Senior/Principal Medical Writer - Canada

Senior/Principal Medical Writer - Canada

Join to apply for the Senior/Principal Medical Writer - Canada role at Trilogy Writing & Consulting, An Indegene Company

Trilogy Writing & Consulting, an Indegene Company, is hiring Senior/Principal Medical Writers (Canada) to support our growing company in producing regulatory documentation for the international pharmaceutical industry. At Trilogy, you will play a pivotal role in delivering comprehensive services to our clients that extend beyond writing. Our writers are integral members of clinical development teams supporting the writing and coordination of successful documentation across a broad spectrum of therapeutic areas. As our company continues to expand, there is room to develop with us, and your ideas will form our future together. For further insight into who we are and what we do, please explore our website (www.trilogywriting.com). If this excites you, then apply below.
This position is fully remote. Applicants must live in Canada and be authorized to work for any employer in Canada; we are unable to sponsor or take over sponsorship of an employment visa at this time.

Responsibilities

• Prepare a variety of clinical regulatory documents (Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in the CTD format, Investigator Brochures, IMPDs/INDs, scientific publications) as the lead writer in collaboration with client authoring teams and supported by other writers.
• Ensure all documents are produced according to agreed timelines, monitor and manage project budgets, adhere to relevant SOPs, and meet the requirements of Trilogy as well as the company’s clients.
• Provide document-specific advice to clients.
• Oversee and coordinate other writers and QC specialists assisting on documents under your responsibility.
• Project manage the timelines and review cycles of your documents.
• Work in the client’s regulatory document management systems.

Qualifications

• A minimum of a Bachelor’s degree in science/pharmacy (Ph.D. not necessary).
• Fluent written and spoken English skills.
• A minimum of 3-5 years of experience actively writing regulatory documents; experience as a lead writer on CTD documents is required for Principal Medical Writer.
• Must have worked as the lead writer on key regulatory document(s) such as Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in the CTD format, Investigator Brochures, IMPDs/INDs, scientific publications.
• Must be able to manage multiple projects simultaneously.
• Experience interacting directly with clients or authors of the documents and coordinating review cycles, meetings, and project timelines.Must have in-depth working knowledge of the relevant regulatory guidance (e.g. ICH, FDA, EMA) for clinical trial conduct, including document-specific guidance.
• Experience in multiple therapeutic areas is preferred.
• Competency in the use of document management systems and review tools.
• Excellent, proven interpersonal skills, and enjoy proactively participating on a team with diverse personalities.
• Flexibility and the ability to stay focused under tight timelines.

Benefits

• Competitive base salary (range: $121,000 to $163,900 CAD; the salary range is an estimate and may vary based on experience level, region, and the Company’s compensation practices)
• Annual bonus opportunity
• A generous allowance of paid time off (vacation, holiday, birthday, illness)
• Comprehensive benefit plans to include medical, dental, vision, disability, life insurance with AD&D.
• RRSP with company match
• Full AMWA membership and annual conference attendance paid for by Trilogy
• Continuous personal and professional development opportunities
• Free weekly yoga sessions

Equal Opportunity Employer

Trilogy Writing & Consulting, an Indegene Company, is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, candidate’s merit and qualification. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.

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