Associate Director, Medical Writing

ABA Search; South San Francisco (CA); On-site; USD 230,000 - 240,000; Full time

Benefits offered by this job

Annual bonus eligibility

Job summary

ABA Search, Inc. in South San Francisco, CA, is seeking an Associate Director, Medical Writing to lead the creation and review of high-quality clinical and regulatory documents.

The role owns authoring and the approval process for programs, collaborating with clinical science, regulatory, quality, and external partners. The position requires a Master’s degree in life sciences and 8+ years of medical writing experience, with on-site work four days per week.

Qualifications

• Master's degree in life sciences or equivalent required.
• 8+ years of scientific or medical writing experience in biotech/pharma/ CRO.
• Expert knowledge of clinical regulatory document types and guidelines (ICH, FDA, EMA).
• Experience with protocols, CSRs, DSURs, Investigator’s Brochures, and CTD summaries.

Responsibilities

• Provide medical writing leadership for clinical programs and serve as subject matter expert.
• Partner with clinical science to deliver study documents and regulatory submissions.
• Collaborate with regulatory on health authority meeting materials and information requests.
• Lead the review and approval process for clinical and regulatory documents.
• Guide external writers on prioritization, timelines, and process management.
• Develop medical writing best practices, templates, and SOPs with QA alignment.

Skills

Verbal communication

Written communication

Organization

Attention to detail

Project management

Education

Master's degree in life sciences

PharmD or PhD preferred

Tools

Microsoft Office

Adobe Acrobat

SharePoint

Veeva RIM

Job description

Associate Director, Medical Writing South San Francisco, CA | $230,000–$240,000 Bring your medical writing leadership to a pioneering, research-driven biotechnology company where your work will have a direct impact on the quality, compliance, and timeliness of clinical and regulatory documents. This is an opportunity to lead the medical writing function for clinical programs, owning both authoring and the review and approval process for key documents. You'll work closely with clinical science, regulatory, quality, and external partners in a collaborative, start-up style environment that values a positive, can-do team culture. This position is based on-site in South San Francisco at least four days per week.

Why You'll Want to Join

• $230,000–$240,000 annual salary range, based on experience and qualifications
• Annual bonus eligibility
• Opportunity to join an innovative, science-first biotech organization
• Functional leadership and subject matter ownership for medical writing
• Chance to build best practices, templates, and processes
• Broad visibility across clinical science, regulatory, quality, and external partners
• Collaborative environment that values a positive team culture

What You'll Do

As the medical writing lead, you'll guide the creation and review of high-quality clinical and regulatory documents in compliance with applicable guidelines and regulations, while serving as a strong project manager for each deliverable.

• Provide medical writing leadership for clinical programs and serve as the function's subject matter expert
• Partner with the clinical science team to deliver protocols, informed consent forms, clinical study reports, DSURs, Investigator's Brochures, IND clinical summaries, and CTD components such as Module 2 summaries
• Work with the regulatory function on health authority meeting requests, briefing packages, responses to information requests, and other submission documents
• Lead the review and approval process for clinical and regulatory documents
• Guide external writers on prioritization, content, timelines, and process management
• Develop medical writing best practices, including standard timelines, clinical document templates, and style guides
• Partner with Quality Assurance to create and update SOPs for medical writing and clinical documents in line with ICH requirements

What You'll Bring

• Master's degree in a life science discipline from an accredited college or university
• 8+ years of scientific or medical writing experience at a biotech/pharmaceutical company or clinical research organization
• Expert knowledge of standard clinical regulatory document types and requirements (e.g., ICH guidance, FDA, EMA, Health Canada, Asia-Pacific regulations)
• Prior writing experience with Clinical Study Protocols, Clinical Study Reports, DSURs, Investigator's Brochures, IND clinical summaries/overviews, and CTD clinical summaries, plus partnering with external investigators on Investigator Initiated Study Trials
• Expert proficiency with Microsoft Office, Adobe Acrobat, collaborative review systems (e.g., SharePoint), and document management systems (e.g., Veeva RIM)
• Experience with resource planning and managing contractors
• Excellent organization, attention to detail, and verbal and written communication skills, with a self-motivated, collaborative approach
• Ability to roll up your sleeves in a start-up environment with a positive, can-do attitude
• Willingness to work on-site at least four days per week

Especially Helpful:

• A PharmD or PhD is preferred.

Take the Next Step

If you're a medical writing leader who enjoys hands-on authoring, building smart processes, and work that keeps clinical programs moving forward with confidence, this could be an excellent next move.