Clinical Medical Writer

Clinical Medical Writer

Malvern, PA (Can start remote than needs to go to the Malvern office)

Perm/Full time

This role is responsible for establishing cross-project consistency in document standards, including the development of protocol frameworks and standardized case report form modules. The Clinical Medical Writer will collaborate closely with Clinical Operations, Regulatory Affairs, Biostatistics, Data Management, and Pharmacovigilance to deliver submission-ready content that is scientifically rigorous and aligned across functions. In addition to execution, this position will support strategic messaging, document quality, and cross-functional integration throughout the clinical development lifecycle.

Responsibilities
• Author, analyze, and integrate technical data (CMC, nonclinical toxicology, and preclinical efficacy) into regulatory documents, including Pre-INDs, INDs, BLAs, DSURs, and IMPDs
• Partner with Regulatory Affairs to prepare and support submissions such as Orphan Drug Designation (ODD), DSUR, and RMAT requests, leveraging preclinical data and disease prevalence insights
• Perform quality control and editorial review to ensure documents meet standards for accuracy, consistency, structure, and clarity
• Support responses to regulatory agency queries and information requests
• Manage document review workflows and approval processes to ensure timely regulatory submissions
• Contribute to the development of scientific presentations, manuscripts, clinical study reports, clinical development programs, abstracts, and publications
• Develop and maintain detailed protocols and guidance documents for clinical and research activities, including support for corporate and scientific presentations
• Drive timelines and coordinate with cross-functional stakeholders to ensure on-time delivery of documents
• Translate complex scientific and clinical data into clear, concise, and well-structured communications for diverse audiences

Qualifications
• PhD with 3+ years of relevant experience, or a Bachelor's/Master's degree in life sciences with 6–10 years of medical or technical writing experience in the biopharmaceutical industry
• Must have experienced in clinical writing, know the clinical documents (protocol, IB,ICF). BLA experience is a plus.
• Direct experience authoring core clinical documents (e.g., protocols, Investigator's Brochures, Informed Consent Forms)
• Demonstrated excellence in scientific writing, with the ability to distill complex data into clear, accurate, and impactful content
• Proven experience collaborating with cross-functional teams, including biostatistics, clinical, regulatory, manufacturing, and quality functions
• Strong understanding of scientific principles, research methodologies, and global regulatory requirements
• In-depth knowledge of the drug development lifecycle and regulatory submission processes; BLA submission experience is a plus
• Experience with biologics and/or gene therapy products is preferred; knowledge of ophthalmology or neuroscience is a plus
• Proficiency in Microsoft Office (Word, PowerPoint) and collaborative authoring platforms (e.g., SharePoint, structured templates)
• Familiarity with illustration/visualization tools and AI tools/platforms is a plus