Associate Director, Medical Writing Operations

Description of Role

We are seeking an experienced and strategic professional to lead the operational medical writing initiatives across our research and development portfolio. Reporting to the Senior Vice President of Regulatory and Medical Writing, this role combines hands-on medical writing expertise with project management leadership. The Associate Director, Medical Writing Operations will serve as the central point of contact for internal teams and external vendors to ensure consistency, quality, and timely delivery of medical writing outputs while helping to shape the future of our medical writing function.  This position is ideal for a strategic, hands-on professional ready to drive quality, consistency, and operational excellence in a fast-paced environment.

Key Responsibilities 

Project Management and Vendor oversight (75%)

• Serve as the primary point of contact for external medical writing vendors ensuring alignment with company standards, timelines, and expectations, and supporting effective collaboration among writers and reviewers.
• Lead and coordinate medical writing activities across internal SMEs, programs, and external partners, ensuring deliverables are linked to program strategy and remain on track.
• Manage resource planning, including estimating costs and timelines for document preparation. Partner with internal stakeholders to ensure deliverables are on track.
• Ensure medical writing deliverables are scientifically sound, well-organized, and compliant with regulatory and company standards by managing SME contributions and maintaining consistency, accuracy, and quality in a fast-paced, deadline-driven environment.
• Attend clinical study teams, providing strategic input and resolving resource or timeline issues as needed.
• Develop, manage, and continuously improve medical writing procedures, SOPs, and quality frameworks; proactively lead process and system improvements to enhance efficiency and effectiveness within the Centessa medical writing model.

Authorship (15%)

• Review, edit, and ensure the quality, accuracy, and consistency of documents authored by other writers (functional area representatives, or agency or contractors) as required, maintaining compliance with GCP, ICH, eCTD, and company guidelines.
• Provide hands-on support to internal teams by assisting with protocol amendments, clinician responses, and ensuring clarity, consistency, and proper formatting of documents.
• Drive continuous improvement by leveraging industry knowledge to implement new templates, technologies, and processes that enhance medical writing efficiency and effectiveness.
• Author medical writing content, ensuring alignment with company standards, SOPs, style guides, templates, and lexicons.

Strategic Planning (5%)

• Building consistent processes to optimize utilization of resources aligned with company priorities.
• Contribute to long-term planning for potentially transitioning medical writing in-house.

Qualifications

• PhD or advanced degree in a scientific or clinical discipline.
• 8+ years of medical writing or relevant pharmaceutical industry experience, including at least 5 years in sponsor-level clinical/regulatory medical writing. Neuroscience experience is strongly preferred.
• Experience developing and managing project/program teams; demonstrated ability to lead and motivate cross-functional teams.
• Strong organizational, communication, and influencing skills; ability to prioritize, multitask, and deliver high-quality documents under tight timelines.
• Solid understanding of drug development, biostatistics, pharmacokinetics, and medical terminology; basic understanding of scientific methodology as applied to drug development.
• Knowledge of global clinical trials and regulatory submission requirements (FDA, EMA, PMDA), including ICH, GCP, CTD/eCTD, and EU privacy/redaction regulations.
• Proficiency in Microsoft Word (advanced features) and familiarity with document management and collaborative authoring platforms (e.g., Veeva Vault, Please Review).
• Experience managing external medical writing vendors and resolving conflicting editorial feedback.
• Able to work independently and collaboratively in a dynamic, fast paced, cross-functional environment.
• Highly accurate, detail-oriented, and professional, with excellent interpersonal skills and a calm, diplomatic approach to challenges.

Compensation

The annual base salary range for this position is $170,000 to $225,000. Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, and job knowledge.

In addition to base pay, this role is eligible for a discretionary annual bonus and participation in our equity program, allowing you to share in Centessa’s long-term success.

Centessa also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, vision, and life insurance, generous paid time off, and a health and wellness program.

Work Location

The Associate Director, Medical Writing Operations role is a remote role based in the US, with occasional travel.

POSITION: Full-Time, Exempt