Alimentiv Hiring For Medical Writer (Senior) at Montréal, QC Full Time

JOB TITLE: Medical Writer (Senior)

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

REPORTS TO: Team Lead, Scientific Writing

DEPARTMENT/UNIT NAME: Medical R&D

JOB SUMMARY:

Lead scientific writing projects for Clinical Research Scientists, Sponsors, Academic partners, and/or Alimentiv. Interpret and translate complex technical research data, findings or methodologies into regulatory documents (protocols, investigator brochures, clinical study reports, informed consent forms, etc.) on a timely basis that align with industry, regulatory and academic style and content guidelines and standards. Coordinate document reviews. 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 (grants, study operations, training, communications, etc.) when requested.

ROLE AND RESPONSIBILITIES:

Clinical Research/Academic Writing Support

• Lead the content planning and production of regulatory documents (protocols, investigator brochures, clinical study reports, informed consent forms, safety narratives, IND/CTA submissions, etc.) that aligns with established requirements (HC/FDA/EMA) and best practices (ICH/GCP, 21CFR)
• Interpret and translate complex research findings or design methodologies into regulatory documents.
• Work with sponsors, technical specialists or other collaborators to coordinate the completion of specialized content (figures, tables appendices, etc.) 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

• 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, Scientific Writing or project lead with timeline development and time estimates for writing deliverables.

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. Provide guidance on Common Technical Document (eCTD) requirements.

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 andstudy plans (safety, statistical analysis, etc.).

QUALIFICATIONS:

• Minimum of an undergraduate degree (advanced degrees preferred) and 5-8 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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