genmabMercer County, NJ
Genmab is hiring: Associate Director, Medical Information (Medical Review - Oncology) in Mercer County
Genmab is hiring: Associate Director, Medical Information (Medical Review - Oncology) in Mercer County
Genmab is hiring: Associate Director, Medical Information (Medical Review - Oncology) in Mercer County
genmabMercer County, NJ
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At Genmab, we are dedicated to building extra[not]ordinary® futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines® that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals’ unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees. Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so. Does this inspire you and feel like a fit? Then we would love to have you join us!
Position Summary:
The Associate Director, Medical Information (Oncology) is responsible for the medical review of promotional materials across the life cycle of a product, including launch execution. This role partners closely with Medical Affairs, Commercial, Market Access, Regulatory, Legal, Corporate Communications, and Compliance to ensure materials are medically accurate, balanced, supported by appropriate evidence, and consistent with applicable FDA requirements and guidance. The role requires strong oncology experience, deep scientific expertise and sound judgment, and the ability to provide clear and practical guidance during the review process.
Work arrangement:
This role offers flexibility to work away from the office for 20%–40% of a typical schedule. Employees may use this work schedule in increments of single days or multiple consecutive days, provided it does not exceed 40% within a 60-day period, and is approved by the hiring manager. Domestic and international travel may be required: ~2-3 times per year. Responsibilities will include, but are not limited to, the following: Serve as the medical reviewer for promotional materials, including but not limited to disease-state education, product materials, core visual aids, congress booth materials, training materials, and payer communications as well as patient education materials and patient support services materials. Evaluate materials for medical accuracy, fair balance, clinical relevance, appropriate presentation of data, and consistency with available evidence. Participate in concept reviews to provide recommendations for development of materials. Provide medical guidance during cross-functional review meetings and work with stakeholders to resolve scientific and medical review questions. Conduct and document consistent-with-FDA-required-labeling (CFL) and scientific information for unapproved use (SIUU) analyses which include scientifically appropriate and statistically sound (SASS) assessments. Support launch readiness and execution as a medical reviewer of promotional materials. Maintain current knowledge across relevant oncology therapeutic indications, the broader solid tumor landscape, relevant treatment guidelines, emerging clinical data, and competitor activity. Work with Medical Affairs, Commercial, Market Access, Regulatory, Legal, Corporate Communications, Compliance, and Training to support accurate and consistent product communications. Contribute to medical review operating procedures, training, and process-improvement initiatives. Work with agencies and other external partners involved in content development and review to provide guidance and training on appropriate use of references. Communicate with the Medical Information team to inform on key marketing initiatives. Serve as a preceptor to fellows/students and provide guidance to other members of the Medical Information team. Experience
Also on the board Same function, level within a rung
Level
Manager
Location
Mercer County, NJ
Occupation
Medical Scientists, Except Epidemiologists
Industry
Research and Development in Biotechnology
Posted
today