- Clinical Development Medical Writer
- Remote - West Coast hours required
- Employment Type: 1099 Independent Contractor
BioPhase Solutions is partnering with a leading biotechnology company seeking an experienced Clinical Development Medical Writer to support its growing clinical development programs. We are looking for highly skilled medical writing professionals with extensive experience developing Clinical Study Reports (CSRs), clinical study protocols, and other clinical development documents.
Key Responsibilities
- Independently author, develop, and manage clinical development documents, with a primary focus on Clinical Study Reports (CSRs) and clinical study protocols.
- Collaborate cross-functionally with Clinical Development, Clinical Operations, Biostatistics, and other stakeholders to develop scientifically accurate clinical documents.
- Lead document planning, development, review cycles, and comment resolution meetings to ensure timely completion of deliverables.
- Interpret and synthesize complex clinical trial data, including efficacy and safety results, into clear, concise scientific narratives.
- Facilitate data interpretation and key messaging discussions with cross-functional teams.
- Ensure documents comply with applicable FDA, EMA, and ICH guidelines, internal standards, and established medical writing practices.
- Perform quality control reviews to ensure scientific accuracy, consistency, and completeness.
- Manage multiple writing projects and competing deadlines while maintaining high-quality deliverables.
- Provide medical writing expertise and guidance to clinical development teams.
Qualifications
- Bachelor's degree in a scientific, clinical, or related discipline required; advanced degree preferred.
- 8+ years of medical writing experience within the pharmaceutical or biotechnology industry preferred.
- Demonstrated experience independently authoring CSRs and clinical study protocols is strongly preferred.
- Strong understanding of clinical trial design, clinical development processes, and interpretation of clinical study data.
- Working knowledge of FDA, EMA, and ICH guidelines, particularly ICH E3 and ICH E6.
- Previous experience supporting multiple clinical development programs is a plus.
- Experience with Veeva Vault, Microsoft Office, and medical writing templates is a plus.
Additional Information
- Two consultant openings available.
- 1099 independent contractor engagement.
- Candidates with strong hands-on CSR and protocol writing experience are highly encouraged to apply.
