Associate Director, Medical Writing — Regulatory Submissions

TSP, a Syneos Health company; Princeton (NJ); On-site; USD 140,000 - 230,000; Full time

Job summary

We are seeking an Associate Director, Medical Writing for a clinical-stage biopharmaceutical company. The role reports to the VP, Regulatory Affairs and serves as the lead medical writer for regulatory submissions and clinical development activities across the US, UK, and EU.

You will author, review, and coordinate high-quality clinical and regulatory documents to support interactions with health authorities, while driving document development in a fast-paced, startup-like environment with

Qualifications

• Advanced degree (MS, PhD, PharmD, or equivalent) in a life sciences discipline.
• 8+ years of medical writing experience within biotechnology, pharmaceutical, or CRO environments.
• Demonstrated experience authoring regulatory submissions and clinical documents for FDA, EMA, and/or MHRA.
• Strong working knowledge of ICH guidelines, GCP, and global regulatory requirements.

Responsibilities

• Lead development of regulatory documents supporting submissions to FDA, EMA, MHRA, and other global regulatory agencies.
• Author or oversee preparation of Clinical Overview and Clinical Summary documents, orphan drug applications, pediatric plans, briefing documents, and responses to health authority questions.
• Partner with Regulatory Affairs to support scientific advice meetings, pre-IND/IND meetings, and interactions with European and UK regulatory authorities.
• Ensure regulatory documents adhere to ICH guidelines, regional regulatory requirements, and current industry standards.
• Support preparation of documents for clinical trial applications (CTAs), regulatory amendments, annual reports, and marketing authorization activities.

Skills

Regulatory writing

Medical writing

ICH guidelines

GCP knowledge

Education

Advanced degree in life sciences (MS/PhD/PharmD)

Tools

Regulatory documents management

Cross-functional collaboration

Job description

We are seeking an Associate Director, Medical Writing for a clinical-stage biopharmaceutical company. The role reports to the VP, Regulatory Affairs and serves as the lead medical writer for regulatory submissions and clinical development activities across the US, UK, and EU.

You will author, review, and coordinate high-quality clinical and regulatory documents to support interactions with health authorities, while driving document development in a fast-paced, startup-like environment with