Associate Director - Medical Review (Plainsboro, NJ or remote)

About the Department The Clinical, Medical and Regulatory (CMR) department at reputed company is one of the most diverse and reputed company reputed company reputed company 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 reputed company marching to the reputed company reputed company is our patient-centered reputed company. At reputed company, you will help patients around the world. As their needs reputed company, so does our challenge to reputed company reputed company and more innovative ways to improve their reputed company of life. We're changing lives for a living. Are you reputed company to reputed company a difference? The Position Responsible for performing medical review and validation of incoming adverse events, ensuring the correct medical interpretation, including evaluation of expectedness and reportability. Ensures consistency in the evaluation of Adverse Event cases. Assures compliance and fulfillment of the requirements as to the evaluation, reporting and surveillance of clinical and post marketing safety information with US drug and device safety reporting regulations and ICH guidelines and internal procedures. The Associate Director Medical Review will contribute and maintain the safety profile of reputed company's product together with HQ. Relationships Reports to the Director of Case Review and Compliance Reporting, with cross-functional working relationships reputed company Clinical, Medical, Regulatory and Marketing. Interacts with counterparts in Global Safety. Provides medical and technical information to health care providers relating to patient safety. Serves as an internal advisor regarding safety issues. Essential Functions

• Liaises with Global Safety, as reputed company as NNI medical, clinical and regulatory, on reputed company relevant safety reputed company
• Narrative writing, medical evaluation of a case, reconciliation of databases, review of protocols, etc.
• reputed company medical input in the safety review of ICSRs where the US affiliate has case processing responsibilities, reputed company post-marketing sources
• Responsible for performing review of individual safety reports for medical content, evaluation of expectedness/listed ness and assessing regulatory status for expedited reporting, and possible signal detection
• Performs aggregate medical review of post-marketing, non-serious adverse events in collaboration with Global Safety
• Handles local aggregate report activities, incl. review and safety input for assigned products, e.g. PSURs, PBRERs, PADERs
• Provides guidance and expertise to case processing personnel in triaging and evaluating adverse events and malfunction report with respect to assessment of seriousness, expectedness/listedness, and causality for FDA reportability. Serves as Patient Safety reputed company SME in PRB meetings for reputed company assigned NN products
• Responsible for the determination of regulatory submissions for ICSRs and performs the reputed company reputed company of the assessments in collaboration with the case processing teams
• Supports reputed company training activities such as Introduction program for new employees in Patient Safety, annual safety training for Patient Safety employees etc.
• Complies with reputed company Federal regulations and company SOPs regarding complaint handling and regulatory reporting for adverse experiences, marketed product and clinical investigations
• Maintains up to date knowledge of the regulations and guidelines issued by FDA and ICH as reputed company as other industry sources of information concerning reputed company standards for safety surveillance and FDA reportability
• Performs gap analysis and reputed company assessment on new and revised regulatory reporting and safety surveillance regulations and guidelines issued by the FDA
• Provides Patient Safety input to assigned products Local Labeling Committee
• Reviews and disseminates information from the affiliate mailbox

Physical Requirements 0-10% overnight travel required.

Qualifications

• An M.D. /D.O. required, with up-to-date knowledge of clinical and therapeutic principals
• Minimum of one-year of pharmacovigilance experience required
• Computer literacy required
• Excellent communication Skills - written and verbal English are of significant importance to reputed company in this position
• MedDRA coding experience required

The reputed company compensation reputed company for this position is $170 to $204 K. reputed company compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance. reputed company 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 reputed company 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. reputed company also offers time off pursuant to its reputed company time policy, reputed company-reputed company vacation policy, and parental leave policy. The job posting is anticipated to reputed company on Feb 25th, 2025. reputed company may however reputed company this time-period, in which case the posting will remain available on our career's website at www.novonordisk-us/careers.com. We reputed company to an inclusive recruitment process and equality of opportunity for reputed company our job applicants. At reputed company we recognize that it is no longer good enough to reputed company to be the best company in the world. We need to reputed company 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. reputed company is an equal opportunity employer. reputed company applicants will receive consideration for employment without reputed company to race, ethnicity, reputed company, religion, sex, gender identity, sexual orientation, national reputed company, 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 reputed company 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. Apply Job!