Associate Director, Medical Writing - Clinical & Regulatory

Taylor Strategy Partners; Atlanta (GA); On-site; USD 180,000 - 230,000; Full time

Job summary

Taylor Strategy Partners seeks an Associate Director, Medical Writing to lead regulatory and clinical writing for US, UK, and EU submissions. You will author, review, and coordinate key documents and support interactions with health authorities.

You will report to the VP of Regulatory Affairs, drive cross-functional collaboration, guide vendors, ensure ICH/GCP compliance, and independently manage complex document programs in a fast-paced biotech setting.

Qualifications

• Advanced degree in a life sciences discipline.
• 8+ years of medical writing in biotech/pharma/CRO.
• Experience authoring regulatory submissions for FDA/EMA/MHRA.
• Strong knowledge of ICH guidelines, GCP, and global regulatory requirements.
• Ability to independently lead complex document projects.

Responsibilities

• Lead development of regulatory documents for FDA/EMA/MHRA submissions.
• Author or oversee Clinical Overview, Clinical Summary, orphan drug apps, pediatric plans, and responses to questions.
• Collaborate with Regulatory Affairs for meetings with European/UK authorities.
• Ensure documents comply with ICH guidelines and regional requirements.
• Support CTAs, regulatory amendments, annual reports, and MAAs in relevant regions.

Skills

Regulatory writing

Leadership of documents

Cross-functional collaboration

ICH/GCP knowledge

Strategic thinking

Education

MS/PhD/PharmD or equivalent in life sciences

Job description

Description

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 hands-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 sciencesdiscipline.


• 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.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.