Senior Medical Writer
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Catalyst Clinical Research provides customizable solutions to the biopharmaceutical and biotechnology industries through Catalyst Oncology, a full-service oncology CRO,andmulti-therapeutic global functional and CRO services through Catalyst Flex. The company's customer-centric flexible service model, innovative technology, expert team members, and global presence advance clinical studies. Visit CatalystCR.Com. 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. Key Essential Functions
- 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 maintains 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
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