Job Description

JOB DESCRIPTION

SUMMARY:

Fortvita is an emerging bio-pharmaceutical company dedicated to the development of innovative therapies to improve patient outcomes across a wide range of therapeutic areas. The Senior Director, Medical Writing will be responsible for leading the medical writing function across a broad portfolio of clinical development programs, from early-phase clinical trials to Phase 3 studies. This senior leadership role will involve the strategic direction, oversight, and management of all regulatory writing activities, including clinical trial protocols, investigator brochures, briefing books, clinical study reports (CSRs), and other essential documents required for regulatory submissions and scientific communication (e.g DSURs, health authority meeting requests, INDs, etc.). The role requires an individual with excellent leadership skills, a deep understanding of end-to-end oncology clinical development, and the ability to work collaboratively with cross-functional teams, including clinical, regulatory, CMD, clinical pharmacology, biomarker and translational medicine, and clinical operations. This individual should also be able to accommodate changes in timelines based on changes in business priorities or regulatory outcomes and be comfortable working in a fast-paced, small team environment with multiple deliverables across different molecules and tumor indications. Someone who is willing to take on individual projects and deliverables, in addition to the supervisory role is a must. This role will be reporting into the oncology CMO and will have direct reports.

KEY RESPONSIBILITIES:

Leadership and Strategy :

• Lead and manage the medical writing team, providing mentorship, guidance, and performance feedback to ensure the successful execution on time 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 are compliant 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), clinical sections of IND/CTA/NDAs/BLAs, and regulatory submission documents.
• Ensure that medical writing deliverables are completed in a timely manner and meet the highest scientific, regulatory, and quality standards.
• Provide oversight and editing support for direct report responsible for authoring manuscripts, abstracts, posters, and other scientific communications.

Regulatory Submissions and Support :

• Lead medical writing efforts to prepare documents for regulatory submissions (e.g., IND, NDA, BLA) and ensure alignment with regulatory requirements and guidelines (FDA, EMA, ICH).
• Work closely with regulatory affairs to review and refine documents in preparation for regulatory filings, ensuring the 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 and collaborative authoring for medical writing and regulatory documentation.

Team Development and Oversight :

• Lead and mentor a team of medical writers, providing guidance, oversight and support in the development of their skills and careers.
• Establish performance metrics and key performance indicators (KPIs) to ensure 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.

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).
• Demonstrated experience with regulatory submissions (IND, NDA, BLA) and a deep understanding of regulatory requirements and guidelines (FDA, EMA, ICH).
• Proven track record of managing teams, mentoring writers, and working collaboratively with cross-functional teams.

Skills :

• Exceptional written and verbal communication skills, with the ability to communicate complex scientific concepts clearly and effectively.
• Strong attention to detail and commitment to producing high-quality documents.
• Ability to manage multiple priorities, meet deadlines, and work in a fast-paced environment.
• Expertise in medical writing software and document management systems.
• Strong leadership skills and the ability to motivate and guide a team of medical writers.

Job Tags

Similar Jobs