Medical Information Senior Manager
Position Summary The Medical Information Senior Manager is responsible for managing the Medical Information (MI) function to support business objectives for the Company's first-in-class telomerase inhibitor. The Senior Manager will report to the Executive Director, Medical Capabilities. This position is remote with a corporate headquarters in Foster City, CA and Parsippany, NJ. Primary Responsibilities
- Manage creation and maintenance of accurate and fair-balanced standard response documents (SRD), FAQs, and custom responses to unsolicited external MI requests
- Manage vendor and internal stakeholders to support compliant responses to unsolicited requests for MI, as well as intake and triage of adverse events (AE) and product quality complaints (PQC) case reports
- Author and review US MI responses by identifying and summarizing complex scientific literature in an accurate, fair-balanced, concise, and compliant manner to help inform clinical decision making by healthcare professionals (HCPs)
- Track and report KPIs for inquiry volume, turn-around times, etc.
- Identify data gaps and medical insights to support Company and functional strategic planning
- Provide in-person MI support at medical and scientific congresses, including booth-related activities and materials
- Monitor and maintain bibliography of relevant scientific literature and data on file (DOF)
- Collaborate with Pharmacovigilance & Drug Safety and Quality to ensure streamlined intake and processing of AE and PQC case reports
- Support the medical review process for internal and external medical and commercial materials
- Ensure best practices and full compliance with all regulatory, industry, and Company requirements for MI (e.g., SOP, process documents, workflow)
- Provide scientific and process training to vendors and internal colleagues as needed
- Monitor industry trends and innovations and implement best practices to heighten efficiency, quality, and value of MI
- Manage quality checks of scientific content, including version control, citations, and archiving
- Coordinate scientific and medical review of medical communication materials
- Travel domestically approximately 25% of the time to Company meetings and medical congresses
- Performs other duties and responsibilities as assigned
Competencies
- Current and deep understanding of regulatory and industry guidance, policies, and processes regarding MI and promotional review
- Demonstrated ability in handling complex and/or escalated MI cases
- Excellent written and oral communication skills
- Demonstrated ability to analyze, concisely and accurately summarize, and present complex scientific and medical data
- Possesses a "roll-up-sleeves" and "all-hands-on-deck" mentality
- A commitment to producing high-level results and performing duties with integrity
- Ability to work independently and within a group setting
- Excellent organizational skills
- Familiar with technology solutions routinely used for review of standard response documents and medical materials via various CRM systems (e.g., PromoMats)
Experience
- Advanced/doctoral degree (PharmD, MD, PhD) with at least 3 years of Medical Information or relevant experience
- Experience in malignant hematology or hematology/oncology highly preferred
- Experience in medical writing and scientific content creation (e.g., slide deck development, standard response documents, and AMCP dossier)
- Experience with project and vendor management
EEO Statement: All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. Benefit Statement: All regular-status, full-time employees of Geron are eligible to participate in the Company's comprehensive benefit program, pursuant to plan terms and conditions. Plan choices include medical, dental, vision, life insurance, flexible spending accounts, disability insurance, supplemental health insurance, a 401(k) retirement savings plan, and an employee stock purchase plan. Geron also provides regular-status, full-time employees with a generous time off program that includes the eligibility to accrue 160 hours of vacation during each full year of employment, 64 hours of sick leave, 9 standard paid holiday days off, and paid leave for certain life events. Geron recognizes that its employees work in many different states and therefore may be affected by different laws. It is Geron's intention to comply with all applicable federal, state, and local laws that apply to the Company's employees. Salary Statement: Offered compensation is determined based on market data, internal equity, and an applicant's relevant skills, experience, and educational background. The salary range displayed below are only for those who, if selected for the role, will perform work in the specific locations listed. General Salary Range: $145,000 to $155,000 Apply tot his job Apply To this Job