http://www.novonordisk-jobs.com/go/Princeton-NJ-Regulatory-Affairs-Jobs/41364/ View Princeton NJ Regulatory Affairs Jobs at Novo Nordisk Fri, 10 Sep 2010 07:09:59 GMT en-us /sites/novonordisk/images/Novo_Banner.gif http://www.novonordisk-jobs.com/go/Princeton-NJ-Regulatory-Affairs-Jobs/41364/ 720 Title Medical Director: Diabetes ? Clinical Development and Research
Job Category Clinical
Job Description Develop, implement and monitor clinical studies (predominantly registration trials from Phase 1 to III) in a team setting. Provide medical and scientific support in other aspects of company activities in the assigned therapeutic area.

RELATIONSHIPS:

Reports to the Executive Director of Diabetes - Clinical Development and Research. Internal relationships include working with Headquarters, the Clinical Trial Management organization, the Biostatistics and Medical Writing departments, the Regulatory Affairs department, and the Medical Affairs and marketing organizations. External relationships include investigators, therapy area experts and other consultants, and key customer groups.

ESSENTIAL FUNCTIONS:

CLINICAL STUDY MANAGEMENT
?Provide regional medical input on the global clinical development plan for assingned clinical development projects within the therapeutic area.
?Represent Clinical, Medical and Regulatory affairs (CMR) organisation in global teams (global project team and/or medical and science teams) and influence strategic project decisions.
?Obtain expert medical community input from US clinical experts..
?Develop or provide regional input to trial outlines and protocols for clinical studies.
?Assist in the selection of investigators for clinical studies.
?Assure timely initiation of studies; act as liaison with Regulatory, project teams, and investigators.
?Monitor conduct of clinical studies, especially medically-related issues, as appropriate.

PROJECT MANAGEMENT LIAISON
?Through the clinical trial unit and project teams, assure timely initiation and completion of studies.
?Assist in developing clinical program time lines, budgets, and strategies.

REGULATORY LIAISON
?Write and/or review clinical sections of clinical/statistical reports, including INDs and NDA.
?Assist in providing medical representation at Regulatory meetings.
?Assist in the interpretation of regulatory guidelines and directives to judge risk and causality

MEDICAL AND SCIENTIFIC SUPPORT FOR OTHER COMPANY ACTIVITIES:
?Medical liaison with the Medical Affairs and departments. Support ongoing sales and marketing objectives by making presentations as appropriate to external groups such as academic and community medical departments (grand rounds), professional associations, and P&T committees.
?Stay abreast of regulatory requirements and guidelines and current trends and medical practice in the field of endocrinology and diabetes, including reports and intelligence on key and critical new technologies or treatment advances.
?Represent NNI in regulatory interactions, investigators? and expert advisory board meetings, external professional societies, seminars, and conventions
?Must maintain necessary credentials and remain in good standing with the medical community and medical ethics boards.

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
?M.D. required, specialist training in endocrinology preferred
?4-6 years experience required - pharmaceutical experience preferred
?Prior clinical research or related experience (e.g. monitoring the conduct of clinical studies and knowledge of Phases I through III.

KEY SUCCESS FACTORS: COMPETENCIES

NNI Leadership Competencies

Lives the Values
Promotes and fosters the Novo Nordisk Values and Way of Management in all business activities. Communicates and role-models the values; sets an example for others to follow. Respectfully and constructively challenges the thinking and actions of others ? regardless of formal authority or if the individual holds a higher position within the company. Adheres to company policies, relevant laws, regulations, and commitments. Maintains a balanced focus on the triple bottom-line: economic viability, environmental sustainability and social responsibility.

Sets Direction and Strategy
Creates and communicates a clear, shared vision for the future consistent with the values and mission of Novo Nordisk. Leads and promotes customer-focused strategies, and ensures strategic imperatives are transformed into actionable business plans. Maintains a balanced perspective between short and long-term priorities. Manages the dynamic tension between stretch goals and realistic plans. Adapts quickly to new situations and changes in the broader healthcare environment.

Fosters Innovation and Continuous Improvement
Quickly assembles information and leverages the diversity of others? experience, backgrounds and expertise when problem solving. Develops new insights and formulates innovative solutions by analyzing, synthesizing and integrating data and information in the context of overall goals and objectives. Encourages and promotes creative problem-solving and breakthrough ideas, development of new systems, programs and processes.

Manages Business Complexity
Makes timely, insightful decisions based on the best information available, and takes effective action incorporating reasoned risk-taking. Establishes and ensures adherence to corporate guidelines and processes within and across functions while maintaining an entrepreneurial spirit. Plans for growth and expansion, and acts as a catalyst for positive, constructive change.

Inspires and Motivates
Communicates with optimism, compassion and sincerity across all levels. Creates energy, excitement and personal investment in others. Instills a sense of urgency, focus, and optimism; even under adversity. Builds a culture of confidence, loyalty and enthusiasm through constant training, development, support, reward, promotion and individual consideration. Demonstrates empathy toward patients and a passion for helping those touched by diabetes or other therapeutic areas where we can make a difference.

Drives Performance
Sets clear and challenging expectations and holds self and others accountable for meeting or exceeding them. Consistently delivers on commitments. Develops and applies new and unique methods and thinking to executing plans and strategies. Continues to drive performance until objectives are met -- does not back down in the face of adversity or obstacles.

Collaborates Across Boundaries
Identifies and eliminates silo thinking, creates company-wide solutions and builds long-term alliances throughout Novo Nordisk. Partners with other departments, functions or businesses to create action plans and achieve business objectives. Seeks multiple perspectives and engages in open and honest two-way communication to consider differing points of view. Consistently develops and sustains cooperative working relationships.

Coaches and Develops People
Develops self and others to accelerate performance in current and future roles. Provides others with candid, timely and constructive feedback. Reinforces, recognizes and rewards positive development in others. Maintains a talent mindset ? consistently considers current team strength and future talent needs relative to business goals and aspirations.

OTHER:
?Works within Novo Nordisk?s established policies and procedures and ensures alignment of their work to Novo Nordisk fundamentals.
?Embraces Novo Nordisk Values in spirit and actions.
Department CMR - CLIN PHARMACOLOGY RESEARCH (2)
Position Location Princeton, NJ
Job/Position State NJ
Degree Required Doctorate Degree Required
Percent Travel 20 - 30%]]> http://www.novonordisk-jobs.com/job/Princeton-Medical-Director-Diabetes-?-Clinical-Development-and-Research-Job-NJ-08540/907904/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS http://www.novonordisk-jobs.com/job/Princeton-Medical-Director-Diabetes-?-Clinical-Development-and-Research-Job-NJ-08540/907904/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Title Senior Manager, Regulatory Affairs (Lead Regulatory Scientist)
Job Category Regulatory Affairs
Job Description Assist senior Regulatory Affairs personnel in assuring compliance. Submit all types of applications to FDA. Provide significant input into development of regulatory strategy documents. Responsible for development of regulatory submission strategies.

RELATIONSHIPS:

Reports to the designated Director or Senior Director, Therapeutic Area. Works with other personnel in the Medical Department and counterparts in NNAS Regulatory Affairs. External relationships include interaction with FDA personnel regarding project issues. Promotes and develops initiatives to continually improve working relationships within and across departments in relation to department and company goals and objectives. Acts as an advisor to subordinates. May supervise or manage junior or more experienced personnel. May lead FDA meetings.

ESSENTIAL FUNCTIONS:

1)SUBMISSIONS:
?Submit all types of applications to FDA.
?Provide significant input into development of comprehensive regulatory strategy documents.
?Facilitate and organize the compilation of applications (IND, NDA, Biologics, Devices) to government agencies in support of research and marketed products. Maintain up-to-date knowledge of the data, information, and formats required for inclusion in these applications.
?Act as liaison with Novo Nordisk and NNAS departments for preparation of documentation necessary for submission of applications.
?Review data from contributing departments (including NNAS) and provide comments to assure accurate and complete documents for inclusion in these applications.
?Supervise and coordinate the planning of FDA submissions for assigned products/projects to ensure most efficient use of resources.
?Approve specified regulatory submissions.

2)FDA COMPLIANCE:
?Provide training to the Sales Reps as needed. Provide information and training for NNAS in areas of IND, NDA, and 501(k) processes.
?Disseminate information on proposed and new FDA regulations and guidelines for assigned products/projects.
?Supervise the review and sign-off on all labeling for marketed products prior to use for assigned products/projects.

3)FDA INTERACTIONS:
?May act as FDA liaison for most project issues.
?Lead FDA meetings.
?Lead label negotiations.
?Participate in and/or coordinate all negotiations and interactions with FDA personnel on projects as assigned.

4)PRODUCT DEVELOPMENT AND SUPPORT:
?Manage moderately complex to complex projects.
?May act as GRT member.
?Coordinate and supervise the development of regulatory strategies for new or modified pharmaceutical products and for 510(k) devices under development or license for assigned projects.
?Supervise all regulatory activities relating to regulatory compliance for assigned marketed and investigational products.
?Supervise and advise staff members.

DEVELOPMENT OF PEOPLE:
?Manage assigned junior to more experienced personnel as direct report.
?Ensure that reporting personnel have 3P forms, as well as own 3P form, 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 development forms are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility.
?Review subordinates 3P and IDP?s.
?Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way of Management.
?Contribute to development of Therapeutic Area Associates and Managers.

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
?Bachelors/Life Science degree required. Advanced degree preferred.
?Minimum 6 years regulatory experience required; 10 years total industry/FDA experience.
?Regulatory project management experience required; supervisory management experience preferred.
?Experience and knowledge of the current requirements of FDA.
?Excellent communication and leadership skills are essential. Ability to establish sound working relationships with different types of people with differing levels of skill and background is essential.
Department CMR - THERAPEUTIC AREA
Position Location Princeton, NJ
Job/Position State NJ
Degree Required Bachelor's Degree Required
Percent Travel 10 - 20%]]> http://www.novonordisk-jobs.com/job/Princeton-Lead-Regulatory-Scientist-Job-NJ-08540/852365/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS http://www.novonordisk-jobs.com/job/Princeton-Lead-Regulatory-Scientist-Job-NJ-08540/852365/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Title Director, Clinical Research-Inflammation
Job Description Develop, implement and monitor Clinical Development Strategy and Clinical Development Plan (CDP) for a drug candidate and then help author and implement clinical studies (registrational Phase II and III trials) in therapies for chronic immune-mediated inflammatory diseases, working in a team setting, where effective interaction with highly skilled colleagues, and with internal and external stakeholders, is critical. Provide medical expertise in the therapeutic area with focus on a specific project and be the internal and external spokesperson for medical aspects of a given therapeutic area Provide medical and scientific support in other aspects of company activities in the assigned therapeutic area.

Member of Global Development Inflammation, the first headquarters' program to be sited in US, in Princeton. Reports directly to the Vice President, Medical & Science- Inflammation in NJ. Internal relationships also include working closely with Headquarters, Clinical Trial Operations, Outcomes Research, Statistics, Regulatory Affairs and Marketing and Sales organizations. External relationships will evolve with the drug candidate's development and will include expert advisory board members, investigators, other consultants, and key customer groups.

CLINICAL STUDY MANAGEMENT
?As chairman of the Medical & Science team, establish the Clinical Development Strategy and CDP of a drug candidate.
?Assume the overall medical responsibility during the execution of the Phase II and III studies described in the CDP
?Provide medical input, and act as the medical expert in the global project team, acting as the driving factor in the cross-organisational implementation of clinical strategies.
?Establish and maintain an external support network including investigators, key opinion leaders, and outstanding research scientists
?Establish relevant external advisory boards, in cooperation with relevant stakeholders
?Develop trial outlines and support the development of complete protocols. Cooperate in the development of other necessary documents, for clinical studies, e.g. IMPDs, CTAs, providing expert medical input throughout.
?Assist in identification and recruitment of investigators for clinical studies.
?Assure timely initiation of studies.
?Act as liaison with Regulatory, project teams, and investigators.
?Manage development of medical aspects of all protocol amendments/ deviations.
?Maintain close collaboration with Clinical Operations personnel involved in studies. Actively monitor clinical studies, providing full and timely support for all medical issues raised in the day-to-day activities of protocols, taking the lead in dealing with all medically related issues, especially adversities.
?Provide high-quality input at meetings and interactions with health authorities and in response to questions posed by health authorities worldwide.
?Generate high-level clinical documents for submission of new drug applications worldwide and experts' reports. Support post-submission activities to achieve regulatory approval and optimal labelling to allow successful launch of the drug
?Provide treatment algorithms if applicable
?Participate in Project core group and/or Global Project Team (GPT)
?Be a member of an asset project team, when appropriate
?Participate in relevant safety committees
?Perform Clinical Lab surveillance and all medical consistency checks
?Provide timely and authoritative medical support to Clinical Research, and cooperate fully with Clinical Research, to ensure appropriate trial execution, evaluation, and reporting

PROJECT MANAGEMENT
?Chair the cross-functional Medical- Scientific team of internal and, if required, external researchers involved in the different phases of drug development
?Through the project development team, assure timely initiation and completion of studies of qualified patients.
?Assist in developing clinical program time lines, budgets, and strategies.
?Provide medical input to, and assist in the updating of, Investigator's Brochure, PBPs and CDPs
?Ensure needed medical content of the individual study reports and publications
?Generate ?story-line? for the clinical part of the submission dossier
?Generate high-level clinical documents for submission of new drug applications worldwide and Experts reports
?Present aspects of the Clinical Development Program of a given project at in- and external meetings
?Provide scientific support to NN Congresses, exhibitions and symposia

REGULATORY
?Write and/or review clinical sections of clinical/statistical reports, including investigator's brochures, INDs Pediatric Investigative Plans and NDA.
?Provide medical input to the design, updating and implementation of NDA database structures.
?Assume overall medical responsibility for the content and quality of the Clinical Part of the Submission Dossier
?Provide medical content of the individual study reports and publications based on results from the clinical development program
?Present medical aspects of the clinical development program at internal and external meetings (including regulatory agencies, congresses, investigator meetings etc.)
?Assist in providing medical representation at Regulatory meetings.
?Assist in the interpretation of regulatory guidelines and directives to judge risk and causality

MEDICAL AND SCIENTIFIC SUPPORT FOR OTHER COMPANY ACTIVITIES:
?Medical liaison with the Marketing/Business Developments. Support ongoing sales and marketing objectives by making presentations, as appropriate, to external groups, e.g. academic and community medical departments (grand rounds), professional associations, and P&T committees.
?Review medical content of company education of sales staff and promotional materials and be part of their educational program.
?Oversee company interactions with the expert community.
?Stay abreast of regulatory requirements and guidelines and current trends and medical practice in the fields of immunology, gastroenterology, and rheumatology, including reports and intelligence on key and critical new technologies or treatment advances.
?Represent NN medical department in regulatory interactions, investigators' and expert advisory board meetings, external professional societies, seminars, and conventions
?Must maintain necessary credentials and remain in good standing with the medical community and medical ethics boards.

EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
?M.D. or D.O. required
?4-6 years pharmaceutical experience preferred, especially with strategy and planning of trials involving monoclonal antibodies or other large proteins.
?Prior clinical research or related experience, e.g. monitoring the conduct of clinical studies and knowledge of Phases I through III.
?Documented clinical expertise in the field of auto-immunity is a definite advantage, especially in inflammatory bowel disease. Prior experience in SLE or rheumatoid arthritis is also very relevant.
?Documented ability to thrive within a matrixed organization
?Ability and willingness to quickly adjust to new situations in a continuously developing environment, in an international organization
?Good teamwork skills; the ability to accept coaching a must
?Fluent in written and spoken English with excellent communication skills.
?Proven presentation skills, with oral and written communication expertise
?High energy, excellent coordination and planning skills, considerable flexibility and a keen sense of quality and purpose.
Department CMR - GD INFLAMMATION (1)
Position Location Princeton, NJ
Job/Position State NJ
Degree Required Doctorate Degree Required
Percent Travel 20 - 30%]]> http://www.novonordisk-jobs.com/job/PRINCETON-Director,-Clinical-Research-Inflammation-Job-NJ-08540/698950/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS http://www.novonordisk-jobs.com/job/PRINCETON-Director,-Clinical-Research-Inflammation-Job-NJ-08540/698950/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Title Associate Director, Regulatory Affairs (Lead Regulatory Scientist)
Job Description Assist senior Regulatory Affairs personnel in assuring compliance. Submit all types of applications to FDA. Provide significant input into development of regulatory strategy documents. Responsible for development of regulatory submission strategies.

RELATIONSHIPS:
Reports to the designated Director or Senior Director, Therapeutic Area. Works with other personnel in the Medical Department and counterparts in NNAS Regulatory Affairs. External relationships include interaction with FDA personnel regarding project issues. Promotes and develops initiatives to continually improve working relationships within and across departments in relation to department and company goals and objectives. Acts as an advisor to subordinates. May supervise or manage junior or more experienced personnel. May lead FDA meetings.

ESSENTIAL FUNCTIONS:

1)SUBMISSIONS:
?Submit all types of applications to FDA.
?Provide significant input into development of comprehensive regulatory strategy documents.
?Facilitate and organize the compilation of applications (IND, NDA, Biologics, Devices) to government agencies in support of research and marketed products. Maintain up-to-date knowledge of the data, information, and formats required for inclusion in these applications.
?Act as liaison with Novo Nordisk and NNAS departments for preparation of documentation necessary for submission of applications.
?Review data from contributing departments (including NNAS) and provide comments to assure accurate and complete documents for inclusion in these applications.
?Supervise and coordinate the planning of FDA submissions for assigned products/projects to ensure most efficient use of resources.
?Approve specified regulatory submissions.

2)FDA COMPLIANCE:
?Provide training to the Sales Reps as needed. Provide information and training for NNAS in areas of IND, NDA, and 501(k) processes.
?Disseminate information on proposed and new FDA regulations and guidelines for assigned products/projects.
?Supervise the review and sign-off on all labeling for marketed products prior to use for assigned products/projects.

3)FDA INTERACTIONS:
?May act as FDA liaison for most project issues.
?Lead FDA meetings.
?Lead label negotiations.
?Participate in and/or coordinate all negotiations and interactions with FDA personnel on projects as assigned.

4)PRODUCT DEVELOPMENT AND SUPPORT:
?Manage moderately complex to complex projects.
?May act as GRT member.
?Coordinate and supervise the development of regulatory strategies for new or modified pharmaceutical products and for 510(k) devices under development or license for assigned projects.
?Supervise all regulatory activities relating to regulatory compliance for assigned marketed and investigational products.
?Supervise and advise staff members.

DEVELOPMENT OF PEOPLE:
?Manage assigned junior to more experienced personnel as direct report.
?Ensure that reporting personnel have 3P forms, as well as own 3P form, 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 development forms are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility.
?Review subordinates 3P and IDP?s.
?Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way of Management.
?Contribute to development of Therapeutic Area Associates and Managers.

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
?Bachelors/Life Science degree required. Advanced degree preferred.
?Minimum 6 years regulatory experience required; 10 years total industry/FDA experience.
?Regulatory project management experience required; supervisory management experience preferred.
?Experience and knowledge of the current requirements of FDA.
?Excellent communication and leadership skills are essential. Ability to establish sound working relationships with different types of people with differing levels of skill and background is essential.
Additional Information Position change form - was aligned to SR Dir (SCTR) - changed to a Lead Regulatory Scientist
Department CMR - THERAPEUTIC AREA (1)
Position Location Princeton, NJ
Job/Position State NJ
Degree Required Bachelor's Degree Required
Percent Travel 10 - 20%]]> http://www.novonordisk-jobs.com/job/PRINCETON-Lead-Regulatory-Scientist-Job-NJ-08540/698960/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS http://www.novonordisk-jobs.com/job/PRINCETON-Lead-Regulatory-Scientist-Job-NJ-08540/698960/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Title Manager of Clinical Quality Support
Job Category Quality
Job Description PURPOSE:

Collaborate with Clinical, Medical and Regulatory (CMR) throughout the North America CDC (NA CDC) in order to establish programs and activities to ensure compliance with GCP regulatory requirements, standards, procedures and global quality objectives. The Quality Specialist (CQS) will serve as the key contact and advisor for teams on primarily GCP/quality issues, and will also advise on GMP and GLP issues as they relate to clinical R&D.

The Quality Specialist CQS will be responsible for maintaining and further developing relations with the NA CDC and Global Development Quality R&D and fostering organizational awareness for continuous improvement.

RELATIONSHIPS:

The position will have a direct reporting relationship to the Associate Director of Clinical Quality Support.

The position will further promote established internal working relationships at all levels within NA CDC (including Canada) CMR: Clinical Trial Operations, Clinical Support Operations, Field Trial Operations, Project Management, Regulatory Affairs, Product Safety, and Medical Affairs. This position will work to develop a positive working relationship with clients at the mid and senior levels management based on accurate assessments SOP/Regulation knowledge and trust.

The position will also promote external relationships which may include interactions with various consultants and organizations as needed.

ESSENTIAL FUNCTIONS:

? Identify NNI liability relative to FDA inspections, product approval, Internal and corporate audits and post audit / inspection follow-up activities.
? Support CQS management in co hosting, coordinating and facilitating NNI FDA inspections
? Identify, diagnose and recommend corrective action for internal client department process inefficiencies as they relate to quality and compliance, as well as areas of noncompliance with SOPs, procedural documents and regulations.
? Present recommendations for corrective and preventive actions as well as process improvements to senior level client management.
? Utilize positive influence techniques to persuade mid and Sr. Management clients to modify department processes to enhance compliance; partner with them to implement action steps.
? Develop and provide training relative to quality, GCP, NN / NNI procedures for internal/external clinical R&D personnel.
? Ensure alignment with Global Quality objectives
? Proactively research local and international GCP regulations and guidelines initiatives, trends and events and communication information to internal clients.
? Consult and advise the efforts relative to internal audit observations and corrective actions
? Acts as a liaison between the HQ Quality and NNI internal client
? Act as a CQS representative at project team, clinical sub-team, and investigator meetings
? Conduct assessments of internal client processes, in order to assess compliance with Novo Nordisk procedures.
? Interact on ongoing basis will all levels of internal client management to provide interpretation of GCP regulations, guidances, policies and procedures
? Participate as a key compliance/quality partner on innovation initiatives, identifying opportunities for process improvements.
? Ensure quality is continually branded throughout the NA CDC.
? Identify potential legal issues and bring it to the attention of legal to be addressed

FDA:
? Work with CQS Management to fulfill inspection requests and coordinate/facilitate FDA/Health Authority inspection activities.
? Manage post-FDA inspection meetings with internal client management to address the potential FDA observations/recommendations.
? Provide guidance to audit action plans to ensure appropriate responses and implementation of corrective activity.

CMR (Clinical, Medical, & Regulatory):
? Identify internal client clinical document insufficiencies and ensure quality control of key clinical trial documents.
? Develop and present educational programs for internal clinical staff members
? Provide support for clinical trial units regarding quality, GCP, protocol, and procedural issues
? Ensure clinical trial related documents are in compliance with company standards and procedures
? Assist CQS Management in communications involving clinical investigator inspections by health authorities
? Assist the internal client in the development of the corrective/preventive action plans to address internal audit findings. Conduct a quality Control review of IC, Protocol/Protocol amendment, Global SOPs

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS

? Bachelors required/Masters preferred; Life Science degree preferred.
? Minimum 5 years Good Clinical Practice experience required: related pharmaceutical experience, including five years Good Clinical Practice auditing activity.
? Minimum 3 years Regulatory/Quality project management experience required; 1 year supervisory management experience preferred.
? Experience and knowledge of the current requirements of FDA and ICH Good Clinical Practices.
? Ability to positively influence and persuade mid and Sr. Management clients into modifying department processes to enhance compliance.
? Excellent communication and leadership skills are essential. Ability to establish sound working relationships with different types of people with differing levels of skill and background is essential.
Additional Information OTHER:
? Works within Novo Nordisk?s established policies and procedures and ensures alignment of their work to Novo Nordisk fundamentals.
? Embraces Novo Nordisk Values in spirit and actions.
? Minimal overnight travel

Nothing in this job description restricts management?s right to assign or reassign duties and responsibilities to this job at any time. Additionally, this job description reflects management?s assignment of essential functions. It does not prescribe or restrict the tasks that may be assigned.
Department LGQ - GCP QUALITY
Position Location Princeton, NJ
Job/Position State NJ
Degree Required Bachelor's Degree Required
Percent Travel 0 - 10%]]> http://www.novonordisk-jobs.com/job/Princeton-Manager-of-Clinical-Quality-Support-Job-NJ-08540/882115/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS http://www.novonordisk-jobs.com/job/Princeton-Manager-of-Clinical-Quality-Support-Job-NJ-08540/882115/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS