EPM Scientific is hiring: SR Director Medical Writing, Oncology in San Francisco

KEY RESPONSIBILITIES:

Leadership and Strategy:

• Direct and support the medical writing team by offering mentorship, constructive feedback, and performance evaluations to ensure timely and successful project completion.
• Partner with senior leadership, clinical development, regulatory affairs, and other departments to align medical writing initiatives with broader clinical development strategies.
• Establish and refine writing processes, templates, and best practices to promote consistency, quality, and regulatory compliance.
• Ensure all medical writing activities adhere to relevant regulatory guidelines, industry standards, and internal policies.

Document Development and Review:

• Supervise the creation of critical regulatory and clinical documents, such as clinical trial protocols, investigator brochures, briefing documents, clinical study reports (CSRs), and clinical sections of IND/CTA/NDAs/BLAs.
• Guarantee that medical writing deliverables are completed on schedule and maintain the highest standards of scientific integrity, regulatory accuracy, and quality.
• Oversee and review work produced by team members, including manuscripts, abstracts, posters, and other scientific communications.

Regulatory Submissions and Support:

• Lead the preparation of documents required for regulatory submissions (e.g., IND, NDA, BLA), ensuring alignment with relevant regulations and guidelines (FDA, EMA, ICH).
• Collaborate closely with regulatory affairs teams to refine documents for submission, ensuring clinical data and trial outcomes are presented clearly and accurately.
• Contribute to drafting and reviewing responses to inquiries and comments from regulatory agencies.

Collaboration and Communication:

• Facilitate effective communication with internal and external stakeholders, managing expectations, addressing concerns, and aligning on document timelines and content.
• Provide training and guidance to internal teams on medical writing best practices and collaborative authoring techniques for regulatory documents.

Team Development and Oversight:

• Mentor and support medical writers, fostering their growth and professional development.
• Define performance metrics and key indicators to monitor and ensure the successful completion of medical writing deliverables.
• Cultivate a culture of continuous learning and improvement within the medical writing team.

QUALIFICATIONS:

Education:

• Advanced degree (Ph.D., M.D., or Pharm.D.) in a scientific or medical field preferred. Candidates with a Bachelor's or Master's degree in Life Sciences, Pharmacy, or related disciplines with relevant experience will also be considered.

Experience:

• Minimum of 10 years of medical writing experience in the pharmaceutical or biotechnology sectors, including at least 5 years in a leadership capacity.
• Comprehensive experience drafting regulatory documents for clinical trials across all phases (Phase 1 to Phase 3).
• Proven expertise in preparing regulatory submissions (IND, NDA, BLA) with a strong understanding of relevant guidelines (FDA, EMA, ICH).
• Solid history of team management, mentoring writers, and collaborating effectively with cross-functional groups.

Skills:

• Outstanding written and verbal communication skills, capable of conveying complex scientific concepts clearly and concisely.
• Meticulous attention to detail and a strong commitment to producing high-quality documents.
• Proficient in handling multiple priorities, meeting deadlines, and operating in a fast-paced environment.
• Skilled in using medical writing software and document management systems.
• Effective leadership abilities with a talent for motivating and guiding medical writing teams.