Job Summary:
The Medical Information Manager is a dynamic, experienced medical affairs professional with strong experience working on Medical Legal Regulatory (MLR) and Medical Regulatory Compliance (MRC) committees. The Medical Information Manager will lead and be responsible for the medical review of promotional and scientific exchange materials to ensure medical accuracy and clinical relevance. Additionally, this role will support Medical Information on content development and call center vendor oversight. This position will report to the Director of Medical Information.
Job Responsibilities:
• Represent Medical Affairs on promotional and nonpromotional review committees, and ensure that submitted materials are medically accurate, clinically relevant and supported by appropriate scientific data
• Lead the Medical Review process for the review of scientific exchange materials in partnership with internal stakeholders
• Collaborate with Medical Affairs leadership to ensure promotional and nonpromotional materials are aligned to medical strategy
• Provide medical and scientific expertise to commercial teams to support promotional claims
• Ensure cross-functional communication between Medical Affairs and the MLR committee
• Supports the development and maintenance of Medical Affairs processes and standards related to Scientific Exchange Materials
• Provide support as needed on the development and maintenance of scientific exchange materials including medical response documents
• Provide support on the oversight of the medical information call center vendor
• Complete all work in accordance with regulatory requirements, industry standards, and Evofem policies
• Exhibit broad knowledge of therapeutic areas of interest to Evofem and regulatory guidance
• Attend appropriate medical conferences to learn and evaluate new scientific, product or competitive information, and support the Medical Affairs booth
• As needed, contribute to other ongoing projects within the Medical Affairs organization in collaboration with other members of the Medical Affairs team
Competencies:
• Team oriented and able to effectively partner with internal and external stakeholders/consultants through the development and review of MLR/MRC materials
• Excellent communication skills: verbal and written, with experience in medical writing preferred
• Ability to search and evaluate published scientific literature to create appropriate, balanced responses
• Ability to work effectively and collaboratively cross-functionally
• Ability to handle a variety of tasks and prioritize appropriately
• Ability to influence people without direct authority
• Strong acumen for operational excellence
Supervisory Responsibility:
• No direct people management responsibilities; but may indirectly supervise consultants and/or vendor
Education and Qualifications:
• Advanced degree in health science related field (PharmD, RPh, PhD, MSN, etc.)
• Minimum of 5 years’ experience in the pharmaceutical industry
• Strong working knowledge of FDA regulations regarding drug promotion
• Experience in representing medical on promotional and medical review committees required
• Women’s health experience strongly preferred
• Experience in content management systems preferred
• Agile and flexible as focus and role/responsibility may evolve over time
Travel:
• 5-10% overnight travel may be required