Associate Director, Medical Reviewer

Geron

Geron

United States
Posted on Dec 27, 2024

Position Summary

The Associate Director, Medical Reviewer, plays a key role in the Medical Affairs team and is responsible for ensuring medical and scientific accuracy of promotional and non-promotional materials in compliance with US laws and regulations. The position involves reviewing all materials submitted to the Medical Materials Review Committee (MMRC) and Promotional Review Committee (PRC) to ensure regulatory and scientific standards are met, while fostering collaboration with Legal and Regulatory teams to maintain compliance and quality.

Geron has two corporate headquarters in Foster City, CA and Parsippany, NJ. This position is remote, with occasional travel to the corporate office in Parsippany for face-to-face meetings. The Associate Director will report to the Senior Director, Medical Information & Scientific Communications.

Primary Responsibilities

  • Serve as Medical Reviewer in MMRC and PRC, ensuring all medical materials are medically accurate, balanced, non-misleading, relevant, and unbiased, in collaboration with Legal and Regulatory
  • Uphold/improve MMRC/PRC processes (e.g., references are correctly annotated, strength of evidence in reference is appropriate, rationale for comments/requested changes are sufficiently backed)
  • Utilize Veeva PromoMats to review promotional and non-promotional materials in a timely manner
  • Collaborate with project owners to resolve comments and ensure compliance
  • Attend all scheduled MMRC and PRC meetings as required
  • Provide clear guidance to project owners to ensure efficient and appropriate submission of materials through the review process including through weekly office hours as needed
  • Work with the MMRC administrator to optimize review planning and establish the MMRC agenda
  • Provide feedback to improve Veeva PromoMats review workflows for different material types
  • Stay updated on FDA regulations and industry trends relevant to medical and promotional materials development
  • Performs other duties and responsibilities as assigned

Competencies

  • Proficiency in technologies and CRM systems for reviewing medical and promotional materials (e.g., Veeva PromoMats and/or MedComms)
  • Excellent written and oral communication skills
  • Demonstrated ability to analyze, concisely and accurately summarize, and present complex scientific and medical data to a diverse audience of both scientific and non-scientific professionals
  • A commitment to producing high-level results and performing duties with integrity
  • Ability to work independently and within a group setting
  • Excellent organizational skills
  • Must be competent in problem solving and sound decision-making
  • Strong attention to detail and demonstrable ability to identify and correct errors
  • Aptitude for conflict resolution and de-escalation

Experience

  • Advanced/doctoral degree in health sciences (PharmD, MD, PhD) required
  • 7 years of experience as a medical reviewer in appropriate functions (e.g., Medical Affairs, Medical Information, or Scientific Communications)
  • Experience in malignant hematology or hematology/oncology preferred
  • Prior experience reviewing medical materials including Field Medical slide decks, Medical Information response documents and frequently asked questions, medical booth congress materials, congress presentations, scientific communications platforms, clinical pathway submissions, and AMCP dossiers
  • Prior experience reviewing promotional materials including print and digital advertisements (websites, core visual aids, leave behinds, rep triggered emails, etc.), reprint carriers, speaker programs, congress exhibits, sales trainings, and internal comms/field direction memos

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 ranges displayed below are only for those who, if selected for the role, will perform work in the specific locations listed. Please note the employment opportunity is not limited to these locations.

General Salary Range: $175,000 to $190,000