relationships and maintain a strong KOL network

Participate in Medical Marketing discussions regarding local and global clinical trials and assists with the preparation of Local Trial Proposal form as needed

Participates in global publication planning team for the brand, along with NNI Medical Operations.

Provide medical/scientific input into the Brand’s development and marketing strategies in consultation with the Sr. Medical Director

Provides content and ideas for publications run by Medical Operations.

Reviews brand-specific IIS proposals

PHYSICAL REQUIREMENTS:

Must be able to travel and work on weekends 20-30% of the time.

DEVELOPMENT OF PEOPLE:

Not Applicable

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS

An MD or DO and 5 years’ experience, with clinical and prior direct patient care experience

Research or pharmaceutical industry experience in the field of endocrinology and metabolism preferred.

Strong strategic mindset, understanding of market needs, resource allocation, etc?

Strong tactical familiarity with the design, overseeing and assessment of clinical trials and with other MA tools (expertise in clinical trial methodology and conduct, GCP principles, medical product support activities, publications, IIS, med ed).

Subspecialty training in endocrinology and metabolism preferred
Department CMR - MEDICAL AFFAIRS DIABETES (2)
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Doctorate Degree Required
Percent Travel 20 - 30%]]>Fri, 24 May 2013 03:00:00 GMThttp://www.novonordisk-jobs.com/job/Princeton-Medical-Director-Job-NJ-08540/2567595/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/Princeton-Medical-Director-Job-NJ-08540/2567595/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS
- Quality
- Denmark - Bagsværd

Are you a medical doctor who is passionate about patient safety? Then you may be one of our new safety surveillance specialists.

We are seeking medical doctors (MD) with documented clinical and scientific knowledge about diabetes, metabolic conditions or cardiology for two (2) full time positions as Safety Surveillance Specialist in Safety Surveillance Diabetes Insulin & Devices department of Global Safety, in Novo Nordisk A/S.

Drug safety is an integral part of drug development and is now in focus more than ever. In this job, millions of people with diabetes worldwide depend on your medical evaluation of the benefit/risk profile of the Novo Nordisk insulin products.

About the department
Safety Surveillance Diabetes Insulin & Devices is an international department of highly committed and skilled professionals with medical or pharmaceutical background. We have the global responsibility for the safety surveillance of the Novo Nordisk insulin products and devices, marketed or in clinical development.

The job
Your key responsibility will be the ongoing safety surveillance of insulin products. This includes evaluation of the safety data, early detection of safety signals and aggregate reporting hereof, as required by the EU and US legislation. Close collaboration and communication with other functional areas in Novo Nordisk, especially the clinical development team and regulatory affairs team is required.

Your job responsibilities will also include communication with external parties related to clinical safety monitoring, such as Data Monitoring Committees and Event Adjudication Committees.

Qualifications
You have a medical degree (MD) and preferable also scientific training (PhD or equivalent). It will be an advantage if you have previous experience from the pharmaceutical industry, especially from a medical department or a drug safety department. Experience from interactions with regulatory authorities will be a plus. You are a reliable, open-minded and dedicated team player, who thrives in a global environment of continuous development, and focuses on quality of work and the results of the team. Interaction with internal and external experts require proficiency in English, excellent communication, coordination and planning skills.

At Novo Nordisk, we create value by putting patients first. Every ten seconds two people are diagnosed with diabetes, and close to 366 million people worldwide need us. Working here is not just a way to make a living, but a way to make a difference.

Applications must be written in English.

Contact
For further information, please contact Liliana Hansen at +45 3075 0964.

Deadline
10 June 2013.]]>Tue, 14 May 2013 00:00:00 GMThttp://www.novonordisk-jobs.com/job/Bagsv%C3%A6rd%2C-Denmark-Safety-Surveillance-Specialist/2597849/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/Bagsv%C3%A6rd%2C-Denmark-Safety-Surveillance-Specialist/2597849/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Title Executive Director - Hemostasis
Job Category Medical
Job Description To provide medical leadership including the assessment and support of product development and extension, and professional services for Biopharmaceutical marketed products.

RELATIONSHIPS:

This position reports to the Vice President, Clinical Development & Medical Affairs, BioPharm and manages the Clinical Development and Medical Affairs, Hemostasis Team. It is accountable for managing multiple internal relationships within NNI and NNAS. External relationships include working with the medical community and customers.

ESSENTIAL FUNCTIONS:

PROTOCOL DEVELOPMENT
•Conduct needs assessment for therapeutics in healthcare, the risks of intervention and the potential market for intervention.
•Review, refine, prioritize and manage the Hemostasis Clinical Trials Program.
•Develop medical affairs capabilities.
•Manage core project teams between NNI and NNAS to integrate clinical /medical core programs.
PRODUCT SUPPORT AND SAFETY
•Evaluate reports of adverse outcomes, apply clinical medical acumen and interpret regulatory guidelines and directives to judge risk and causality.
•Participate in meetings and the Promotional Review Board (PRB).
•Assure the ongoing safety and adequacy of labeling of NNI's marketed products from a medical perspective.

SALES AND MARKETING
•Provide medical input to marketing plans, promotional campaigns and new product launch platforms.

PRODUCT DISCOVERY AND DEVELOPMENT
•Coordinate Medical Department strategic review of in-licensing candidates and external development projects for NNI’s existing in-line product franchises.

MEDICAL AND PATIENT COMMUNITY
•Must have (and continue to build) relationships with key thought leaders in the hemophilia community.

•Develop educational curricula to effectively teach.
•Serve as an expert in hematology.
•Maintain necessary credentials and remains in good standing within the medical community and medical ethics boards.

DEVELOPMENT OF PEOPLE:
•Ensure that reporting personnel have 3P forms with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process.
•Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way •Ensure that the IDP forms include completed Learning and Aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility.

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
•MD and 5 plus years Industry experience. Pharmaceutical development or
research experience, including expertise in clinical trial methodology and medical product support, and medical affairs.
•Hematology experience specializing in bleeding disorders is required.

•Experience in development and regulatory areas required.
•Previous supervisory experience required.
•Administrative responsibilities in an institutionalized setting required.
•Must maintain necessary credentials and remain in good standing within the medical community and medical ethics boards.
•Previous Phase I-IIIB and IV clinical trials experience required.
•Some clinical and previous patient care experience required.
•Strategic/Tactical planning experience within a pharmaceutical environment is required.
•Able to assess a clinical outcome and relate it to a drug.
Department CMR - HEMOSTASIS
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Doctorate Degree Required
Percent Travel 30 - 40%]]>Tue, 21 May 2013 02:59:00 GMThttp://www.novonordisk-jobs.com/job/Princeton-Executive-Director-Hemostasis-Job-NJ-08540/1786584/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/Princeton-Executive-Director-Hemostasis-Job-NJ-08540/1786584/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS
- Student and Internships
- Denmark - Søborg

At Novo Nordisk, we share a passion for changing patients’ lives, and we are always looking for talented individuals who want to join us in this effort. Our internships provide exciting learning opportunities for students who bring new ways of thinking to our company.

About the department
Our team works with the global marketing activities of our portfolio of current and future devices and needles. We work on developing strategies and tactics in close collaboration with our colleagues in the other global marketing brand teams. We support the implementation of tactics in our regions and locally. Our team interacts with internal and external stakeholders. Internally, we are supporting the drug brand teams for both marketed and future medications. We have a lot of interaction with our colleagues in the countries around the world. We are a main input giver to device life cycle management activities as well as future device innovation projects. Finally, we’re collaborating with a variety of other functions including medical affairs, product supply, regulatory affairs etc. Our external interaction is mainly with marketing research, advertising agencies etc. We’re an international team of highly skilled, high performing project managers working toward making our devices the most preferred in the market.

The job
Professionally you will participate and get experience from working with the development and roll-out of promotional and other materials for our marketed devices. You will be involved and supporting our team members in their day to day liaison with affiliates with regards to marketed devices. Specific projects/tasks to be decided e.g. support to NovoPen® 5 launch planning and execution, launch coordination of FlexTouch®, launch support to specific markets, participation in development of Life Cycle Management activities for our devices etc.

On the personal side, you will gain experience with multiple stakeholder management, execute through and with others, get global insights and you will have opportunities for multi-functional interaction.

Qualifications
We are looking for an intern who is passionate about pharmaceutical marketing and communication. You are currently studying on your master’s degree in marketing, business, economy, pharmacy, engineering or another relevant field. General knowledge of marketing related disciplines and key methodologies (marketing, communication, strategic and tactical planning, market research methodologies) preferred. We expect candidates to be service minded, thrive in a busy environment and bring a can-do attitude. Fluency in both oral and written English; ability to manage a large volume of projects (with supervision); sound personal judgment; and excellent interpersonal skills are required.

You are an outgoing person with a strong personal drive and dedication. You have professional and personal impact that is reflected in your desire to take initiative. In addition, you thrive in a busy environment and bring a can-do attitude and a healthy sense of humour to your work – even when the pressure is on. Finally, you must have strong work ethic and willingness to take responsibility for your own learning.

Practicalities

Students in their first or second year of their master studies.

Period: The internship position is a full-time position for 4-6 months.

Start date: Aug / Sep 2013

Contact
For further information, please call Anders Krabbe on +45 3075 6179.

Deadline
10 June 2013.]]>Tue, 07 May 2013 00:00:00 GMThttp://www.novonordisk-jobs.com/job/S%C3%B8borg%2C-Denmark-Internship-in-Global-Marketing-Devices%2C-Novo-Nordisk/2585881/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/S%C3%B8borg%2C-Denmark-Internship-in-Global-Marketing-Devices%2C-Novo-Nordisk/2585881/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Title Senior In-House CRA
Job Category Clinical
Job Description PURPOSE:
Responsible for the support of assigned sites in accordance with Good Clinical Practice (GCP), ICH guidelines and federal regulations. Close collaboration with other members within Clinical Trial Management (CTM) and with various representatives within Clinical, Medical & Regulatory Affairs (CMR). Responsible for monitoring assigned sites in accordance with GCP/ICH and Novo Nordisk (NNI) SOPs.

RELATIONSHIPS:
Reports to a Manager/Senior Manager of Site Management (SM) within CTM. Accountable for actively participating in multiple internal cross-functional teams locally to ensure the effective delivery of assigned project milestones. External relationships are with clinical investigators, and other clinical research vendors as needed to support business objectives for the department and/or function.

ESSENTIAL FUNCTIONS:

COORDINATION / COMMUNICATION, ADMINISTRATION AND PERSONNEL DEVELOPMENT:
Ensure compliance with the application and communication of all Novo Nordisk® policies, procedures and fundamentals.

FUNCTIONAL SUPPORT:
May participate in continuous improvement processes for function.

PROJECT SUPPORT:
- Accountable for the set up, quality and maintenance of the electronic Trial Master Files (TMF) in accordance with NNI SOPs. Performs ongoing reviews of TMF to assure quality of the documentation files and compliance with NNI SOPs, GCP and ICH Guidelines.
- Accountable to provide develop regulatory documentation to support study start up activities, including all site supplies.
- Act as primary liaison for assigned study sites to convey project information, answer questions and in accordance with the CTM escalation pathway to the Lead CRA resolve site related issues.
- Act as primary liaison for assigned study sites while on-site to convey project information, answer questions and in accordance with the CTM escalation pathway to the Lead CRA to resolve site related issues.
- Arranges for certified translation of study documentation as appropriate.
- Assists the project team in preparation for audits/inspections and is responsible for the quality and completeness of site related performance and documentation. Prepares, collaborates and implements Corrective Action Plans (CAP) with investigative sites with oversight from Lead CRA.
- Attends Investigator Meetings and study-specific training for assigned trials
- Attends site audits according to the CTM Audit Management Plan and executes audit action plans with support from Lead CRA/PM as appropriate.
- Collaborates with the Lead CRA(s) to obtain/share trial specifics issues across all study sites concentrating on areas related to quality, site performance and metrics. Responsible for communicating issues in accordance with the CTM escalation pathway to the Lead CRA(s) and/or CRAs as appropriate.
- Completes follow up letters from all visit types according to SOPs and complete reports to quality standards within company specified timelines.
- Completes Site Selection, Site Initiation, Routine Monitoring and Close-out Visits according to SOPs and completes reports to quality standards within company specified timelines.
- Develops and maintains collaborative working relationships with clinical investigative sites. Accountable for data integrity, patient safety and regulatory compliance for all assigned sites.
- Ensure all regulatory documents and study supplies are maintained during the lifecycle of any assigned project in collaboration with the assigned CRA.
- Liaises with Clinical Budget Management to secure confidentiality agreements, master services agreements, clinical trial agreements as appropriate. Uses this information to prioritize sites for Greenlight approval.
- Monitors recruitment and data quality while on site and remotely through EDC systems/communication with sites.
- Performs on-site drug accountability and reconciliation. Verifies drug storage meets protocol and SOP requirements.
- Preparation and review of various study related tracking systems to determine and report status of clinical trial documents (distribution, status, retrieval of such documents as protocol, IB etc) and responsible for the follow up to collect outstanding documents.
- Provides quality overview and consistency check on all developed ICFs and completes the informed consent checklist.
- Responsible for maintaining current Investigator Trial File (ITF) in accordance with NNI SOPs. Performs ongoing reviews of ITF to assure quality of the documentation files and compliance with NNI SOPs, GCP and ICH Guidelines while on site.
- Responsible for the submission and correction of regulatory green light packages to the Quality Management Group within CTM for approval.
- Responsible to coordinate and secure IRB approval (local and central). Responsible to provide step by step guidance and partnership with sites to secure IRB approval.
- Understanding of assigned protocol (s) and trial specific manuals/plans to ensure quality and deliverables are met across assigned sites.

STAFF DEVELOPMENT:
- May provide active mentorship of CTM staff to build talent across the department.

TEAM COORDINATION:
- Accountable for the compliance and quality of CATS reporting.
- Active membership to local project teams.
- Participates in cross-functional teams, locally, to assure timely attainment of project milestones.
- Responsible to conduct oneself in accordance with expectations as a project team member to ensure the success of a matrix management structure.
- Responsible to ensure that the mandatory trial entries are made in IMPACT, NovoDOCs, iSITE, EDC administration and updates, and ensure CSIM entries and updates are made.
- Responsible to maintains focus, locally, for specific project activities within CMR priorities.

TRAINING:
- Attend relevant symposia, conferences and scientific meetings, as necessary
- Provide support of training needs across CTM and may support the creation, development and potentially provide training support to meet those needs. This includes any lessons learned sharing across the project team members and/or CTM.

PHYSICAL REQUIREMENTS:
- Approximately 50% overnight travel to visit assigned sites for monitoring and/or trainings as required
- Office Based in Princeton, NJ.

DEVELOPMENT OF PEOPLE:
- Active mentorship of CTM staff to build talent across the department.
- May support in the identification of training gaps, may support the development of training materials to meet that gap and then provision of training as required to improve core competency and skill set of the department.
- May support the maintenance of guidelines, training programs, policies and procedures.

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
- A Bachelors’ degree (in life science discipline) or BSN; Advanced degree preferred.
- A minimum of 6 years of clinical trial experience within pharmaceutical and/or healthcare setting,
- Direct expertise of site management and logistical execution of clinical trials for 3 years.
- Demonstrated computer skills (MS Office, MS Project, PowerPoint).
- Demonstrates core understanding of medical terminology and clinical trial activities in relation to execution of a clinical development plan.
- Knowledge of GCP as relates to clinical trial management.
- Previous on site monitoring experience required.
Department CMR - SITE MANAGEMENT (1a)
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Bachelor's Degree Required
Percent Travel 40 - 50%]]>Sat, 04 May 2013 03:00:00 GMThttp://www.novonordisk-jobs.com/job/Princeton-Senior-In-House-CRA-Job-NJ-08540/2531552/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/Princeton-Senior-In-House-CRA-Job-NJ-08540/2531552/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Title Assoc. Director/Director, Health Economics Outcomes Research
Job Category Medical Information
Job Description PURPOSE:
The Associate Director/Director will be responsible and accountable for setting strategy for HEOR/value communication in collaboration with the brand leads/managed markets liaisons for the products throughout their lifecycle He/she will develop and implement US HEOR strategy for one or multiple therapeutic area(s) through personal research, consultants and internal stakeholders. He/she will design and perform health economic and outcome research projects/studies focusing on value, positioning and unmet needs of pipeline and newly launched Novo Nordisk products in order to support best possible market access.

The Associate Director/Director will be responsible for all aspects of effective project management, including RFP development, selection of research partners, contract execution, budget planning, protocol design, analytic plan development, oversight of data collection/acquisition, data analysis, and development of research findings into publications and into field resources/deliverables in alignment with brand and channel strategies.

The position will provide a lead in the initiation, development and implementation of world-class health economics and reimbursement strategies across assigned products. This is done under the direction of the Executive Director of Health Economics and Outcomes Research (HEOR).

This role will align HEOR strategies with Brand Marketing, Pricing and Contracting Operations (PCOR), Managed Market Sales, and Medical & Scientific Affairs. This is a technical position with project-specific strategic responsibilities. The incumbent is responsible for the delivery HEOR research in support of NNI projects in clinical development as well as for marketed products. This is a highly independent position sustained by the training, experience, and judgment of the incumbent. In addition, this position sets strategies with expertise in the design and application of economic/outcomes value research during all phases of product life cycles. Works in close collaboration with HEOR Field Managers in field execution of strategic research initiatives and represents Novo Nordisk with brand value discussions during customer presentations, contract negotiations, and at scientific conferences (international & domestic).

Through extensive interaction with MM Strategy and relevant Brand Marketing teams, this position will assist in building comprehensive value arguments to improve market access and utilization, thereby increasing product performance and achieving business goals and improving patient outcomes.

RELATIONSHIPS:

Reports to the Director or Executive Director, Health Economics and Outcomes Research and works closely with HQ and field HEOR colleagues and Managed Market Sales. Other home-office relationships include Customer Channel Directors, Brand Marketing teams, Medical Writers, PCOR members, and Medical personnel. Works closely with Global HEOR and Global Marketing colleagues in corporate headquarters. Field-based relationships include clinical and academic KOL relationships, consultants & vendors, and professional associations/conferences.

ESSENTIAL FUNCTIONS:
HEALTH ECONOMICS & OUTCOMES RESEARCH:

Acts as a HEOR champion to continually educate the organization on the latest developments and thinking in HEOR as it relates to Evidence Based Medicine, PRO regulatory processes, and reimbursement policies.

Acts as a home-office liaison and key contact point for HEOR/Managed Markets Strategy with Brand Marketing, Medical/Scientific Affairs, Medical Writing, and HEOR Field Managers.

Collaborates with home office and field-based Health Economics Managers in the execution of studies and implementation of field-based, customer-focused initiatives (e.g., models, presentations, publications, slide kits, formulary/regulatory dossiers).

Coordinates necessary US and global randomized and observational clinical data to create and include economic arguments.

Designs and develops pharmacoeconomic models, including decision analytic models, cost-effectiveness models, budget impact models and disease treatment models to support the market access and performance of Novo Nordisk portfolio brands.

Develops and/or coordinates the development of product dossiers.

Develops research plans, protocols and budgets, conducts analyses, and prepare drafts and final reports, abstracts, and manuscripts.

Identifies and maintains successful research relationships with HEOR key opinion leaders and other clinical/academic consultants.

Incorporates business requirements/concerns of top tier customers into analytic tools and results-focused approaches.

Leads the development of HEOR strategies and assist in creating tactics for economic value & quality of life arguments during product development and launch to support pricing and reimbursement across primary customer segments.

Provides additional internal training on HEOR methodologies and data results to Medical & Scientific Affairs and Brand Marketing colleagues.

Provides technical oversight and guidance to research and research support staff. Serve as an internal expert and key resource for research design, methodologies, analytic techniques and reporting of health economic and outcomes research.

Supports HQ HEOR staff in working with Global Marketing and Global Development within Novo Nordisk corporate offices to develop core value protocols.

Works closely with Medical Writers & HQ HE managers to ensure scientific conference material is appropriate, relevant and accurate.

Works with Medical Affairs to help influence Phase IV clinical trial design, inclusion of appropriate value endpoints/metrics, data analysis and publications, as appropriate.

PHYSICAL REQUIREMENTS:

Approximately 35 % overnight travel

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS

A PhD health economics, epidemiology, outcomes research, public health, business/health services research, biostatistics,

OR

PhD/MD/PharmD with an MPH with emphasis in the area(s) of health economics, epidemiology and/or outcomes research

OR

MPH with a focus in Epidemiology, health economics and/or outcomes research and at least 7 years demonstrated experience in HEOR.

At least 5 years (or as above, 7 years with MPH alone) of experience in health economics, outcomes research, pricing, reimbursement, and/or portfolio analysis, with at least 2-3 years in the pharmaceutical industry, preferably with focus in diabetes or chronic care

Advanced knowledge and experience in conducting health economics, health related quality of life, and/or health services research studies and the evaluation of health care interventions

Demonstrable record of peer-reviewed scientific publications, dossier development, and strategic, customer-focused HEOR tool development

Excellent process and project management skills required including the ability to manage a significant volume of projects with exercise of good triage and judgment skills

Experience in preparing or reviewing materials for drug formularies

In-depth knowledge of health care systems in the U.S., including managed care organizations, PBMs, Medicare, and Medicaid

Proven record of outstanding written and verbal communication and negotiation skills, with experience interacting with and presenting to key customers
Department CMR - HEOR (2)
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Doctorate Degree Required
Percent Travel 30 - 40%]]>Wed, 01 May 2013 00:00:00 GMThttp://www.novonordisk-jobs.com/job/Princeton-Assoc_-Director-Director%2C-Health-Economics-Outcomes-Research-Job-NJ-08540/2574719/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/Princeton-Assoc_-Director-Director%2C-Health-Economics-Outcomes-Research-Job-NJ-08540/2574719/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Title SR MANAGER, STRATEGIC COMMUNICATIONS - OBESITY
Job Category Marketing
Job Description PURPOSE:
• This position is accountable for helping create the communications strategy for Novo Nordisk Inc. in the field of obesity. This position will be responsible for developing the core communications story around obesity and unbranded medical education. The role will work closely with stakeholders to develop public policy initiatives and coordinate engagement with third parties. The position will conduct internal message training with executive management and other stakeholders and work with other departments to ensure close alignment, integration and coordination of related strategies. This position will lead the execution of strategic communications, as well as help direct the efforts of public relations agencies to ensure successful program execution and measurement.
• Through effective communications and issues management tactics and strategy, this position: collaborates with communications counterparts to enhance visibility/positive image of Novo Nordisk and the obesity franchise, create brand awareness, condition the market for product entry by helping build allies and scientific/medical case for brand, create anticipation for new products, proactively and reactively blunt competitive efforts, anticipate and manage key stakeholder perceptions, minimize negative media coverage, influence public opinion, establish linkages between/among Communications, BioPharm and Diabetes Marketing to fully leverage product and corporate opportunities, integrate brand/portfolio strategies and objectives into product communications initiatives.
• Through these efforts, this position contributes to the achievement of brand and corporate objectives, including attaining sales goals and improving Novo Nordisk’s overall reputation.

RELATIONSHIPS:
• Key external relationships include media and obesity opinion leaders; professional and patient/consumer third party groups; and public relations agencies.
• This position reports to the Vice President, Obesity, and interacts with all areas within Novo Nordisk Inc. and Novo Nordisk A/S regarding communications programs, goals and needs. In addition to obesity marketing, this position partners with Government Affairs, Clinical, Regulatory and Medical, Launch teams, Product Communications, Communications & Public Affairs, Legal, Compliance and other global business functions. Key relationships in Novo Nordisk A/S include global marketing, corporate communications, and corporate branding.

ESSENTIAL FUNCTIONS:

Issues Management:
• Develops communications plan around issues, collaborating across work groups to ensure accurate information to the media and consumers.
• Prepares for and manages issues.
• Strategizes and collaborates with Product Communications and Communications & Public Affairs to ensure effective integration, alignment, and collaboration on execution to minimize impact on overall Company reputation.

Measurement:
• Charts and reports progress and adjusts plans/tactics accordingly.
• Collaborates with brands to establish meaningful and brand-aligned objectives and measurements for product communications programs that are aligned with business goals.
• Ensure integration of branded programs and messaging into C&PA media efforts, alignment on measurement tools.
• Holds agencies accountable for delivering on measurement targets.

Strategic/Product Communications:
• Assists in the development and implementation of proactive communications and media relations strategies to support the brand/portfolio business goals and strategies of Novo Nordisk. Programs are closely aligned to specific business objectives. Other projects and responsibilities, as assigned.
• Assists in the development of brand message platforms and materials, prepares/coaches internal spokespeople for media interviews and external speaking opportunities; and works with reporters to shape/influence story coverage.
• Cultivates relationships with patients and celebrity ambassadors using NNI brands, contract negotiation, and program management as assigned.
• Ensures close coordination with the communications and public affairs unit, ensuring plans are integrated, aligned and coordinated with corporate branding, media relations strategies, etc.
• Follows internal and external procedures in managing contracts. Regularly tracks and reconciles expenses to ensure budget is on track.
• Helps drive positive media coverage for assigned Novo Nordisk products in various media venues to enhance visibility of company and its brands.
• Helps manage communications budgets; accountable for executing programs within budget parameters. Accountable to manage the budget process for designated scope. Monitor agency expenses by looking for opportunities to maximize value while minimizing agency costs.
• Identifies external resources needed to implement public relations programs; directs agency or consultants in tactical execution of various programs; and conducts reviews/assessments of agency performance twice per year.

PHYSICAL REQUIREMENTS:
Approximately 30% overnight travel.

DEVELOPMENT OF PEOPLE:
Not Applicable.

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
• A bachelor’s or higher degree in journalism, public relations, english or a related communications discipline required.
• At least 8 years of strategic or product communications, media or public relations experience required, preferably in the pharmaceutical industry.
• Disease market knowledge within obesity, diabetes, cardiovascular and cardiometabolic markets.
• Must have strong media relations skills, pre-existing relationships with reporters, patient opinion leaders, etc.
• Prior launch experience desirable.
• Proven strategic planning, issues/crisis management skills are essential for this position.
Department DM - OBESITY
Position Location US - Princeton, NJ
City Princeton, NJ
State/Provinces US - NJ
Degree Required Bachelor's Degree Required
Percent Travel 20 - 30%]]>Tue, 14 May 2013 02:59:00 GMThttp://www.novonordisk-jobs.com/job/Princeton-SR-MANAGER%2C-STRATEGIC-COMMUNICATIONS-OBESITY-Job-NJ-08540/2547544/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/Princeton-SR-MANAGER%2C-STRATEGIC-COMMUNICATIONS-OBESITY-Job-NJ-08540/2547544/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Title Senior Manager - Medical Affairs - Scientific Strategy
Job Category Field Medical
Job Description PURPOSE:

This position will develop scientific resources, communication and training materials for the diabetes medical affairs (MA) team; and will work closely with the MA management team and other internal stakeholders such as Clinical, Medical Information, Marketing, Market Shaping, Sales Operations, and CMR Training to assist in the implementation of scientific initiatives focused on both internal and external customers. To ensure accurate, timely and current medical updates to scientific communications materials and resources in use by the MA team related to current and future diabetes treatment modalities and guidelines. Create, review, update and archive MA slide libraries, Field MA (FMA) clinical reading binders, new hire material, product-specific key studies and other material for use by medical professionals within Novo Nordisk. Serve as resource to the overall MA team in product and disease state scientific resources and education as directed by MA management. This position may focus on specific products and/or customer groups as determined by the business needs. Projects will be allocated across team members to optimize workflow and according to business priorities.

RELATIONSHIPS:

Position reports to the Associate Director, Medical Affairs Scientific Strategy & Communications. Additional key internal relationships include MA internal and field management, MA project management, Medical Communications, CMR Training, Clinical Trial Management, Clinical Development, Marketing and Market Shaping.

ESSENTIAL FUNCTIONS:

• Act as a scientific resource for the MA team.
• Act as a scientific resource liaison between FMA team and Field Medical Canada, BioPharm, Medical Education and Medical Information Departments.
• Act as point person to represent the MA team to liaise with key internal stakeholders cross-functionally on appropriate projects
• Assist home office medical strategy & operations (MSO) team in responding accurately and timely to scientific information requests from the MA team.
• Assist home office Scientific Strategy & Communications team in the coordination and training of sales representatives on disease state knowledge as requested.
• Assist in preparation and implementation of MA scientific training initiatives in collaboration with CMR Training. This includes new hire scientific training, ongoing scientific training (Tele/Web-conferences or live training at Regional and National meetings) and other initiatives to ensure MA Team members have the most current medical and scientific information and “best in class” clinical support.
• Assist MA team in preparing for major presentations or major managed care meetings as requested.
• Coordinate all FMA activities related to scientific conventions, work with FMA leadership team to identify and cover relevant scientific sessions, work with other departments to secure FMA personnel support at Novo Nordisk Medical Booths/lounges and for overall coordination.
• Coordinate with Clinical Strategy Director, Brand Medical Directors and with Competitive Intelligence teams for regular MA updates on ongoing and anticipated clinical trials in support of Novo Nordisk brands and those related to competitive products.
• Coordinate with Product Safety to provide relevant updates to FMA team
• Develop and maintain scientific knowledge database for the MA team.
• Keep the MA team updated on new information related to diabetes.
• Maintain and update the Diabetes Medical Slide Library for use by MA team.
• Partner closely with FMA Management Team, to ensure field management input and alignment on all initiatives.
• Prepare and communicate scientific material and clinical updates to the MA team on an ongoing basis and in advance of new data roll-out, new product launches, speaker training programs, and other venues as directed by MA management.
• Submit all medical slides and other scientific resources for appropriate medical and legal review to assure compliance with standardized review processes of materials used by professionals in the MA Team.

KEY SUCCESS FACTORS:

• PharmD preferred with a minimum of 3 years of academic or industry experience or doctoral degree (PharmD, PhD, MD or DO) with 2-3 years of Medical information/Affairs experience.
• Between 2 to 3 years of field medical experience strongly preferred.
• Demonstrated understanding of legal and regulatory environment of pharmaceutical industry.
• Possess superior communication skills, both oral, written and presentation, and ability to engender trust and respect of peers and superiors.
• Presentable, highly articulate, goal-oriented, honest, with high integrity and strong ethics.
• Proficiency in PowerPoint, Excel and MS word software applications and overall advanced computer skills with knowledge of literature search techniques required.
• Proven track record of strong team work, innovation, and project management
• Strong diabetes knowledge and keen understanding of diabetes therapeutics preferred.

PHYSICAL REQUIREMENTS:

Ability to drive to or fly to various meetings – approximately 15% overnight travel. Some international travel
may be required.
Department CMR - FMA SCIENCE
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Doctorate Degree Required
Percent Travel 10 - 20%]]>Tue, 21 May 2013 00:00:00 GMThttp://www.novonordisk-jobs.com/job/Princeton-Senior-Manager-Medical-Affairs-Scientific-Strategy-Job-NJ-08540/2609790/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/Princeton-Senior-Manager-Medical-Affairs-Scientific-Strategy-Job-NJ-08540/2609790/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS
- Medical
- Denmark - Greater Copenhagen area

In this job, we offer an exciting career with lots of challenges, personal and professional development among good colleagues in a positive working environment.

About the department
The job is located in Novo Nordisk Danish affiliate based in Copenhagen. As Medical Advisor you will be part of a team of three dedicated Medical Advisors with focus on diabetes medical affairs strategic and field operations in Denmark.

The Job
Reporting directly to the Clinical Medical and Regulatory Director DK & NO, the Medical Advisor will drive medical activities within the territory such as local meetings with specialists, general practitioners and hospital departments. The Medical Advisor is expected to provide medical input for the development of medico-marketing strategy, sign-off on promotional material, deliver internal and external medical information and education. The role will involve liaison with Key Opinion Leaders and investigators.

Qualifications
To be considered for the role you must have a medical degree, preferably with clinical experience within endocrinology. You have a proactive mind-set and a strong can-do attitude, and you are able to work independently.This position requires scientific expertise, strategic thinking, resource management skills, and preferably Good Clinical Practice experience. You must be fluent in Danish, hold a valid driver’s licence and be willing to travel within the territory most working days. Approximately 25 days of international travel per year should also be expected.

At Novo Nordisk, we strive for excellence. As a world leader in diabetes care and a major player in haemostasis management, growth hormone therapy and hormone replacement therapy, we offer our employees opportunities for continuous growth.

Contact
For further information, please contact Ralf W. Ackermann at +45 3075 3297 or Josefin af Petersens at +46 706 38 89 46.

Deadline
31 May 2013]]>Tue, 21 May 2013 00:00:00 GMThttp://www.novonordisk-jobs.com/job/Copenhagen-Medical-Advisor/2609792/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/Copenhagen-Medical-Advisor/2609792/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Title SR DIRECTOR - MARKET SHAPING
Job Category Marketing
Job Description PURPOSE:
• Accountable to lead the strategic direction of market shaping business plans across the entire diabetes portfolio. Develops and coordinates COE area strategies and tactics based on the overall brand/portfolio strategy. Acts as the functional expert in designated area. Acts as a leader and point person for strategic and tactical execution within designated functional area. Ensures alignment of all initiatives with brand strategies. Participates in some of the diabetes governance bodies (e. g. DOT (ad hoc), EBTs, MedMar/and leads the Extended Market Shaping team) to ensure market shaping strategy is aligned with the overall diabetes strategy.
• Interacts extensively with other functions within Novo Nordisk at senior levels – medical affairs and sales. Has leadership responsibility for a team of direct reports. Participates as an active member of the Diabetes Marketing Leadership Team in shaping strategy, structure and culture.
• This position makes major decisions for key areas of responsibility including KOL mapping, influence, and advocacy (branded/promotional programs), supporting non promotional content (publication strategies), advisory boards, Certified Diabetes Educator (CDE) program management, National Programs (speaker bureau strategy and programs, NDEI, PriMed) and Interface programs with the VP’s endorsement.

RELATIONSHIPS:
Reports to the Vice President, Diabetes Marketing. Key internal relationships include senior level positions in medical affairs, CMR, Diabetes Sales, Marketing, Legal, Regulatory, Business Development (pipeline/pre-launch drugs) and International Marketing/Medical. Other key external relationships include national and international key opinion and thought leaders and professional services vendors.

ESSENTIAL FUNCTIONS:

FISCAL:
• Budget responsibility of approximately $30 Million with significant impact on revenue.
• Develops and monitors performance against department’s budgets.
• Ensures budgets remain on track.
• Establishes, oversees implementation, and monitors adherence to administrative policies and procedures.
• Evaluates appropriate use of resources to ensure attainment of unit, department and Company profitability goals.
• Reviews and audits staff expense reports.

PRODUCT INVESTMENT:
• Develops relationships with and receives commitment from relevant departments and NNAS to ensure the successful execution of strategies.
• Maximizes revenue and profitability and understands return on investment (ROI) concepts to ensure program effectiveness.
• Partners with Brand teams to identify key metrics and evaluate ROI/impact of programs; collaborates with brand teams in making course corrections if needed.
• Partners with Marketing Effectiveness Leadership to develop and oversee implementation of key metrics (ROI, impact, etc.). Regularly reviews current program progress to ensure profitability/budget goals are on track. If not meeting metrics, proactively implements corrective measures to increase business impact and overall value.

STRATEGIC LEADERSHIP/PLANNING:
• Actively participates as a member of the Diabetes Marketing Leadership team in shaping strategy, structure, and culture.
• Demonstrates strong leadership role across the organization, by effectively promoting and engaging in close collaboration with key internal stakeholders (e.g. Sales, Medical, Legal, Diabetes Marketing).
• Develops and oversees the implementation of strategic business plans for portfolio market shaping. Viewed as a functional expert in this field by internal and external stakeholders. Ensures COE strategies and tactics are aligned with brands and based on the overall brand/portfolio strategy.
• Develops and presents compelling plans for management endorsement.
• Develops strong relationships with leading key opinion leaders/thought leaders to integrate into market shaping activities.
• Develops strong relationships/partners with the Medical Affairs unit within CMR to ensure KOL/HCP relationships are leveraged and aligned with an overall KOL Relationship Management Strategy.
• Forges strong relationships with International Marketing to maximize portfolio market shaping activities.
• Identifies opportunities to coordinate programs across multiple brands/portfolio to ensure scalability, cost savings and alignment.
• Leads the development and execution of portfolio market shaping plan/strategy for products considering product lifecycle (new indication, formulation changes, etc.).
• Leads the Extended Market Shaping Team as part of the Diabetes Governance Structure, and ensure outputs are fed into other governance bodies (e.g. DOT, EBTS, MedMar).
• Liaises closely with Business Development team to ensure full alignment of market shaping activities for pipeline and pre-registration drugs with marketed brands, and identify areas of synergy.
• Oversee integration of promotional medical education into Novo Nordisk’s business planning process.
• Oversees development of the strategic publication plan (for all brands) in collaboration with Medical, to drive brand key messages maximizing reach and impact.
• Proactively communicates with Brands to ensure message alignment and ‘sign off’ prior to implementation.
• Proactively identifies strategies, activities and future direction for market shaping based on best practices. Makes appropriate recommendations to Senior Management Team.
• Provides leadership oversight in ensuring the effective alignment of market shaping tactics across the brands and customer segments (e.g. Endos, PCPs, KOLs, Payors, Patient Marketing) to impact and influence prescribing behaviors.
• Represents Novo Nordisk at International meetings, where applicable.
• Responsible for effectively managing the portfolio market shaping budget within targets.

PHYSICAL REQUIREMENTS:
Approximately 25-30% overnight travel.
Additional Information DEVELOPMENT OF PEOPLE:
Ensure that reporting personnel have 3P forms with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process.
Ensure that the IDP forms include completed Learning and Aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility.
Leads, directs, motivates, inspires, develops and coaches direct reports.
Manages the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way of Management.

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
• A Bachelor’s degree and 15 years’ experience, including 10+ years’ progressive product management/marketing, market shaping or medical education experience within the pharmaceutical industry required. Masters or graduate degree preferred with 10+ years’ experience.
• At least 4 years management experience required.
• Demonstrated collaboration skills in leading cross-functional teams required.
• Excellent presentation/communications skills required.
• Prior team leadership and/or management experience required.
• Proven track record of innovative market shaping accomplishments/high impact results (based on metrics/ROI).
• Solid understanding of the marketplace and competition, preferably within diabetes.
• Strategic Planning, Execution and follow-through skills required.
Department DM - MARKET SHAPING
Position Location US - Princeton, NJ
City Princeton, NJ
State/Provinces US - NJ
Degree Required Bachelor's Degree Required
Percent Travel 20 - 30%]]>Wed, 01 May 2013 00:00:00 GMThttp://www.novonordisk-jobs.com/job/Princeton-SR-DIRECTOR-MARKET-SHAPING-Job-NJ-08540/2577022/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/Princeton-SR-DIRECTOR-MARKET-SHAPING-Job-NJ-08540/2577022/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS