Director - Medical Promotional Review

About the Department                                                                                                                                               

The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to the same beat is our patient-centered focus. At Novo Nordisk, you will help patients around the world. As their needs evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We’re changing lives for a living. Are you ready to make a difference?

The Position

Lead the Medical Promotional Review staff and direct their activities, across all therapeutic areas where Novo Nordisk Inc. has a presence to ensure scientific accuracy, clinical appropriateness and validity of promotional materials from a medical/scientific standpoint.

Develop and execute the long-term strategy for the Medical Promotional Review team, including solutions for innovation, automation, and optimal resourcing. Serve as an active member of the Promotional Review Board (PRB) and participate in strategic projects the PRB Team considers/initiates.

Manage relationship with key PRB cross-functional stakeholders, especially with Medical Directors, Marketing, Marketing Operations, Legal, Regulatory Affairs and externally with agencies. Represent Medical on PRB Working Group and Steering Committee and provide active input. Oversee collaborations with Medical Affairs to ensure seamless sharing of scientific resources and knowledge related to promotional materials.

Serve as a scientific resource, subject matter expert and mentor to the Medical Promotional Review team in product and disease state areas as well as applicable technology platforms. Develop the Medical Promotional Review Team's capabilities, ensure the team remains up-to-date with Regulatory requirements related to promotional review. Additional responsibilities include input into convention planning/staffing, POA planning/staffing, sales training, product labeling committees and other department projects/initiatives

This role has a critical impact on the business as it greatly affects the appropriateness, validity and scientific accuracy of promotional materials that will be used for internal and external use. This individual can act as head of MI or Scientific Communications if necessary.

Relationships

Reports to head of Scientific Communications. Staff members of the Medical Promotional Review team report to the Director. Works with stakeholders throughout NNI and at external agencies. Key internal relationships include Marketing Operations, Marketing, Legal, Regulatory Affairs, Medical Affairs, Convention Marketing and Sales Training and other key internal cross-functional teams where (s)he provides strategic input.

The Director represents Medical on PRB working group and Steering Committee brand teams/extended brand teams, and product labeling committees.

The Director has an established network of relationships with Promotional Review professionals from other pharmaceutical companies, and Professional Organizations.

Essential Functions

• Applies broad knowledge of Novo Nordisk product information, therapeutic areas and PRB processes to provide oversight to a team of medical reviewers who support promotional review activities across the product portfolio
• Assures team provides high quality critical review of promotional pieces to ensure medical accuracy, validity, and appropriateness of content in accordance with approved labeling, scientific data and relevant laws, regulations and NNI policies to support the safe and effective use of products by patients and the medical community
• Assures team determines appropriateness of data and references used to support promotional claims and marketing messages and providing proactive recommendations and/or guidance for alternative data/references/language where needed
• Assures team reviews, provides comments, and documents verdicts for all assigned promotional materials within PRB workflow system based on assigned deadlines
• Develops and executes the long-term strategy for the Medical Promotional Review team, including solutions for innovation, automation, and optimal resourcing. Identifies new opportunities and leads expansion of the department and roles as needed
• Identifies and pursues new ideas, solutions, methods or opportunities; foster innovation through appropriate risk-taking and experimentation to ensure that the Medical Promotional Review Team uses the most up to date systems and technology
• Represents Medical on PRB working group and Steering Committee and shares key information with team and leadership as appropriate
• Proactively aligns and builds collaborative relationships with key cross-functional stakeholders including other PRB reviewers, commercial team members, and agencies
• Spearheads coordination of activities and information exchange between the Medical Promotional Review team and Medical Information, Medical Affairs, Marketing, Sales, Legal, Regulatory Affairs, etc.
• Ensures adequate resourcing for PRB meetings based on business needs/priorities
• Capable of serving as the medical promotional reviewer for PRB on a consistent or as needed basis
• Ensures team is participating in relevant internal and external meetings and trainings on new guidance/regulations, new scientific information, and marketing strategy
• Remain current with medical literature and data in assigned therapeutic area(s)
• Provides oversight of convention planning/staffing, sales training, product labeling committees and other department projects/initiatives
• Demonstrates the people management skills needed to lead direct reports and working teams; ensures team members have clear direction, necessary resources and are accountable for results
• Ensures that individual development plans are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility
• Ensures that direct reports have performance management forms with annual goals and measurements that are consistent with the priorities of the business
• Primary contact for all Medical Promotional Review related questions and issues
• Establishes working relationships with Promotional Review professionals from other pharmaceutical companies, and Professional Organizations.  Attends, represents NNI and actively participates in relevant conferences to ensure awareness of latest standards and technologies

Physical Requirements

0-10% overnight travel required.

Development of People

Supervisory

Ensure that reporting personnel have individual development plans (IDP), 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.

Qualifications

• Advanced medical degree required (e.g. PharmD, MD); 8+ years of relevant pharmaceutical industry or agency experience required; extensive promotional review experience required
• Thorough understanding of the US pharmaceutical industry and healthcare landscape, promotional review process and relevant guidance and compliance requirements with a focus on medical review
• Demonstrated ability to lead and work within cross functional teams; ability to form effective working relationships within and external to the Medical Promotional Review team
• Previous leadership and people management experience required
• Effective negotiation skills and ability to influence others including senior internal stakeholders
• Strategic thinker with strong problem-solving, organization and prioritization skills
• Ability to identify and implement innovative Promotional Review practices for implementation at Novo Nordisk
• Demonstrated success in driving results based on business need/strategy
• Detail-oriented with demonstrated editorial skills
• Ability to critically analyze and apply scientific data in a customer-focused manner
• Superior verbal and written communication skills
• Prior experience in NNI supported disease states preferred (e.g. diabetes, obesity, hemophilia, growth hormone disorders)

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.