Associate Director, Medical Writing - Clinical & Regulatory

TSP, a Syneos Health company; Philadelphia (Philadelphia County); Vor Ort; USD 140.000 - 210.000; Vollzeit

Zusammenfassung

TSP, a Syneos Health company, is seeking an Associate Director, Medical Writing to lead strategic and operational support for regulatory submissions and clinical development activities across the United States, United Kingdom, and EU. The role reports to the VP of Regulatory Affairs and serves as the lead medical writer, coordinating high-quality documents for FDA, EMA, and MHRA.

Ideal candidates will have 8+ years of medical writing experience in biotech/pharma/CRO, an advanced life sciences

Qualifikationen

• Advanced degree in a life sciences discipline (MS/PhD/PharmD or equivalent) required.
• 8+ years of medical writing experience in biotech, pharmaceutical, or CRO environments.
• Proven ability to author/regulatory submissions for FDA/EMA/MHRA and related health authorities.

Aufgaben

• Lead development of regulatory documents for FDA/EMA/MHRA submissions.
• Author or oversee Clinical Overview, Clinical Summary, orphan drug applications, pediatric plans, briefing documents, and responses to health authority questions.
• Collaborate with Regulatory Affairs for meetings with European/UK authorities and cross-functional partners.
• Ensure documents comply with ICH guidelines, regional regulatory requirements, and current industry standards.
• Prepare documents for CTAs, regulatory amendments, annual reports, and MAAs as needed.

Kenntnisse

Regulatory submissions

Medical writing

ICH/GCP knowledge

Leadership

Cross-functional collaboration

Ausbildung

Advanced life sciences degree

Jobbeschreibung

Clinical-stage biopharmaceutical company developing multiple therapeutic products for rare dermatological diseases is seeking a medical writer with an expertise in clinical and regulatory writing to join their team as an Associate Director, Medical Writing. This position will report to the Vice President, Regulatory Affairs serving as the lead medical writer, providing strategic and operational support for regulatory submissions and clinical development activities across the United States, United Kingdom, and European Union. This role will be responsible for authoring, reviewing, and coordinating high-quality clinical and regulatory documents to support interactions with the FDA, MHRA, EMA, and other global health authorities. As a member of a lean biotechnology organization, the successful candidate will be a hand-on contributor who thrives in a fast-paced environment and is comfortable rolling up their sleeves to independently drive document development while partnering closely with cross-functional stakeholders and external vendors.

Primary 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.

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.
• Proven ability to independently lead complex document projects in a resource-constrained environment.

Preferred

• Experience supporting rare disease development programs.
• Experience with Orphan Drug Designation applications in the U.S. and Europe.
• Experience supporting Clinical Trial Applications (CTAs) and Marketing Authorization Applications (MAAs) in Europe.
• Prior experience as the lead or sole medical writer within a startup or emerging biotechnology company.

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