The Associate Director, Medical Affairs Training & Compliance will work closely with Global Medical Excellence colleagues and with the Medical Affairs Strategy Leadership Team to develop and maintain all Medical Affairs training curricula both in terms of technical as well as soft skills. The candidate in this position will demonstrate a thorough understanding of the medical training needs for both office-based and field-based associates. This role will create an environment of accountability by communicating expectations, timelines and disseminating information for trainings and certifications. The individual will also assist in the development, implementation and management of the Global Medical Affairs compliance program.
The impact this role will have on the organization includes the following:
· Effectively communicate relevant & fair balanced scientific information about Genmab products; seek feedback from FMA (Field Medical Affairs) and GMA (Global Medical Affairs) Leadership to ensure needs are being met; leverage a variety of communication channels to provide training
· New hire global medical affairs onboarding, 90-day training plan/schedule, and their scientific training and certification
· GMA’s continuing education (disease states and scientific data), including treatment landscape training and certification. Utilize MASLs, FMA Leads at discretion as appropriate
· Work closely with FMA, MASLs to determine strategic importance of medical data presented at congresses / medical meetings to create daily highlights and executive summaries for distribution & training
· Work closely with Global Medical Excellence colleagues for business with approved vendors to evaluate the fair market value of all SOW’s related to projects for approval by the Head, Global Medical Affairs
· Working with the Compliance team to develop and roll out training to internal clients, partners, and stakeholders on key compliance policies and procedures
· Reviewing proposed engagements with US healthcare related stakeholders to identify any compliance risk areas and to suggest mitigation strategies, as appropriate; FMV and KOL tiering; Perform necessary analytics for transparency reporting and Aggregate Spend
· Reviewing business materials requiring compliance operational input and advising internal clients, partners, and stakeholders on appropriate strategies, plans and tactics
· Advanced degree (MD, PharmD, PhD,) in medical/biosciences.
· Minimum of 3 years’ experience in training, medical excellence or related and relevant function
· Candidates without an advanced degree are required to have at least 3 years of industry MSL experience in the therapeutic area, and 6 years overall related experience.
· Oncology disease management knowledge required
· Strong broad based scientific and pharmaceutical knowledge, as well as, excellent presentation and teaching skills.
· Strong overall written and verbal communication skills.
· Proven ability to train professionals on soft skills, strategic thinking, and business acumen
· Ability to efficiently manage time and priorities.
· Strong leadership skills and the ability to compile and disseminate information to others in a cohesive fashion to assure a clear understanding of project status and direction.
· Solid understanding of drug development and life-cycle development of a product.
· Ability to motivate and teach team members without a direct reporting relationship.
· Demonstrated ability to think critically, analyze situations and achieve goals.
· Excellent computer skills including power point, word & excel.
· Ability to travel as needed to Conferences and internal meetings, up to 10- 20% of the time