Associate Director, Regulatory and Medical Writer
Ionis Pharmaceuticals, Inc.
August 06, 2026
Remote
United States
Clinical Research and Development
Associate Director - Regulatory and Medical Writing
Responsibilities:
- Lead planning, development, and delivery of complex clinical and regulatory documents for global submissions.
- Author/deliver Module 2 materials (clinical study reports and marketing application summary docs) and lead/contribute to Investigator’s Brochures, clinical study protocols, and briefing documents.
- Serve as Regulatory Medical Writing lead on cross-functional program teams (Clinical Development, Regulatory Affairs, Biostatistics, Safety, etc.).
- Provide strategic input to document planning and submission strategies.
- Lead medical writing for multiple project/core teams; act as subject matter expert for assigned therapeutic/product areas.
- Plan and lead cross-functional teams to meet timelines; lead messaging/storyboarding meetings.
- Manage review cycles, QC reviews, comment resolution, and document-related meetings.
- Coordinate with QA to resolve audit findings; coordinate with Regulatory Operations for on-time document preparation/publication.
- Support regulatory agency information/response requests; mentor medical writers.
Requirements:
- Bachelor’s degree required; advanced degree preferred.
- 12+ years pharmaceutical medical writing including marketing applications (e.g., Module 2.5, 2.7.3, 2.7.4); rare disease experience a plus.
- Proven lead writer experience for CSRs/protocols/IBs/INDs/NDAs/briefing documents; safety sections preferred.
- Lead writer experience for Module 2 summary documents; strong FDA/EMA/ICH knowledge (especially ICH E3 and E6[R3]).
- AMA style proficiency; strong scientific editing/formatting/QC; Microsoft Office, Adobe Acrobat, Veeva; StartingPoint preferred.
- Strong cross-functional leadership, communication, time management, and eCTD/style guide/lexicon experience.
Application:
- Submit via website: http://www.ionis.com (Requisition # IONIS003873).
Compensation:
- Pay scale: $142,588 to $201,472.
Responsibilities:
- Lead planning, development, and delivery of complex clinical and regulatory documents for global submissions.
- Author/deliver Module 2 materials (clinical study reports and marketing application summary docs) and lead/contribute to Investigator’s Brochures, clinical study protocols, and briefing documents.
- Serve as Regulatory Medical Writing lead on cross-functional program teams (Clinical Development, Regulatory Affairs, Biostatistics, Safety, etc.).
- Provide strategic input to document planning and submission strategies.
- Lead medical writing for multiple project/core teams; act as subject matter expert for assigned therapeutic/product areas.
- Plan and lead cross-functional teams to meet timelines; lead messaging/storyboarding meetings.
- Manage review cycles, QC reviews, comment resolution, and document-related meetings.
- Coordinate with QA to resolve audit findings; coordinate with Regulatory Operations for on-time document preparation/publication.
- Support regulatory agency information/response requests; mentor medical writers.
Requirements:
- Bachelor’s degree required; advanced degree preferred.
- 12+ years pharmaceutical medical writing including marketing applications (e.g., Module 2.5, 2.7.3, 2.7.4); rare disease experience a plus.
- Proven lead writer experience for CSRs/protocols/IBs/INDs/NDAs/briefing documents; safety sections preferred.
- Lead writer experience for Module 2 summary documents; strong FDA/EMA/ICH knowledge (especially ICH E3 and E6[R3]).
- AMA style proficiency; strong scientific editing/formatting/QC; Microsoft Office, Adobe Acrobat, Veeva; StartingPoint preferred.
- Strong cross-functional leadership, communication, time management, and eCTD/style guide/lexicon experience.
Application:
- Submit via website: http://www.ionis.com (Requisition # IONIS003873).
Compensation:
- Pay scale: $142,588 to $201,472.