AbbVie

Senior Manager, Medical Affairs

Employer
AbbVie
Location
Madison, NJ, United States
Posted
Nov 21, 2020
Ref
205321
Required Education
Doctorate/PHD/MD
Position Type
Full time
The Senior Manager, Medical Affairs is a key strategic contributor and leader within USMA. Reporting to the Director, USMA, this role develops and implements a comprehensive medical strategy for each of the products within their respective area of responsibility. They work closely with Medical colleagues in Global Patient Safety & Epidemiology (GPSE), Global Health Economics and Outcomes Research (GHEOR), as well as colleagues within the broader R&D and Commercial organizations. Key deliverables include the development and implementation of the Medical Affairs strategy and tactics for the respective therapeutic area that includes data generation, scientific communications and synthesis of insights. The senior manager will provide medical practice insights to support the clinical development, HEOR, publications, marketing, sales, and regulatory functions to ensure that they are developing product and development strategies that will be relevant to the market - patients, payors and physicians. The Senior Manager, Medical Affairs conducts their work activities in compliance with all internal requirements and with all applicable regional regulatory requirements, which include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements, and objectives.

Qualifications

• Medical degree, PhD, PharmD and/or other higher scientific degree.
• 1+ years biopharmaceutical/medical device industry experience or 3+ years medical communications agency experience, Experience with late phase studies (Phase 3 and 4) would be a plus, as would 1+ years in publications and field-based medical affairs roles. 1+ years of therapeutic area relevant experience required

• Must have a foundational understanding of legal and regulatory guidelines (e.g. knowledge of OPDP promotional regulations, CDER/CBER regulations as they relate to drug approvals).
• Basic understanding of Good Clinical Practices, ICH guidelines, PhRMA code, FDA CFR, ISO, clinical research ethics, HIPAA and patient privacy laws, EU Directive and other applicable local regulations
• Basic understanding of Medical Affairs principles, study design and publications.

Travel
Yes, 25 % of the Time

Job Type
Standard

Schedule
Full-time

Equal Employment Opportunity
At Allergan, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.