http://www.novonordisk-jobs.com/feeds/adverse-event-nj-jobs/ Custom RSS Feed for adverse-event-nj-jobs Sat, 25 May 2013 16:51:05 GMT en-us /sites/novonordisk/images/Novo_Banner.gif http://www.novonordisk-jobs.com/feeds/adverse-event-nj-jobs/ 720 Title Associate Director-Government Affairs - State Lobbyist (South Central)
Job Category Government Affairs
Job Description PURPOSE:
• Conducts the strategic lobbying activities in designated Region, including approximately 12 states. Owns the development, advocacy, communications and execution of key business and triple bottom line legislative initiatives and issue response in the states, both for diabetes and BioPharmaceutical issues.
• Accountable for identifying business risks and developing defensive and responsive strategies to address legislative and public policy initiatives that could also affect patient access to NNI therapies or the ability of the company to develop or market its products.
• In consultation with Managed Markets Accounts executives, initiates strategies to maximize Novo Nordisk’s positioning on state formularies.
• Collaborates with Managed Care executives and field sales staff to implement state strategies that promote the Novo Nordisk brand and/or issues and/or relationships in the States.
• Oversees and directs the activities of contract lobbyists in several states in the region.

RELATIONSHIPS:
• External relationships include: Governors and staff, Legislators and staff, Public Health officials, including the State Health Directors, Diabetes Prevention and Control Programs and other state health agencies. Owns the relationships with various national and regional business, policy and political organizations, such as Governors’ Associations, National Conference of State Legislators, National Black Conference of State Legislators, National Hispanic Conference of State Legislators, and the Council of State Governments. Owns the relationship with the state arms of major trade associations, BIO and PhRMA, and interacts, as necessary, with many other external parties, including physician and patient groups, state diabetes and other health-related coalitions, medical departments of Universities, trade associations, law firms, professional associations, vendors, consultants, contract lobbyists and customers.
• Internal relationships include: Legal, Managed Markets Sales and Strategy, National Changing Diabetes Program, BioPharmaceuticals, Medical, Institutional and DCS Sales, Political Action Committee and NNAS.
• Reports to Director, State Government Affairs
• Provides mentoring, guidance, and counsel to less senior staff.

ESSENTIAL FUNCTIONS:
• Develops and executes strategic action plans on wide variety of public policy and business issues of importance to NNI in the geographic region, including issues affecting diabetes care and biotechnology industry interests
• Advocates with key government officials, legislative committees and other entities the incorporation of Novo Nordisk’s position into state legislative and public policy initiatives of importance to the Company and to patients who rely on NNI therapies.
• Assists in Political Action Committee activities
• Builds, fosters and maintains beneficial relationships with:
-patient, health care professional, and health advocacy groups
- key government officials, legislative committees and other entities that define or influence state policy decisions affecting Novo Nordisk or the patients who rely on our therapies
• Defines contract lobbyist responsibilities and directs activities in order to execute action plans designed to maximize Novo Nordisk's impact on policy makers and patients
• Directs interaction of state health initiatives with Novo Nordisk’s National Changing Diabetes Program initiatives
• Drafts letters, policy statements, and testimony for relevant public officials and entities
• Drafts memos, educational materials, and presentations, as necessary, for the senior Novo Nordisk business and government affairs leadership detailing the impact of government decisions on the company’s business and public policy interests
• Oversees and directs vendor activities for state events
• Plans and executes events for state and local officials designed to increase awareness of Novo Nordisk and diabetes issues and oversees and directs related vendor activities
• Responsible for the effective and efficient use of State Government Affairs annual budget
• Collaborates with Managed Markets, Medical Affairs, Marketing and Sales colleagues to mitigate adverse government decisions and to secure appropriate reimbursement for Novo Nordisk products under federal and state health programs
• Assures strict adherence to lobbying disclosure and other ethical requirements applicable to government relations activities within each state in the region

PHYSICAL REQUIREMENTS:
• Approximately 30% overnight travel

DEVELOPMENT OF PEOPLE:
• Not Applicable

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
• A Bachelor’s degree required; advanced degree preferred
• Lobbying experience, demonstrated ability to effectively deliver information, and explain, advocate and negotiate with a broad spectrum of individuals
• At least 10 years of progressive experience with federal or state legislative, executive and public-policy-making bodies required
• Experience with and understanding of the diabetes therapeutic area preferred
• Experience working with healthcare industry associations, physician or patient groups required, demonstrating an understanding of healthcare and pharmaceutical issues.
• Experience working in a matrixed relationship with sales, managed markets and medical affairs colleagues on public policy matters required
• Results-focused – prior track record required
• Travel required, including travel to NNI’s Princeton office
• Previous supervisory experience preferred
Additional Information to be opened as AD- Government Affairs- State Lobbyist
job code A454C
Department HR - GOVERNMENT AFFAIRS (2)
Position Location US - Field Based - Across US
City South Central US
State/Provinces US - NJ
Degree Required Bachelor's Degree Required
Percent Travel 20 - 30%]]>Thu, 09 May 2013 03:00:00 GMThttp://www.novonordisk-jobs.com/job/Princeton-Associate-Director-Government-Affairs-State-Lobbyist-Job-NJ-08540/2540837/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/Princeton-Associate-Director-Government-Affairs-State-Lobbyist-Job-NJ-08540/2540837/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS
- Quality
- Denmark - Bagsværd

Are you interested in clinical trials and pharmacovigilance? – Then we have the right job for you.

About the department
We are looking for 4 Event Adjudication Advisers to join the event adjudication adviser group from 1st of August 2013. The event adjudication group consists of 12 highly engaged colleagues from various academic backgrounds; who work in a fast-paced environment reflecting the increasing demands from numerous long term clinical trials and regulatory authority requirements. In an increasing number of trials, certain clinical adverse events are required to be adjudicated. Event adjudication is a process where an independent review board of medical specialists assesses the relevant events for fulfilment of pre-defined clinical criteria.We belong 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. The department is situated in the House of Quality in Bagsværd.

The Job
As an event adjudication adviser you will be responsible for coordinating, driving and interacting with stakeholders across Novo Nordisk and being the link to international external service providers. Project management, process setup, on-going event tracking, documentation review, and creating and communicating reports are examples of what this dynamic role comprises of. The role varies according to the life of a clinical trial with regard to pace and task type. Some of these tasks are data and database driven. We are a rapidly growing department with a high focus on continuous improvement, so optimization tasks will also be part of the job.

Qualifications
You have a Bachelor or Master degree, preferably within biomedical sciences (e.g. Medicine, Pharmacy, Veterinary) or related discipline. You speak and write English fluently. Experience in pharmacovigilance, event adjudication would be an advantage but not a must. You have a flair for IT systems and are highly skilled in MS office, specifically Excel. You are good at communicating, planning and coordinating multiple activities. You have excellent cooperative skills and a high degree of flexibility. As a person you are dynamic, eager to learn new processes, careful with your tasks and have a positive attitude to challenges. You must be able to work against tight deadlines.We offer an exciting job with lots of challenges among good colleagues in a positive working environment.

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 about the job please contact Poonam Rihel, at +45 3079 1131 or Claudia Pierleoni-Nielsen, at +45 3075 9671.

Deadline
2 June 2013]]>Thu, 16 May 2013 00:00:00 GMThttp://www.novonordisk-jobs.com/job/Bagsv%C3%A6rd%2C-Denmark-Event-Adjudication-Adviser/2602662/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/Bagsv%C3%A6rd%2C-Denmark-Event-Adjudication-Adviser/2602662/?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
- 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
- Quality
- Denmark - Bagsværd

Safety Operations is looking for a competent and dedicated Safety Operations Quality & Training expert.

About the department
Safety Operations is part of Global Safety within Global Quality. Global Safety has the overall responsibility for surveillance of the safety of Novo Nordisk clinical development and marketed products. Safety Operations is responsible for the global handling and reporting of adverse event reports. Our Area is located in Bagsværd and consists of 80 employees. The vacant position is placed in Safety Operations Quality and Training department which is responsible for Quality check of the Individual Case Safety Reports, Pharmacovigilance training and compliance. We are 11 competent and dedicated colleagues responsible for Quality and Training activities in Safety Operations. Our daily work demands good co-operation with cross-organisational departments in Global Safety, Global Development/Clinical Operations as well as worldwide affiliates.

The job
As Safety Operations Quality and Training expert you will be responsible for both clinical and post marketing Pharmacovigilance/activities. You main responsibility will be Quality Check (QC) of Individual Case Safety Reports (ICSR), trending and analysis of the data checked, identification of training need, creation of training materials based on the analysis results. The job as Safety Operations Quality & Training expert includes:

Quality Check of the sample of cases and performing the monthly reporting of the data analysed, Correspondence with affiliates and other departments in Headquarters, Contribute to training activities, Ensure all documentation is maintained as required, and advise the need for revision of any SOPs or other departmental documentation, Case handling, Optimization of processes.

Qualifications
You have a relevant medicinal background as a nurse or equivalent. You have experience from pharmaceutical industry, process understanding, very good IT skills including Microsoft Office packages and an excellent command of written and spoken English. You are proactive and you have flair for IT, like to work independently, as well as in a team. You are flexible, have a strong quality mindset and a sense for details, good coordination and planning skills. You are positive with the good sense of humour.

We offer an interesting job with an individually tailored training package with flexible working conditions.

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 Mette-Marie T. Nøigaard +45 3079 4462.

Deadline
23 May 2013]]>Mon, 20 May 2013 00:00:00 GMThttp://www.novonordisk-jobs.com/job/Bagsv%C3%A6rd%2C-Denmark-Safety-Operations-Quality-&-Training-Expert/2607356/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/Bagsv%C3%A6rd%2C-Denmark-Safety-Operations-Quality-&-Training-Expert/2607356/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Title Associate Director-Government Affairs - State Lobbyist (New England)
Job Category Government Affairs
Job Description PURPOSE:
• Conducts the strategic lobbying activities in designated Region, including approximately 12 states. Owns the development, advocacy, communications and execution of key business and triple bottom line legislative initiatives and issue response in the states, both for diabetes and BioPharmaceutical issues.
• Accountable for identifying business risks and developing defensive and responsive strategies to address legislative and public policy initiatives that could also affect patient access to NNI therapies or the ability of the company to develop or market its products.
• In consultation with Managed Markets Accounts executives, initiates strategies to maximize Novo Nordisk’s positioning on state formularies.
• Collaborates with Managed Care executives and field sales staff to implement state strategies that promote the Novo Nordisk brand and/or issues and/or relationships in the States.
• Oversees and directs the activities of contract lobbyists in several states in the region.

RELATIONSHIPS:
• External relationships include: Governors and staff, Legislators and staff, Public Health officials, including the State Health Directors, Diabetes Prevention and Control Programs and other state health agencies. Owns the relationships with various national and regional business, policy and political organizations, such as Governors’ Associations, National Conference of State Legislators, National Black Conference of State Legislators, National Hispanic Conference of State Legislators, and the Council of State Governments. Owns the relationship with the state arms of major trade associations, BIO and PhRMA, and interacts, as necessary, with many other external parties, including physician and patient groups, state diabetes and other health-related coalitions, medical departments of Universities, trade associations, law firms, professional associations, vendors, consultants, contract lobbyists and customers.
• Internal relationships include: Legal, Managed Markets Sales and Strategy, National Changing Diabetes Program, BioPharmaceuticals, Medical, Institutional and DCS Sales, Political Action Committee and NNAS.
• Reports to Director, State Government Affairs
• Provides mentoring, guidance, and counsel to less senior staff.

ESSENTIAL FUNCTIONS:
• Develops and executes strategic action plans on wide variety of public policy and business issues of importance to NNI in the geographic region, including issues affecting diabetes care and biotechnology industry interests
• Advocates with key government officials, legislative committees and other entities the incorporation of Novo Nordisk’s position into state legislative and public policy initiatives of importance to the Company and to patients who rely on NNI therapies.
• Assists in Political Action Committee activities
• Builds, fosters and maintains beneficial relationships with:
-patient, health care professional, and health advocacy groups
- key government officials, legislative committees and other entities that define or influence state policy decisions affecting Novo Nordisk or the patients who rely on our therapies
• Defines contract lobbyist responsibilities and directs activities in order to execute action plans designed to maximize Novo Nordisk's impact on policy makers and patients
• Directs interaction of state health initiatives with Novo Nordisk’s National Changing Diabetes Program initiatives
• Drafts letters, policy statements, and testimony for relevant public officials and entities
• Drafts memos, educational materials, and presentations, as necessary, for the senior Novo Nordisk business and government affairs leadership detailing the impact of government decisions on the company’s business and public policy interests
• Oversees and directs vendor activities for state events
• Plans and executes events for state and local officials designed to increase awareness of Novo Nordisk and diabetes issues and oversees and directs related vendor activities
• Responsible for the effective and efficient use of State Government Affairs annual budget
• Collaborates with Managed Markets, Medical Affairs, Marketing and Sales colleagues to mitigate adverse government decisions and to secure appropriate reimbursement for Novo Nordisk products under federal and state health programs
• Assures strict adherence to lobbying disclosure and other ethical requirements applicable to government relations activities within each state in the region

PHYSICAL REQUIREMENTS:
• Approximately 30% overnight travel

DEVELOPMENT OF PEOPLE:
• Not Applicable

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
• A Bachelor’s degree required; advanced degree preferred
• Lobbying experience, demonstrated ability to effectively deliver information, and explain, advocate and negotiate with a broad spectrum of individuals
• At least 10 years of progressive experience with federal or state legislative, executive and public-policy-making bodies required
• Experience with and understanding of the diabetes therapeutic area preferred
• Experience working with healthcare industry associations, physician or patient groups required, demonstrating an understanding of healthcare and pharmaceutical issues.
• Experience working in a matrixed relationship with sales, managed markets and medical affairs colleagues on public policy matters required
• Results-focused – prior track record required
• Travel required, including travel to NNI’s Princeton office
• Previous supervisory experience preferred
Department HR - GOVERNMENT AFFAIRS (2)
Position Location US - Field Based - Across US
City New England US
State/Provinces US - DC
Degree Required Bachelor's Degree Required
Percent Travel 30 - 40%]]>Thu, 09 May 2013 03:00:00 GMThttp://www.novonordisk-jobs.com/job/Washington-DC-Associate-Director-Government-Affairs-State-Lobbyist-Job-DC-20001/2540835/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.novonordisk-jobs.com/job/Washington-DC-Associate-Director-Government-Affairs-State-Lobbyist-Job-DC-20001/2540835/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS