Principal Medical Writer

January 8

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Catalyst Clinical Research

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Catalyst Clinical Research is a specialized clinical research organization with a focus on oncology and multi-therapeutic functional service provision for the global biotechnology and biopharmaceutical industries. Through their Catalyst Oncology division, they offer full-service oncology clinical research support, tapping into an extensive site network and experienced global teams to aid cancer drug development. Meanwhile, Catalyst Flex provides specialized functional solutions across clinical operations, data management, biostatistics, and medical writing to strengthen and customize clinical trials. As a partner in drug development, Catalyst Clinical Research delivers flexible, customizable solutions to meet the diverse needs of biotech companies, emphasizing efficiency and innovation in research.

Clinical Operations Services • Clinical Resourcing/Staffing • Clinical Teams • Functional Service Provider

201 - 500 employees

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

📋 Description

• As a Principal Medical Writer, you will collaborate with members of cross-functional teams to prepare (or oversee preparation by contract service providers) high-quality protocols, protocol amendments, investigator brochures, synopses, Clinical Study Reports, regulatory documents such as INDs and BLAs, clinical publications, and related clinical documents within agreed-upon timelines. • Prepares, edits, and finalizes protocols, investigator brochures, synopses, Clinical Study Reports, pre-IND, IND, NDA submissions, other regulatory documents and related scientific documents, such as abstracts, posters, presentations, and manuscripts, integrating inputs from other team members into a cogent fit-for-purpose whole. • Participates in scientific communication planning, including development of strategic medical communication plans. • Manages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed. • Manages all aspects of outsourced or internal deliverable production and ensures project delivery. • Partners with other clinical team members including participation in the review of mock and/or blinded tables, figures, and listings (TLFs), and narrative planning for relevant documents. • Schedules and conducts document-related meetings including the preparation of pre-meeting agenda, key data points for discussion, and post-meeting minutes. • Collaborates with clinicians, clinical scientists, biostatisticians, and pharmacokineticists to interpret study results and ensure study results and statistical interpretations are accurately and clearly reflected in relevant documents. • Ensures that medical writing deliverables conform to International Conference on Harmonization (ICH) and other relevant regulatory guidelines. • Works closely with QA to maintain standard operating procedures and work instructions for preparation and maintenance of compliant medical writing deliverables. • Ensures that appropriate documented quality control (QC) checks are performed on medical writing deliverables, responds to findings, and recommends quality process improvements. • Showcase flexibility in terms of timelines and writing style based on client needs and/or therapeutic area requirements across various domains. • Conduct client/KOL interactions, kickoff meetings, and teleconferences as needed covering various time zones in an effective manner. • Act as project lead/delivery lead for assigned client and responsible for healthy partnership for each account. • Support proactively in trainings & department operation activities as needed.

🎯 Requirements

• Must have a thorough knowledge of clinical research concepts, practices, and FDA/EMA/other regulations and ICH Guidelines regarding drug development phases, clinical research and medical writing standards; demonstrated ability to interpret and apply these guidelines to document writing. • Broad experience managing the medical writing responsibilities associated with multiple studies at various stages and across various functional teams. • Ability to work independently with minimal supervision, multi-task, and work effectively under pressure in a virtual R&D organization; adapt to change as needed; possess excellent project management skills; attentive to details. • Ability to communicate with teams to set realistic timeline expectations; demonstrated ability to deliver within agreed internal and regulatory timelines; monitor and communicate progress against milestones; escalate complex issues appropriately. • Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members. • Ability to communicate scientific or medical information in a clear and concise manner. • Track record of increasing responsibility and independence in a similar role in pharmaceutical drug development. • Excellent organization skills with acute attention to detail. • Strong computer skills, including use of EndNote/ equivalent software within MS Word and other tools for MW activities.