Job Title: Remote: Sr Medical Writer – Protocol Amendment Consultant (237736)
Location: Remote
Duration: 4 weeks, 40 hours total
Start Date: ASAP
JOB SCOPE:
Client is seeking a Senior Medical Writer consultant to lead the drafting and revision of a clinical trial protocol amendment focused on updating the pharmacy/IMP management section.
RESPONSIBILITIES:
- Author and revise the amendment text, covering new dosage calculations, tubing instructions, IMP storage, labeling, dispensing, and accountability requirements.
- Interpret and simplify complex clinical/pharmacy requirements into clear, precise, regulatory-compliant language that site pharmacists and staff can easily follow.
- Engage critically with all content—review, challenge, and identify gaps or ambiguities.
- Meet and collaborate directly with internal pharmacists and clinical staff to validate instructions and ensure they are operationally workable.
- Lead the writing process: ask the right questions, propose practical solutions to issues, and deliver the amendment on time.
- Support editing, review cycles, and version control, ensuring alignment with company templates, style guides, and submission requirements.
- All work relates to CAR-T cell therapy trials for hematologic malignancies (e.g., AML, MDS), but specific disease expertise is less important than familiarity with CAR-T protocols.
- Expected to balance technical precision with user-friendly clarity, ensuring instructions are both scientifically accurate and site-ready.
- Focus on editing, challenging, interpreting, and making sure the final instructions are clear and easy to implement at sites.
IDEAL CANDIDATE WILL HAVE:
- 5+ years of clinical/regulatory medical writing experience.
- Strong track record authoring protocol amendments, especially for pharmacy/IMP sections.
- Experience with CAR-T or other advanced therapy protocols preferred.
- Ability to work independently while collaborating effectively with cross-functional teams.
- Exceptional writing, editing, and critical thinking skills to ensure clear, unambiguous, and compliant documentation.
Remote: Sr Medical Writer – Protocol Amendment Consultant (237736)
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