Senior Medical Writer
3 weeks ago
Senior Medical Writer (remote) Altasciences is a leading company dedicated to the discovery, development, and manufacturing of new drug therapies, delivering high‑impact solutions across the globe. The remote Senior Medical Writer will contribute to clinical research documentation and support sponsors’ clinical programs. About The Role The Senior Medical Writer is responsible for gathering and synthesizing information to produce high‑quality clinical research documents that support the execution and reporting of sponsors’ clinical research programs. Responsibilities Serve as the Medical Writing representative on assigned project teams. Develop clinical protocols for Phase 1–2a studies. Review and provide feedback on client‑provided protocols. Contribute to risk assessment and management plans (RAMPs) for assigned studies. Review case report forms (CRFs) and statistical analysis plans (SAPs) to ensure completeness and accuracy. Create clinical study reports (CSRs), standalone safety narratives, and integrated safety summaries. Analyze and interpret safety and pharmacodynamic results. Prepare and review CSR appendices per ICH E3 guidance. Assist with deficiency letters from regulatory agencies. Perform literature searches/reviews for background information. Coordinate internal review and manage incorporation of external feedback. Perform quality control and editorial review of documents. Participate in internal and external project meetings. Coordinate with team to deliver documents on agreed timelines. Ensure compliance with SOPs, GCP, and regulatory guidelines. Maintain familiarity with regulatory guidelines and ICH/GCP procedures. Participate in quality improvement initiatives. Support training of Medical Writers and Associates. Assist in coordination of team workload. Maintain and participate in departmental objectives. Qualifications Master’s Degree in health‑related sciences or a related field (advanced degree preferred). Experience in medical writing for clinical research. Excellent verbal and written communication skills. Ability to acquire and apply knowledge quickly. Professional attitude and strong interpersonal skills. Ability to work well with a multidisciplinary team of professionals. Client‑focused approach to work. Flexible attitude toward work assignments and new learning. Ability to prioritize workload. Superior attention to detail. Understanding of clinical research, drug development process, and applicable regulatory guidelines. Strong computer skills (Microsoft Word, Excel, PowerPoint) and adaptability to IT systems. Fluency in English is essential; French proficiency is an asset but not mandatory. What We Offer Health/dental/vision insurance plans. 401(k)/RRSP with employer match. Paid vacation and holidays. Paid sick and bereavement leave. Employee assistance & telehealth programs. Training & development programs. Employee referral bonus program. Annual performance review. Altasciences is an equal‑opportunity employer committed to diversity and inclusion. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability or any other protected ground under applicable legislation. Reasonable accommodations for persons with disabilities during the recruitment process are available upon request. Seniority level: Mid‑Senior; Employment type: Full‑time; Job function: Marketing, Public Relations, and Writing/Editing; Industry: Research Services. #J-18808-Ljbffr
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Senior Medical Writer
3 weeks ago
Laval, Toronto, Montreal, Calgary, Vancouver, Edmonton, Old Toronto, Ottawa, Mississauga, Quebec, Winnipeg, Halifax, Saskatoon, Burnaby, Hamilton, Victoria, Surrey, London, Halton Hills, Regina, Markham, Brampton, Vaughan, Kelowna, Southwestern Ontario, R, Canada Altasciences Full timeSenior Medical Writer (remote) Altasciences is a leading company dedicated to the discovery, development, and manufacturing of new drug therapies, delivering high‑impact solutions across the globe. The remote Senior Medical Writer will contribute to clinical research documentation and support sponsors’ clinical programs. About The Role The Senior Medical...
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Toronto, Montreal, Calgary, Vancouver, Edmonton, Old Toronto, Ottawa, Mississauga, Quebec, Winnipeg, Halifax, Saskatoon, Burnaby, Hamilton, Surrey, Victoria, London, Halton Hills, Regina, Markham, Brampton, Vaughan, Kelowna, Laval, Southwestern Ontario, R, Canada Nucleus Global Full timeCompany OverviewNucleus Global, an Inizio company, is an international medical communications agency known for delivering high‑quality, creative communication solutions. With 14 offices spanning the US, Europe and Asia Pacific, we integrate scientific expertise, strategic insight and dedicated talent to provide an unrivalled approach to medical...
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Toronto, Montreal, Calgary, Vancouver, Edmonton, Old Toronto, Ottawa, Mississauga, Quebec, Winnipeg, Halifax, Saskatoon, Burnaby, Hamilton, Surrey, Victoria, London, Halton Hills, Regina, Markham, Brampton, Vaughan, Kelowna, Laval, Southwestern Ontario, R, Canada Inizio Engage XD Full timeJoin to apply for the Medical Writer role at Inizio Engage XD. We are looking for a Medical Writer to join our team. You will create accurate, engaging, well‑written referenced scientific content for a variety of life sciences training deliverables (e.g., self‑study curricula assets, workshops) and represent the scientific team on assigned projects. You...
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Senior Medical Writer – Remote Canada
3 weeks ago
Burlington, Toronto, Montreal, Calgary, Vancouver, Edmonton, Old Toronto, Ottawa, Mississauga, Quebec, Winnipeg, Halifax, Saskatoon, Burnaby, Hamilton, Victoria, Surrey, Halton Hills, London, Regina, Markham, Brampton, Vaughan, Kelowna, Laval, Southwester, Canada ICON Full timeA leading healthcare organization in Canada is seeking a Senior Medical Writer to develop and execute medical writing strategies for clinical research projects. This role involves preparing clinical documents, collaborating with teams, and mentoring junior writers. Candidates should have a strong background in life sciences and experience in medical writing....
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Sr Medical Writer
4 weeks ago
Burlington, Toronto, Montreal, Calgary, Vancouver, Edmonton, Old Toronto, Ottawa, Mississauga, Quebec, Winnipeg, Halifax, Saskatoon, Burnaby, Hamilton, Victoria, Surrey, Halton Hills, London, Regina, Markham, Brampton, Vaughan, Kelowna, Laval, Southwester, Canada ICON Full timeOverview Sr. Medical Writer - Remote Canada ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Senior Medical Writer to...
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Toronto, Montreal, Calgary, Vancouver, Edmonton, Old Toronto, Ottawa, Mississauga, Quebec, Winnipeg, Halifax, Saskatoon, Burnaby, Hamilton, Surrey, Victoria, London, Halton Hills, Regina, Markham, Brampton, Vaughan, Kelowna, Laval, Southwestern Ontario, R, Canada Nucleus Global Full timeA leading medical communications agency in Canada is seeking a Senior Medical Writer to develop innovative scientific content for various projects. This role involves translating complex research data into clear communication for clients in the pharmaceutical and biotechnology sectors. The ideal candidate will hold an advanced degree in a life science...
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Toronto, Montreal, Calgary, Vancouver, Edmonton, Old Toronto, Ottawa, Mississauga, Quebec, Winnipeg, Halifax, Saskatoon, Burnaby, Hamilton, Victoria, Surrey, London, Halton Hills, Regina, Markham, Brampton, Vaughan, Kelowna, Laval, Southwestern Ontario, R, Canada Everest Clinical Research Services Inc. Full timeA leading Canadian CRO seeks a Senior Medical Writer in Toronto, Ontario, or remote in Canada. Responsibilities include authoring regulatory documents, developing drafts, and managing projects. The ideal candidate has a Ph.D. and 5+ years of relevant medical writing experience, with strong skills in clinical trials and document preparation. Salary range is...
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Senior Medical Writer
4 weeks ago
Markham, Toronto, Montreal, Calgary, Vancouver, Edmonton, Old Toronto, Ottawa, Mississauga, Quebec, Winnipeg, Halifax, Saskatoon, Burnaby, Hamilton, Victoria, Surrey, Halton Hills, London, Regina, Brampton, Vaughan, Kelowna, Laval, Southwestern Ontario, R, Canada Everest Clinical Research Full timeA leading clinical research organization is seeking a Senior Medical Writer to join their team in Markham, Ontario, or remotely anywhere in Canada. The role involves writing clinical documents, managing projects, and ensuring quality in all deliverables. Ideal candidates will hold a Ph.D. or Master’s degree and have a minimum of five years of experience in...
