Regulatory Medical Writer Consultant

Design Space InPharmatics, a leading international pharmaceutical consulting organization, is seeking an experienced Regulatory Medical Writer to support NDA submission programs for our growing portfolio of drug development clients. We are looking for a consultant with demonstrated expertise authoring and compiling FDA New Drug Application (NDA) submissions, specifically NDA Module 2 and Module 5 content in CTD/eCTD format.

The ideal candidate will bring strong experience in clinical regulatory writing, integrated summaries, clinical study report development, and NDA submission strategy across small molecule and/or biologic drug products. This is a high-impact consulting engagement offering flexibility, and meaningful work at the forefront of regulatory drug development.

Role and Responsibilities

In this high-impact consulting role, the Regulatory Medical Writer will provide expert-level authoring and regulatory documentation support across a range of FDA NDA submission programs. Working remotely within a collaborative consulting team, the successful candidate will:

• Author, edit, and compile NDA Module 2 clinical summaries and overviews, including Clinical Overview (Section 2.5), Clinical Summary (Section 2.7), Benefit-risk assessments and Integrated summaries of safety and efficacy.
• Prepare and/or manage NDA Module 5 clinical documentation, including Clinical study reports (CSRs), Protocols and protocol amendments, Statistical analysis plans (SAPs), Case report tabulations, and listings coordination.
• Ensure all documents comply with FDA guidance requirements, ICH CTD/eCTD standards, Good Clinical Practice (GCP), and internal quality and style standards.
• Participate in submission planning, document gap assessments, and submission readiness reviews.
• Support the preparation of responses to FDA information requests and review comments.
• Coordinate timelines and deliverables to support NDA submission milestones.
• Collaborate cross-functionally with clinical development teams, biostatistics, data management, pharmacovigilance, regulatory affairs, and medical affairs.
• Function as a trusted regulatory writing subject matter expert within client project teams and CMO relationships.
• Proactively flag gaps or risks relative to FDA expectations or industry best practices.

Qualifications and Education Requirements

• Advanced degree preferred (PharmD, PhD, MD, MS, or equivalent scientific discipline), Minimum 8–10 years of pharmaceutical or biotechnology regulatory writing experience.
• Direct, hands-on experience authoring FDA NDA Module 2 and Module 5 content.
• Strong knowledge of FDA NDA submission requirements, ICH E3 and CTD/eCTD structure, clinical trial documentation standards, and drug development processes.

Preferred Skills

• Experience with small molecule drug development programs.
• Demonstrated expertise preparing integrated summaries of safety (ISS) and integrated summaries of efficacy (ISE).
• Familiarity with publishing systems and eCTD submission platforms.
• Prior interaction with FDA review teams or support during regulatory agency meetings.
• Consulting experience supporting multiple sponsors or parallel drug development programs.
• Excellent scientific writing, editing, and data interpretation skills.
• Ability to work independently and manage multiple deliverables in a fast-paced consulting environment.

Additional Notes

• Candidates who bring experience across both small molecule and biologic programs, or who have supported multiple NDA submissions across different therapeutic areas, will be especially well regarded. The responsibilities outlined in this position represent a general summary of the consulting role and are not intended to be all-inclusive. DSI reserves the right to amend this description as client program needs to evolve.
• This is an excellent opportunity for a seasoned regulatory writing professional seeking to apply their expertise within a dynamic, market-leading consulting organization at the forefront of pharmaceutical regulatory strategy and drug development services.
• This is a fully remote, independent consultant role. Consultants are engaged on a project basis and may be assigned to one or multiple concurrent engagements. Hours are not fixed and will fluctuate based on project requirements, milestones, and client needs.
• All applications are reviewed by our human hiring team. No automated screening or AI-based filtering is used to evaluate or eliminate candidates. Every candidate receives personal consideration.