Director, Medical Review and Scientific Communications

Geron Corporation

1d • $220,000 - $240,000

About The Position

The Director of Medical Review and Scientific Communications plays a key role on the Medical Affairs (MAF) team and is responsible for ensuring medical and scientific accuracy of promotional and non-promotional materials in compliance with US laws and regulations, as well as development of medical affairs scientific content and resources. The Director will report to the Executive Director, Medical Capabilities.

Requirements

• Proficiency in CRM systems and technologies for serving as project owner and reviewing medical and promotional materials (e.g., Veeva PromoMats and/or MedComms)
• Understanding of regulatory and legal expectations for promotional and medical materials
• Good negotiation skills
• Excellent written and oral communication skills
• Demonstrated ability to analyze and concisely and accurately summarize complex scientific data to a diverse audience of both scientific and non-scientific professionals in a sound manner
• A commitment to producing high-level results and performing duties with integrity
• Ability to work independently and within a group setting while aligning with company priorities
• 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
• Advanced/doctoral degree in health sciences (PharmD, MD, PhD) required
• A minimum of 7 years of experience in Medical Affairs/Scientific Communications in appropriate functions (e.g., Medical Review, Medical Information, or Scientific Communications)
• 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
• Prior experience reviewing and editing 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
• Experience with project and vendor management, including overseeing content development by medical communications agencies

Nice To Haves

• Experience in malignant hematology or hematology/oncology preferred
• Previous field medical experience preferred

Responsibilities

• In collaboration with Legal and Regulatory Affairs, serve as medical reviewer on Promotional Review Committee (PRC) and Medical Materials Review Committee (MMRC) while ensuring all medical materials are medically accurate, balanced, non-misleading, relevant, and unbiased
• Uphold and improve MMRC and PRC processes (e.g., references are correctly annotated, strength of evidence in reference is appropriate, rationale for comments/requested changes is sufficiently backed, etc.) while reviewing in a timely manner
• Serve as the MMRC coordinator (schedule MMRC meetings and record MMRC decisions) and business administrator
• 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
• Provide feedback to improve review workflows for different material types
• Serve as content lead/owner for development and updating of external and internal medical resources (primarily slide decks for MAF field teams), ensuring scientific accuracy and alignment with strategic imperatives
• Stay up to date on FDA regulations and industry trends relevant to medical and promotional materials development
• Perform other duties and responsibilities as assigned

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree
• Number of Employees: 101-250 employees