Medical Writing Lead: Clinical & Regulatory Strategy (SF)

ABA Search, Inc.; South San Francisco (CA); In loco; USD 230.000 - 240.000; Tempo pieno

Vantaggi offerti da questo lavoro

Annual bonus eligibility

Descrizione del lavoro

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.

Competenze

• 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.

Mansioni

• 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.

Conoscenze

Verbal communication

Written communication

Organization

Attention to detail

Project management

Formazione

Master's degree in life sciences

PharmD or PhD preferred

Strumenti

Microsoft Office

Adobe Acrobat

SharePoint

Veeva RIM

Descrizione del lavoro

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.