Senior Director, Medical Writing

This is a fully remote position, open to applicants in United States.

📋 Description

• Author and oversee the creation of clinical study protocols and amendments, clinical study reports, investigator brochures, and other related clinical study documents from initial concept to final product.

• Collaborate with clinical development, biostatistics, and data management for TFL review and case narrative planning.

• Ensure that results and key messages accurately reflect TFLs and other data sources.

• Prepare public disclosure documents, which include postings to clinical trial registries and summaries of results.

• Manage the activities of medical writing vendors and contractors.

• Lead medical writing efforts for IND applications, requests for meetings with health authorities, briefing documents, responses to inquiries from health authorities, and future NDA/MAA clinical modules and submission packages.

• Utilize regulatory writing and data disclosure expertise in submissions.

• Ensure that documents comply with internal processes, are ready for submission, and are archived properly.

• Conduct and coordinate quality control checks, addressing any findings.

• Enhance templates and document preparation processes.

• Act as the primary Medical Writing contact for clinical, regulatory, biostatistics, clinical pharmacology, and translational teams.

• Manage project timelines and document review cycles, clarifying and resolving conflicting or ambiguous feedback.

⛳️ Requirements

• A Bachelor's degree in a life science is required.

• Over 10 years of regulatory medical writing experience within the biotechnology or pharmaceutical sector.

• Experience as the lead author on protocols, clinical study reports, and investigator brochures.

• Proven medical writing experience across various regulatory submissions at different stages of development.

• Strong proficiency in the drug development process.

• Deep understanding of health authority regulations, ICH guidelines, and medical writing standards.

• Ability to apply regulations, guidelines, and standards effectively in document writing.

• Exceptional written and verbal communication skills.

• Ability to summarize complex scientific and clinical data in a concise, accurate, and clear manner.

• Strong project management capabilities.

• Capacity to work independently, manage multiple documents concurrently, and adhere to tight deadlines.

• Collaborative, detail-oriented, and responsive to constructive feedback.

🏝️ Benefits

• Patient Days.

• A culture driven by core values: prioritizing patients, independent thinking, radical transparency, valuing every minute, and letting science lead.

• Decentralized structure that allows program teams to concentrate on advancing science and supporting patients.

• Ownership of program vision and individual career paths.

• A collaborative, fast-paced, and data-driven work environment.

• Access to extensive learning and development resources.

• Comprehensive and competitive compensation and benefits package.

• Health, welfare, and retirement programs.

• Flexible PTO.

• Opportunities for rapid career advancement for high performers.

• Potential to engage in multiple GondolaBio Pharma programs across a variety of therapeutic areas.

• Collaborations with leading institutions.

• A strong commitment to Diversity, Equity & Inclusion.