Senior Scientific Medical Writer-I
3 weeks ago
Senior Scientific Medical Writer-I - BioPharma Services Inc Responsibilities Write Phase 1-IV and Bioequivalence Study Protocols and Informed Consent Forms. Perform Literature search, NDA review and scientific discussion relevant to designing a study protocol for BE and Phase 1-2a (Proof of concept). Review non-clinical data in preparation for the transition to the First in Human clinical trial. Interact efficiently with PK Scientists and Biostatisticians to ensure that the study design is in line with the most up‑to‑date regulatory and scientific requirements. Interact with Institutional Review Boards regarding Protocols, Informed Consent Forms and other documents as required. Assist in the development of Standard Operating Procedures (SOPs) and guidelines linked with the department’s activities. Assist with the preparation for Regulatory agencies and participate, if needed, in any discussion with inspectors. Work closely with scientific, clinical personnel, and the Principal Investigator to ensure that clinical study protocol and other scientific documents are produced to the standard required by Good Clinical Practice (GCP), SOP and other applicable guidelines. Establish optimal timelines with external departments to meet study timelines. Perform other work within the Scientific Affairs department as needed. Qualifications Minimum University degree: PhD. (i.e., Pharmacy, Pharmacology or other Life Sciences relevant degree). At least 3 years of Scientific Protocol design and Writing experience. Experience in a CRO environment is an asset, preferably in the conduct of Phase I and Bioequivalence studies. Excellent scientific writing skills. Excellent interpersonal and communication skills. Attentive to details, good initiative and able to work with changing priorities under tight timelines. Previous participation in Scientific discussions with Agencies (e.g., Scientific Advice meeting in EU, Pre‑IND packaging and meeting with the FDA) is an asset. Seniority level Mid-Senior level Employment type Full‑time Job function Marketing, Public Relations, and Writing/Editing Industries Hospitals and Health Care #J-18808-Ljbffr
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Senior Scientific Medical Writer-I
3 weeks ago
Toronto, Canada HEALWELL AI (TSX: AIDX) Full timeSenior Scientific Medical Writer-I - BioPharma Services Inc Responsibilities Write Phase 1-IV and Bioequivalence Study Protocols and Informed Consent Forms. Perform Literature search, NDA review and scientific discussion relevant to designing a study protocol for BE and Phase 1-2a (Proof of concept). Review non-clinical data in preparation for the transition...
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Senior Scientific Medical Writer-I
3 weeks ago
Toronto, Canada HEALWELL AI (TSX: AIDX) Full timeSenior Scientific Medical Writer-I - BioPharma Services Inc Responsibilities Write Phase 1-IV and Bioequivalence Study Protocols and Informed Consent Forms. Perform Literature search, NDA review and scientific discussion relevant to designing a study protocol for BE and Phase 1-2a (Proof of concept). Review non-clinical data in preparation for the transition...
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Senior Medical Writer — Scientific Storytelling
2 weeks ago
Toronto, Canada Ogilvy Full timeA creative agency in Toronto is seeking a Senior Medical Writer to develop and manage a variety of scientific content. The role involves conducting research, writing medical documents, and collaborating with teams to maintain project timelines and quality. Candidates should have a relevant science degree and over 4 years of medical writing experience. Strong...
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SENIOR MEDICAL WRITER
3 weeks ago
Toronto, Canada Ogilvy Canada Full timeJoin to apply for the SENIOR MEDICAL WRITER role at Ogilvy Canada About Ogilvy Ogilvy has been creating impact for brands through iconic, culture-changing, value-driving ideas since the company was founded by David Ogilvy 75 years ago. It builds on that rich legacy through Borderless Creativity – innovating at the intersections of its advertising, public...
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SENIOR MEDICAL WRITER
3 weeks ago
Toronto, Canada Ogilvy Canada Full timeJoin to apply for the SENIOR MEDICAL WRITER role at Ogilvy CanadaAbout OgilvyOgilvy has been creating impact for brands through iconic, culture-changing, value-driving ideas since the company was founded by David Ogilvy 75 years ago. It builds on that rich legacy through Borderless Creativity – innovating at the intersections of its advertising, public...
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SENIOR MEDICAL WRITER
3 weeks ago
Toronto, Canada Ogilvy Canada Full timeJoin to apply for the SENIOR MEDICAL WRITER role at Ogilvy CanadaAbout OgilvyOgilvy has been creating impact for brands through iconic, culture-changing, value-driving ideas since the company was founded by David Ogilvy 75 years ago. It builds on that rich legacy through Borderless Creativity – innovating at the intersections of its advertising, public...
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SENIOR MEDICAL WRITER
3 weeks ago
Toronto, Canada Ogilvy Full timeJoin to apply for the SENIOR MEDICAL WRITER role at Ogilvy About Ogilvy Ogilvy has been creating impact for brands through iconic, culture-changing, value-driving ideas since the company was founded by David Ogilvy 75 years ago. It builds on that rich legacy through Borderless Creativity – innovating at the intersections of its advertising, public...
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SENIOR MEDICAL WRITER
3 weeks ago
Toronto, Canada Ogilvy Full timeJoin to apply for the SENIOR MEDICAL WRITER role at Ogilvy About Ogilvy Ogilvy has been creating impact for brands through iconic, culture-changing, value-driving ideas since the company was founded by David Ogilvy 75 years ago. It builds on that rich legacy through Borderless Creativity – innovating at the intersections of its advertising, public...
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SENIOR MEDICAL WRITER
3 weeks ago
Toronto, Canada Ogilvy Full timeJoin to apply for the SENIOR MEDICAL WRITER role at Ogilvy About Ogilvy Ogilvy has been creating impact for brands through iconic, culture-changing, value-driving ideas since the company was founded by David Ogilvy 75 years ago. It builds on that rich legacy through Borderless Creativity – innovating at the intersections of its advertising, public...
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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...
