Medical Writer

JOB TITLE: Medical Writer

JOB LOCATION: Canada, United States, UK, Germany, the Netherlands or Romania (Home-based)

REPORTS TO: Team Lead, Scientific Writing

DEPARTMENT/UNIT NAME: Medical R&D

JOB SUMMARY:

Provide scientific writing services to Clinical Research Scientists, Academic partners, Sponsors and/or the Corporation, which may include researching, writing, reviewing and editing scientific information, coordinating document reviews with authors, conducting reference searches and verifying citations, translating complex technical research data and findings into academic/scientific publications, regulatory documents (protocols, investigator brochures, clinical study reports, etc.) and presentations on a timely basis that align with industry, regulatory and academic style and content guidelines and standards. Track progress and timeline for assigned writing projects. Perform document quality control review when requested. Provide expertise and guidance to Corporate Business Development, Marketing and Communication specialists when requested assisting with the development promotional materials, website content and/or press releases. Assist with writing or review of relevant training materials or work instruction 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.
•  Work with authors/technical specialists to coordinate the completion of specialized content, to translate, write, edit and/or proof data and content (exhibits, illustrations, tables, and appendices) for publication into finished documents appropriate for the stated audience.
• Regularly track timelines and provide progress reports to stakeholder(s).
• Participate in quality control review for documents written by other authors when requested.

Business Development, Marketing and Communication Support

• Upon request, assist in the development of sales, marketing, and promotional materials.
• Will be required to translate complex scientific information, theories, practices and/or findings into clear, concise, and accurate language that can be understood by potential clients, sponsors and/or the general public.
• Support corporate public relations by providing editing services for conference, industry papers and presentations.

Publication Support

• 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.

Editorial Support

• 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.).

Process Writing

• Assist with writing or review of relevant training materials or work instructions when requested.
  

QUALIFICATIONS:

• Minimum of an undergraduate degree (advanced degrees preferred) and 3-5 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

WORKING CONDITIONS:

 Home-based

*Accommodations for job applicants with disabilities are available

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