SR Director Medical Writing, Oncology Job at EPM Scientific in San Francisco Cou

Job Overview

Leadership and Strategy:

• Lead and manage the medical writing team, providing mentorship, guidance, and performance feedback to ensure the successful execution of all writing projects.
• Collaborate closely with senior leadership, clinical development, regulatory affairs, and other functional departments to align medical writing strategies with overall clinical development goals.
• Develop and implement writing standards, templates, and processes to ensure high-quality, compliant, and consistent document delivery.
• Ensure that medical writing activities comply with regulatory guidelines, industry standards, and internal procedures.

Document Creation and Review:

• Oversee the preparation of key regulatory and clinical documents, including clinical trial protocols, investigator brochures, briefing books, clinical study reports (CSRs), and clinical sections of IND/CTA/NDAs/BLAs.
• Ensure medical writing deliverables are completed on time and meet the highest scientific, regulatory, and quality standards.
• Provide oversight and editing support for team members responsible for authoring manuscripts, abstracts, posters, and other scientific communications.

Regulatory Submissions and Support:

• Lead medical writing efforts for regulatory submissions (e.g., IND, NDA, BLA) and ensure alignment with regulatory requirements and guidelines (FDA, EMA, ICH).
• Partner with regulatory affairs to review and refine documents in preparation for regulatory filings, ensuring accurate presentation of clinical data and trial results.
• Participate in the development and review of responses to regulatory agency questions and comments.

Collaboration and Communication:

• Communicate effectively with internal and external stakeholders to manage expectations, resolve issues, and ensure alignment on document timelines and content.
• Provide training and guidance to internal teams on best practices for medical writing and regulatory documentation.

Team Development and Oversight:

• Lead and mentor a team of medical writers, supporting their development and career growth.
• Establish performance metrics and key performance indicators (KPIs) to track the successful execution of medical writing deliverables.
• Foster a culture of continuous improvement within the medical writing team.

QUALIFICATIONS:

Education:

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

Desired Skills and Experience

Work Experience:

At least 10 years of experience in medical writing within the pharmaceutical or biotechnology industry, with at least 5 years in a leadership role.
Extensive experience writing regulatory documents for clinical trials across all phases (Phase 1 through Phase 3).
Proven experience with regulatory submissions (IND, NDA, BLA) and a strong understanding of regulatory requirements and guidelines (FDA, EMA, ICH).
A track record of managing teams, mentoring writers, and working collaboratively with cross-functional teams.
Required Skills:

Exceptional written and verbal communication skills, with the ability to present complex scientific concepts clearly and effectively.
Strong attention to detail and a commitment to high-quality documentation.
Ability to manage multiple priorities, meet deadlines, and work in a fast-paced environment.
Proficiency in medical writing software and document management systems.
Strong leadership skills with a focus on motivating and guiding a team.