Senior Medical Writer
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Job Description
Lead medical writing projects for Clinical Research Scientists and Sponsors, managing complex tasks and ensuring compliance with industry standards. Coordinate reviews and support junior writers while developing timelines.
Responsibilities:
- In this role you will lead medical writing projects for Clinical Research Scientists, Academic partners, Sponsors and/or the Corporation.
- Interpret and translate complex technical research methodologies, data, or messaging into clinical development plans and regulatory documents (protocols, informed consent forms, investigator brochures, clinical study reports, etc.) and/or presentations on a timely basis and in a manner that aligns with industry and regulatory content guidelines and standards.
- Embrace a continuous learning mindset and be able to manage writing projects of high complexity, including those stemming from studies with novel or innovative research designs.
- Coordinate document reviews with authors.
- Develop and track timelines for assigned writing projects.
- Provide mentorship and support to other writing team members.
- Act as primary contact for external publishing if required.
- Assist with review or editing of other materials (training, grants, conference materials, study operational documents, etc.) when requested.
Requirements:
- Minimum of an undergraduate degree (advanced degrees preferred) and 7-9 years of relevant experience in medical writing
- Previous experience with CSRs, IBs, Protocols, and ICFs.
- Trained in GCP, GDPR, and HIPAA
- Expert with EndNote/reference software
- Ability to adapt to shifting priorities and assignments
- Highly refined written and oral communication skills
- Demonstrated ability to work with diplomacy and tact
- Experience working with senior executives and KOLs
- Familiarity with graphical software and figure development
- Previous experience/knowledge of Gastroenterology is an asset
- Familiarity with ICH M11 and the AMA Style Guide is an asset
- Continuous improvement mindset and willingness to embrace new technologies where appropriate
- Experience with INDs, IMPDs, and/or eCTD publishing is an asset
Benefits:
- + bonus
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