Alexandra Spink - aspink@penfieldsearch.com No 3rd party candidates We are seeking a Senior Regulatory Medical Writer to provide fractional, on-demand support for regulatory submission activities.
Alexandra Spink - aspink@penfieldsearch.com No 3rd party candidates We are seeking a Senior Regulatory Medical Writer to provide fractional, on-demand support for regulatory submission activities.
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In this role, the Senior Medical Writer will be responsible for developing and maintaining key ... This remote position offers the opportunity to collaborate daily with cross-functional partners ...
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In this role, the Senior Medical Writer will be responsible for developing and maintaining key ... This remote position offers the opportunity to collaborate daily with cross-functional partners ...
Senior Medical Writer
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In this role, the Senior Medical Writer will be responsible for developing and maintaining key ... This remote position offers the opportunity to collaborate daily with cross-functional partners ...
Senior Medical Writer
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In this role, the Senior Medical Writer will be responsible for developing and maintaining key ... This remote position offers the opportunity to collaborate daily with cross-functional partners ...
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In this role, the Senior Medical Writer will be responsible for developing and maintaining key ... This remote position offers the opportunity to collaborate daily with cross-functional partners ...
Senior Medical Writer
North Haven, CT · On-site +1
In this role, the Senior Medical Writer will be responsible for developing and maintaining key ... This remote position offers the opportunity to collaborate daily with cross-functional partners ...
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Writer/Journalist Internship: The role is focused on content creation for BORGEN Magazine or The Borgen Project Blog. This is a part-time 12-hours per week, 12 week, unpaid remote internship. If your ...
Writer/Journalist Internship: The role is focused on content creation for BORGEN Magazine or The Borgen Project Blog. This is a part-time 12-hours per week, 12 week, unpaid remote internship. If your ...
Writer/Journalist Internship: The role is focused on content creation for BORGEN Magazine or The Borgen Project Blog. This is a part-time 12-hours per week, 12 week, unpaid remote internship. If your ...
Writer/Journalist Internship: The role is focused on content creation for BORGEN Magazine or The Borgen Project Blog. This is a part-time 12-hours per week, 12 week, unpaid remote internship. If your ...
Writer/Journalist Internship: The role is focused on content creation for BORGEN Magazine or The Borgen Project Blog. This is a part-time 12-hours per week, 12 week, unpaid remote internship. If your ...
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Exceptional written and verbal communication skills, with demonstrated experience in legal content review. * Track record of successful remote collaboration and participation in multidisciplinary ...
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Senior Regulatory Medical Writer - Fractional (Remote)
Fairfield, CT • Remote
Full-time
Re-posted 22 days ago
Job description
Job Description Contact: Alexandra Spink - aspink@penfieldsearch.com No 3rd party candidates We are seeking a Senior Regulatory Medical Writer to provide fractional, on-demand support for regulatory submission activities. This role focuses on independently updating and finalizing regulatory documents to support ongoing agency interactions and submission deliverables, working alongside internal and contract writers. Scope of Work Independently update, revise, and finalize regulatory documents, including protocol and IB Support preparation and maintenance of protocol amendments, submission support documents, and related deliverables within Common Technical Document (CTD Modules 2-5) across the submission lifecycle (responses, amendments, briefing packages) Ensure scientific accuracy, clarity, consistency, and compliance across all regulatory documents Collaborate with internal teams and contract writers to ensure timely delivery aligned with regulatory and quality standards Support intermittent workload demands (~10-15 hours/week during active project periods) Qualifications Regulatory medical writing experience supporting IND, CTA, NDA, and/or BLA submissions Strong familiarity with Common Technical Document (CTD) structure and regulatory submission lifecycle (e.g., responses, amendments, briefing packages) Ability to work independently with minimal oversight in a fast-paced, cross-functional environment Strong attention to detail with demonstrated ability to ensure scientific and regulatory quality standards Proven collaboration experience with regulatory, clinical, and medical writing teams
About Penfield Search Partners
Sourced by ZipRecruiter
Industry
Recruiting and staffing services
Company size
11 - 50 Employees
Headquarters location
Fairfield, CT, US
Year founded
2012