Top 10 Medical writer contract Jobs

Director, Regulatory Medical Writing Consultant
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Director, Regulatory Medical Writing Consultant
Kaztronix —Newtown Square, PA
Strong hands-on experience authoring and leading NDA submissions, particularly Module 2 documentation. Support regulatory strategy and document integration for…
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Director, Regulatory Medical Writing Consultant

Kaztronix -
Newtown Square, PA

Quick Apply

Job Details

Contract

Qualifications

Clinical development
Oncology

Full Job Description

Director, Regulatory Medical Writing

Remote | Oncology | NDA Submissions | FDA-Facing Leadership

A growing oncology-focused biopharmaceutical organization is seeking an experienced Director of Regulatory Medical Writing to support late-stage regulatory submission activities for its endometrial cancer program. This is a highly visible, strategic role with the opportunity to evolve into a submission lead position for a critical oncology asset.

The ideal candidate will possess a strong blend of deep clinical foundational knowledge, advanced regulatory writing expertise, and meaningful experience interacting directly with the FDA. This individual will initially partner closely with Regulatory Affairs leadership and will have the opportunity to become the lead writer on the program once they demonstrate strong clinical understanding and effectiveness in regulatory and FDA-facing activities.

Key Responsibilities

Lead the planning, development, and authoring of regulatory submission documents in support of NDA filings
Drive preparation and ownership of key Module 2 documents and summaries
Support regulatory strategy and document integration for oncology programs
Collaborate cross-functionally with Regulatory Affairs, Clinical Development, Biostatistics, Clinical Operations, and related teams
Participate in FDA interactions, regulatory responses, and submission-related communications
Ensure all documents are scientifically accurate, strategically aligned, and compliant with FDA and ICH requirements
Mentor and provide guidance to junior medical writers and CSR-focused writing teams
Contribute to regulatory writing process improvements and best practices

Qualifications

Advanced scientific degree required (PhD, PharmD, MD, or equivalent)
Significant regulatory medical writing experience within biotech, pharma, or CRO environments
Oncology experience required
Strong hands-on experience authoring and leading NDA submissions, particularly Module 2 documentation
Deep clinical foundational experience required
Demonstrated experience with heavy FDA interaction, including submission support, regulatory communications, and agency-facing activities
Ability to independently manage complex writing projects and timelines in a fast-paced environment
Excellent communication, collaboration, and leadership skills

Preferred Experience

Experience mentoring or overseeing junior writers or vendors
Familiarity with oncology indications
Proven ability to operate strategically within cross-functional regulatory teams

Additional Information

Fully remote opportunity
Primarily focused on US regulatory submissions
European submission experience is not required
Open to candidates from CRO environments
Opportunity to grow into a lead regulatory writing role with increased submission ownership and FDA visibility

Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.

By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.

Quick Apply

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