Job Description

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. Critical thinking, diplomacy, and the ability to interact effectively with global key opinion leaders and to proactively suggest improvements to ensure timely document progression. 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.

Clinical Research/Academic Writing Support

• Lead the content planning and production of regulatory documents (clinical development plans, protocols, investigator brochures, clinical study reports, etc.) that align 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).
• Plan and facilitate meetings with cross-functional teams and subject matter experts.
• Participate in quality control (QC) review for documents written by other authors when requested.

Team Support and Mentorship

• Provide mentorship to new/junior writing team members, sharing best practices and suggesting development or learning opportunities as appropriate.
• Support Manager, Medical 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.

Other Writing Support

• Assist with writing or reviewing relevant training materials or work instructions when requested.
• 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.), social media postings, and website content.

Qualifications

• 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

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