Sr. Medical Writer
- Posted: 12 days ago
JOB TITLE: Sr. Medical Writer
JOB LOCATION: United States
JOB SALARY: 90,000-151,000
REPORTS TO: Team Lead, Scientific Writing
DEPARTMENT/UNIT NAME: Medical R&D
Lead medical writing projects for Clinical Research Scientists, Academic partners, Sponsors and/or the Corporation. Interpret and translate complex technical research data, findings or methodologies into academic/scientific publications, regulatory documents (protocols, investigator brochures, clinical study reports, etc.) and/or presentations on a timely basis that align with industry, regulatory and academic style and content guidelines and standards. Embrace a continuous learning mindset and be able to manage writing projects of increasing 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, communications, sales, grants, study operations, etc.) when requested.
ROLE AND RESPONSIBILITIES:
Clinical Research/Academic Writing Support
- Lead the content planning and production of written research findings (abstracts, manuscripts, systematic reviews, presentations, etc.) or regulatory documents (protocols, investigator brochures, clinical study reports, etc.) that aligns with established standards and guidelines.
- Interpret and translate complex research findings or design methodologies into written publications or regulatory documents.
- Work with authors, technical specialists, or other writers to coordinate the completion of specialized content (exhibits, illustrations, tables, and appendices) for publication into finished documents appropriate for the stated audience.
- Develop document timelines, track, and provide progress reports to stakeholder(s).
- Participate in quality control review for documents written by other authors when requested.
Team Support and Mentorship
- Upon Provide mentorship to new writing team members.
- Share guidance and best practices with writing team members.
- Suggest development or learning opportunities for the writing team.
- Support Manager, Medical Writing or project lead with timeline development and time estimates for writing deliverables.
- Act as primary contact and liaison with external publication executives, illustrators, designers, and editors representing the Scientists/Investigators, Sponsors and/or the corporation with external specialists to select publication content, address content change requests, complete written revisions and/or resolve competing content requirements.
- Upon request, support study teams with review, editing or proof-reading of external grant submissions, study documents or templates, such as charters, informed consent forms, or study plans (safety, statistical analysis, etc.).
Other writing support
- Assist with writing or review of relevant training materials or work instructions when requested.
- Assist with development or editing of sales, marketing, communications, or other promotional materials.
- Upon request, support study teams with review, editing or proof-reading of external grant submissions, study documents or templates, such as charters, informed consent forms, or study plans (safety, statistical analysis, etc.)
- 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.
- Ability to adapt to shifting priorities and assignments
- Highly refined written and oral communication skills
- Demonstrated ability to work with diplomacy and tact
- Previous experience/knowledge of Gastroenterology is an asset
- Familiarity with AMA Style Guide is an asset
- Fluency in English is required as this role requires regular communication in English with clients and staff located in other provinces, the United States, and Europe
Accommodations for persons with disabilities are available on request in respect of all aspects of the recruitment and selection lifecycle. Requests can be directed to firstname.lastname@example.org
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