Senior Medical Writing Lead — Regulatory Submissions

TSP, a Syneos Health company; Baltimore (MD); Presencial; USD 140 000 - 200 000; Tempo integral

Resumo da oferta

TSP, a Syneos Health company, seeks an Associate Director, Medical Writing to lead regulatory and clinical writing across the US, UK and EU. You will author, review, and coordinate high-quality documents to support regulatory submissions and clinical development while ensuring ICH/GCP compliance.

Reporting to the Vice President, Regulatory Affairs, you will drive strategic document development, mentor writers, and partner with cross-functional teams and vendors to interact with FDA, EMA, MHRA

Qualificações

• Advanced degree (MS, PhD, PharmD, or equivalent) in a life sciences discipline.
• 8+ years of medical writing experience within biotechnology, pharmaceutical, or CRO environments.
• Experience authoring regulatory submissions and clinical documents for FDA, EMA, and/or MHRA.
• Strong working knowledge of ICH guidelines, GCP, and global regulatory requirements.
• Proven ability to independently lead complex document projects in a resource-constrained environment.

Responsabilidades

• 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.

Conhecimentos

Regulatory writing

Regulatory submissions

Project leadership

ICH guidelines

Cross-functional collaboration

Formação académica

Advanced degree in life sciences

Descrição da oferta de emprego

TSP, a Syneos Health company, seeks an Associate Director, Medical Writing to lead regulatory and clinical writing across the US, UK and EU. You will author, review, and coordinate high-quality documents to support regulatory submissions and clinical development while ensuring ICH/GCP compliance.

Reporting to the Vice President, Regulatory Affairs, you will drive strategic document development, mentor writers, and partner with cross-functional teams and vendors to interact with FDA, EMA, MHRA