Description:
We are seeking an exceptional Senior Director, Medical Writing to lead the regulatory and statistical writing function across our client's portfolio, with an immediate focus on their programs. This individual will be a strategic partner to senior leadership, accountable for the execution of high-quality, compliant, and impactful regulatory and scientific documentation that underpins our clinical development and regulatory success.
Key Responsibilities
- Own and deliver the regulatory methodology and statistical writing strategy across all development programs.
- Serve as a strategic subject matter expert on multidisciplinary teams, actively contributing to meetings and authoring key documents.
- Develop and refine internal processes, SOPs, and templates for efficient, compliant, and high-quality document preparation.
- Lead the end-to-end preparation of regulatory documents (e.g., INDs, briefing books, CDPs, nonclinical study reports, submissions, responses to HA questions).
- Design and execute messaging strategies that clearly articulate program rationale, value, and vision to regulatory authorities and internal stakeholders.
- Act as a storytelling architect, synthesizing data into compelling, scientifically accurate narratives aligned with strategic program objectives.
- Provide regulatory and medical writing expertise into product strategy, ensuring alignment between messaging and regulatory goals.
- Collaborate closely with cross-functional teams (Clinical, Safety, Biostats, CMC, etc.) and external partners (CROs, vendors) to ensure consistent, integrated communication.
- Continually evaluate and adopt modern medical writing approaches to maintain a best-in-class writing function.
- Build, mentor, and lead teams (internal and external) to deliver high-caliber outputs.
What You Bring
- B.S. or B.A. in science, pharmacy, or medicine required. Advanced scientific degree preferred. Program Management certification or equivalent is a plus.
- Minimum 10 years in medical writing within the biopharmaceutical industry.
- Proven leadership in regulatory writing for development and submission (e.g., eCTD Modules 2.4/2.6, IBs, briefing docs).
- Demonstrated expertise in cardiovascular, metabolic, or diabetes-related programs strongly preferred.
- Strong understanding of clinical development phases and the associated documentation needs.
- Extensive experience in strategy development and delivering regulatory messaging in a clear, accurate, and persuasive manner.
You’ll be joining a dynamic, mission-driven company where bold thinking is welcomed, collaboration is key, and innovation in service of patient outcomes is celebrated. This is a high-impact role that sits at the heart of our development programs and offers direct visibility with executive leadership.
Compensation & Benefits
- Competitive base salary (exact amount to be discussed based on experience)
- Performance-based bonus
- Equity options (strike price and vesting: cliff + vest 1+3)
- Comprehensive benefits package
- Opportunity to shape and grow a world-class medical writing function