Job Description

Position Overview:

We are seeking a Manager/Senior Manager Medical Writing to lead the development of clinical regulatory documents supporting drug development and regulatory filings. The ideal candidate will have experience in writing and editing key documents like Protocols, Clinical Study Reports, CTD Clinical Overviews and Summaries, ISS/ISE, Investigator Brochures, and Briefing Documents. The position is based in the Eastern Time Zone.

Core Responsibilities:

• Lead and edit clinical regulatory documents, including Protocols, CSRs, CTD Clinical Overviews (M2.5), Clinical Summaries (M2.7.1, M2.7.2, M2.7.3, M2.7.4), ISS/ISE, Investigator Brochures, Briefing Documents, and responses to regulatory authority questions.
• Ensure compliance with global regulatory guidelines and best practices.
• Manage internal teams, vendors, and process improvements for efficient document development.
• Collaborate with cross-functional teams to meet regulatory submission requirements.

Required Qualifications:

• PhD, PharmD, or Master’s degree in Life Sciences or related field.
• PhD/PharmD with 2+ years or Master’s with 4+ years of experience in regulatory medical writing.
• Expertise in global submissions (NDA, BLA, IND, CTA) and clinical document writing (e.g., IB, CRS, ISS/ISE, CTD modules).
• Strong Microsoft Word and document preparation skills.
• Must be located in the Eastern Time Zone.

This position does not offer work visa sponsorship.

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