Medical Writer

About This Role

Lead scientific, medical, and regulatory writing activities for development projects within a pharmaceutical manufacturing and biotechnology research setting. Manage full life-cycle document support from clinical study protocols through regulatory submission and post-approval activities, ensuring compliance with regulations.

Responsibilities

• Manage all clinical writing activities outlined in the Project Clinical Development Plans
• Review documents, offer guidance, and lead in creating and managing document timelines for regulatory and publication documents
• Organize, conduct, and lead document production meetings, creating agendas and minutes according to SOPs
• Manage the oversight of CT.gov updates and directly enter updates into the system when required
• Project Medical Writing assignments, resource allocation, and timeline requirements for Clinical Development Plan (CDP)
• Implement departmental guidelines, writing style guide, and departmental templates (protocols, investigator's brochures, final clinical study reports, IND sections)

Requirements

• Bachelors/Masters degree in a scientific discipline
• 10+ years in pharmaceutical, biotech, or CRO medical writing
• 8+ years writing management experience
• 10+ years previous supervisory experience
• Demonstrated experience as a primary author writing protocols, IBs, CSRs, IND/NDA sections, and other regulated documents
• Knowledge of regulatory functions, FDA and ICH guidelines for various scientific documents
• Knowledge of CTD format
• Experience managing CT.gov and other registries for clinical trials
• Strong analytical and strategic thinking skills
• Ability to create effective presentations from raw data
• Ability to interpret statistical and clinical data
• Ability to work well with others in high-pressure situations
• Demonstrated problem-solving abilities
• Strong organizational skills
• Strong written and verbal communication skills
• Understanding of clinical research, biostatistics, and regulatory affairs
• Excellent computer skills
• Working knowledge of MS Word, Excel, PowerPoint

Qualifications

• Bachelors/Masters degree in a scientific discipline, PhD. in a scientific or life sciences discipline preferred
• Minimum of 10 years in a pharmaceutical, biotech, or CRO medical writing position; 8 years writing management; 10 years supervisory experience

Nice to Have

• PhD. in a scientific or life sciences discipline
• Omnicia template experience
• PleaseReview experience

Skills

* Required skills