"Alerted.org

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 healthcare 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

The Director Medical Review oversees a team of Medical Reviewers responsible for Medical Assessment of Individual Case Safety Reports and other safety reports pertaining to Novo Nordisk Products. The Medical Review Director is a key Leadership Team member and advisor on Patient Safety Operations including handling of all safety case processing activities for adverse events (AEs) and associated product quality complaints (PQC) for US Operations (USO) post-marketed products from all the sources. The Director is responsible for mentoring coaching and meeting the compliance requirements for the Medical Review Team.

Relationship

Reports directly to Head of PV Case Management. This role involves the oversight of case handling activities across the locations. Collaborate with the other departments within Patient Safety organization, CMR, outside of CMR, and Global Patient Safety and Safety Surveillance teams. Works closely with Promotional Review Board as required.

Essential Functions

+ Leadership & Oversight

+ Lead and manage the Medical Review Case Processing team, fostering a culture of accountability, collaboration, and continuous improvement

+ Provide expert guidance to cross-functional teams regarding safety case management activities

+ Process Development & Optimization

+ Oversees medical review of individual case safety reports for medical content, evaluation of expectedness/listedness and assessment of regulatory status for expedited reporting Design, implement, and continuously improve procedures for AE/SAE case processing from all sources including solicited and unsolicited reports

+ Provide Medical Review Strategy and advise for various case processing activities such as data acquisition, collection, seriousness and coding (drug/event), narrative development, and case assessment

+ Ensure alignment with evolving regulatory requirements and industry best practices. Manage the processing and submission of safety reports including ICSR electronic submissions, IND safety reports and Medical Device Reports, and aggregate reports

+ Local Labelling Committee and Promotional Review Board Advisory

+ Oversees Patient Safety input to all products’ Local Labeling Committees

+ Responsible for ensuring active Patient Safety participation in PRB meetings for all NN products

+ Participate is Suspect Product Committee as delegated

+ Global Coordination

+ Oversees local PSUR and DSUR activities for all products, in collaboration with Managers in Patient Safety and Global teams

+ Oversee communication and workflow integration across case processing hubs (U.S., Mexico City, Bangalore & vendors) and external vendors/contractors

+ Ensure seamless operations and timely delivery of safety data

+ Risk Management

+ Act as the primary point of escalation for Medical Assessment, Provide Medical Advice and Strategy for case-related risks and operational challenges

+ Collaborate with internal stakeholders to proactively identify and mitigate potential issues

+ Compliance & Quality Assurance

+ Partner with NNI Patient Safety Management to ensure timely and accurate processing of safety information in accordance with corporate standards

+ Monitor internal workflows and performance metrics to ensure departmental KPIs and regulatory compliance are consistently met

+ Implement Medical Review Prospective & Retrospective Quality Review of cases

+ Regulatory Intel & Inspection Readiness

+ Maintains up to date knowledge of the regulations and guidelines issued by FDA and ICH as well as other industry sources of information concerning current standards for safety surveillance and FDA reportability

+ Support the preparation and execution of internal and external audits and regulatory inspections

+ Ensure documentation and processes are audit-ready and aligned with global pharmacovigilance standards

Physical Requirements

0-10% travel required.

Development of People

Supervisory. Verbiage below applies only to Supervisory roles; it is removed for individual contributors - DO NOT EDIT. 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

+ MD or equivalent degree required

+ At least 10 years of experience is required, related to Scientific, Regulatory, Pharmaceutical and Medical areas, with at least 6-8 years of experience in pharmacovigilance

+ Supervisory management experience & Leading Therapeutic Areas and teams preferred

+ SME knowledge of global regulations including FDA and ICH regulations and guideline

+ Expertise in safety databases and quality systems

+ Knowledge of NNI supported disease states preferred (e.g., diabetes, obesity, hemophilia, growth hormone disorders)

+ Good communication skills and organizational skills are required

+ Expertise in Workflow, Budgeting and KPI monitoring

Novo Nordisk is currently in the process of adjusting job titles globally. Please note that the job title listed in this advertisement may be subject to change. More detailed information will be provided during the recruitment process.

The base compensation range for this position is $181,670 to $317,920. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance.

Novo Nordisk offers long-term incentive compensation and or company vehicles depending on the position's level or other company factors.

Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy, and parental leave policy.

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

We’re not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health.

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.