Director, Lead Regulatory Writer (Remote)

1w1 week ago

PTC Therapeutics, Inc.

US · Full-time · $180,000 – $250,000

About this role

The Director, Lead Regulatory Writer leads, authors, edits and provides input to documents required for regulatory submissions to US and other global health authorities, presentations, posters, publications and regulatory fulfillment. They may author/edit pre-clinical documents and manage a team of direct reports. This role ensures compliance with GCP, regulatory requirements, ICH guidelines, company SOPs and internal style guides.

Daily responsibilities include researching, authoring and editing clinical study reports (CSRs), protocols, protocol amendments, briefing documents, Investigator Brochures (IBs), safety updates and summary modules under strict timelines. Leadership is provided in planning multiple key regulatory submissions like NDAs, MAAs and INDs. Key messages are ensured to be clear and consistent across documents.

Collaboration occurs cross-functionally with departments such as Clinical Development, Regulatory Affairs, Biometrics, PK, Toxicology, Research, Quality and CMC. Oversight of multiple drug programs involves coordinating writing resources and strategic messaging. Consistent document style maintains quality and adherence to company standards.

Proactive improvements in Scientific Writing processes include developing templates. Coaching and mentoring of writers supports submission tasks and internal process enhancements. Serving as subject matter expert at conferences demonstrates PTC’s writing expertise and advances the Medical Writing field.

Requirements

Advanced degree (PhD or PharmD) with 10+ years in medical writing experience in pharmaceutical industry
Or Bachelor’s degree in a scientific discipline with 10+ years of experience in pharmaceutical, biotechnology, or CROs, including participation in submissions
In-depth knowledge of GCP, 21 CFR Parts 312 and 314, EMA Clinical Trials Directives, ICH guidelines
Experience preparing clinical documents such as CSRs, protocols, IBs and briefing documents
Proven leadership in regulatory submissions to US and global health authorities (NDAs, MAAs, INDs)
Ability to manage teams and provide coaching/mentoring to writers
Strong strategic and scientific contribution at project, study team and submission levels

Responsibilities

Lead, author, edit and provide input to regulatory submission documents, presentations, posters, publications and regulatory fulfillment
Work with clinical and regulatory teams to prepare CSRs, protocols, protocol amendments, briefing documents, IBs, safety updates and summary modules
Provide leadership in planning and completing regulatory submissions including NDAs, MAAs, IND submissions and annual reports
Lead and oversee multiple drug programs, coordinating writing resources and contributing strategically to messaging
Collaborate with cross-functional teams (e.g., PK, Toxicology, Research, Clinical Development, Regulatory Affairs, Biometrics, Quality, CMC)
Ensure consistent style of document presentation and adherence to company standards
Manage a team of direct reports and coach/mentor other writers on submission tasks
Serve as subject matter expert at conferences and initiate improvements in Scientific Writing processes