Associate Director, Medical Writing - Clinical & Regulatory

Taylor Strategy Partners; Philadelphia (Philadelphia County); On-site; USD 140,000 - 190,000; Full time

Job summary

Taylor Strategy Partners is seeking an Associate Director, Medical Writing to lead regulatory and clinical document development across the US, UK, and EU. The role reports to the VP of Regulatory Affairs and requires hands-on leadership for strategic and operational writing, review, and coordination with cross-functional teams and external vendors.

Ideal candidates bring 8+ years in biotech/pharma medical writing, with proven ability to author regulatory submissions for FDA/EMA/MHRA and to drive

Qualifications

• Advanced degree in life sciences (MS, PhD, PharmD) or equivalent.
• 8+ years medical writing experience in biotech, pharma or CRO.
• Experience authoring regulatory submissions for FDA/EMA/MHRA.

Responsibilities

• Lead development of regulatory documents for FDA, EMA, MHRA and other agencies.
• Author or oversee Clinical Overview and Clinical Summary documents, orphan drug apps, pediatric plans, briefing documents and responses to health authority questions.
• Partner with Regulatory Affairs for meetings and interactions with European and UK regulators.
• Ensure documents adhere to ICH guidelines and regional regulatory requirements.
• Support documents for CTAs, regulatory amendments, annual reports and MAAs.

Skills

Regulatory submissions

ICH/GCP knowledge

Vendor management

Education

MS/PhD/PharmD 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.