Remote Clinical Medical Writer - Regulatory Submissions

Confidential; Malvern (Chester County); Hybrid; USD 120,000 - 165,000; Full time

Job summary

Confidential in Malvern, PA is seeking a Clinical Medical Writer to establish cross-project document standards and develop protocol frameworks that drive submission-ready content across regulatory functions. This role collaborates across Clinical Operations, Regulatory Affairs, Biostatistics, Data Management and Pharmacovigilance to deliver scientifically rigorous materials.

Ideal candidates will have a PhD with multiple years of medical or technical writing, or a life sciences degree with

Qualifications

• PhD or life sciences degree with substantial writing experience in biopharma.
• Clinical writing experience and familiarity with protocols, IB, and ICF; BLA a plus.
• Experience authoring core clinical documents (protocols, IIBs, and ICFs).
• Strong ability to distill complex data into clear, impactful content.
• Proven cross-functional collaboration with biostatistics, clinical, regulatory, QA, and manufacturing.
• Solid understanding of drug development and global regulatory requirements.
• Knowledge of biologics/gene therapy; ophthalmology or neuroscience knowledge is a plus.
• Proficiency with Word, PowerPoint, and SharePoint; familiarity with AI tools.

Responsibilities

• Author, analyze, and integrate technical data into regulatory documents (CMC, toxicology, preclinical).
• Support submissions and regulatory interactions (ODD, DSUR, RMAT) with Regulatory Affairs.
• Perform quality control to ensure accuracy, consistency, and clarity of documents.
• Assist responses to regulatory inquiries and information requests.
• Manage document review workflows and approval processes to meet deadlines.
• Contribute to scientific presentations, manuscripts, and clinical study reports.
• Develop detailed protocols and guidance for clinical/research activities.
• Drive timelines and coordinate with cross-functional stakeholders for on-time delivery.
• Translate complex data into clear communications for diverse audiences.

Skills

Clinical writing

Regulatory submissions

Cross-functional collaboration

MS Word

PowerPoint

SharePoint

Biopharma knowledge

BLA experience

Education

PhD in life sciences

Bachelor's/Master's in life sciences

Tools

MS Word

PowerPoint

SharePoint

Job description

Confidential in Malvern, PA is seeking a Clinical Medical Writer to establish cross-project document standards and develop protocol frameworks that drive submission-ready content across regulatory functions. This role collaborates across Clinical Operations, Regulatory Affairs, Biostatistics, Data Management and Pharmacovigilance to deliver scientifically rigorous materials.

Ideal candidates will have a PhD with multiple years of medical or technical writing, or a life sciences degree with