Medical Writing Manager/Senior Manager - Canada

Trilogy Writing & Consulting, a department of Indegene Healthcare Canada, is currently hiring a Medical Writing Manager / Senior Manager to support regulatory documentation for the international pharmaceutical industry. The Senior Manager will report directly to the Director of Medical Writing and play a pivotal role in delivering services that extend beyond writing, with writers integrated into clinical development teams.

Responsibilities include:

• Provide line management of a group of medical writers.
• Provide resource oversight and guidance on a weekly basis.
• Oversee professional development with regular (e.g., quarterly) meetings with all team members.
• Conduct annual and ad-hoc performance reviews for all team members.
• Oversee each employee’s time and utilization.
• Regularly reinforce the company’s values and purpose to maintain shared values, purpose, mission, and vision.
• Participate in Trilogy management-level activities.
• Participate in business development activities such as giving talks or workshops on behalf of Trilogy, participating in management meetings to discuss strategic developments, or representing Trilogy at client meetings.
• Continue writing on client projects but with a reduced writing workload to accommodate management duties.

Required experience and qualifications for this role:

• Experience managing a team of medical writers in a line-management function for a minimum of 2 years.
• A minimum of 8 years of medical regulatory writing experience in a pharmaceutical, biotech, or CRO environment.
• Demonstrated ability and experience as a Lead Medical Writer on multiple regulatory documents/writing projects, including complex, multi-document submissions with global teams (e.g., submission dossiers or responses to regulatory authorities).
• Experience in management and coordination of project-level activities, including oversight of resources, other writers, and QC, and use of systematic methods to plan and coordinate tasks and people.
• Experience with cost/benefit analyses for decision making (e.g., resource assignment, conflict resolution).
• Excellent interpersonal skills with the ability to guide and influence others internally and externally, effective decision-making, and strong written and oral communication skills.

Trilogy offers the following:

• Competitive base salary (starting from CAD $165,000; dependent on experience), subject to company practices.
• Annual bonus opportunity dependent on personal and company performance.
• Generous paid time off (vacation, holiday, illness).
• Comprehensive benefit plans including medical, dental, vision, short- and long-term disability, life insurance with AD&D.
• Retirement savings plan with company match.
• Full AMWA membership and annual conference attendance paid for by Trilogy.
• Continuous personal and professional development opportunities.
• Free weekly yoga sessions.
• Team bonding events and additional activities to support development.

Equal opportunity and data privacy: Indegene is an Equal Opportunity Employer committed to inclusion, diversity, and respect. We do not discriminate on the basis of race, color, religion or belief, sex, sexual orientation, gender identity or expression, age, national or ethnic origin, disability, marital or parental status, or any other characteristic protected by law. All employment decisions are based on business needs, individual merit, and qualifications.

Personal data collected in applications is protected and used solely for employment purposes, with consent and control options described in the policy.

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