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Toronto, Canada Syneos Health, Inc. Full timeA leading biopharmaceutical organization in Toronto seeks a Principal Medical Writer. This role demands expertise in medical writing, focusing on clinical studies and regulatory submissions. Candidates must have 3–5 years of relevant experience, understand FDA and ICH regulations, and excel in English communication. Responsibilities include leading...
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Toronto, Canada Syneos Health, Inc. Full timeA global biopharmaceutical solutions organization seeks a Principal Medical Writer in Toronto to oversee the accurate completion of complex medical writing deliverables. You will engage with cross-functional teams and ensure compliance with regulatory standards. Responsibilities include leading document preparations for clinical studies and guiding junior...
Medical Writer
1 month ago
Pharma Medica Research (PMRI) Inc. is a Contract Research Organization that strives for innovation and original solutions in a highly regulated and competitive industry. If your career goals align with innovation and original thinking you will be the perfect candidate to be part of an inclusive, adaptable, and forward-thinking organization. Our reputation for delivering high quality research is outstanding. At PMRI we are committed to making a difference in healthcare and people’s lives. Come join our team We are currently looking for a Medical Writer to join our team. Duties and Responsibilities: Generate protocols, informed consent forms, checklists, protocol summary documents or any other documents related to study conduct, as required for Phase I-III studies. Collaborate with the required departments regarding relevant sections of the protocol. Ensure the protocol is reviewed for accuracy and quality by designated review staff in various departments. Submit protocol-related documentation to the Project Management department/IRB for sponsors and the regulatory authorities. Responsible for writing safety and efficacy conclusions in the CSR, based on the interpretation of study data, as required for Phase I to III studies. May be required to write additional sections of the CSR, if required, and to contribute to relevant sections of CSBE and SwissMedic documents. If applicable, review clinical documentation to aid in the writing of safety and efficacy conclusions. Use report format templates, check lists, and Training Manual relating to the CSR. Prepare correspondence to sponsors regarding the CSR and respond to sponsor comments. Review of eCRF design to ensure consistency with the study protocol and requirements from a clinical/medical perspective. Review output generated by the Clinical Data Management team with regards to consistency and relevance from a clinical/medical perspective. Act as a mentor and resource for colleagues regarding all aspects of the Protocol and Report Writing departments. Assist in the development of tools and techniques to improve the quality and efficiency of the Protocol Writing and Report Writing departments. Participate in sponsor teleconferences, as required. Perform literature review on selected topics. Responsible for acquiring and maintaining knowledge of national and international regulatory guidelines. Other duties as required. Requirements B.Sc. in any Medical Sciences or Health Science related field. 2 years of Medical Writing experience in a CRO, pharmaceutical, and/or biotechnology environment. Thorough knowledge of International Conference on Harmonization (ICH), Good Clinical Practice (GCP) guidelines, and other applicable regulatory rules and guidelines. Strong knowledge of medical terminology, clinical trials, and clinical research. Solid writing and editorial skills. Familiarity with medical terminology and therapeutic drug areas. High degree of self-motivation and ability to work efficiently and independently under pressure. Solid computer skills including Microsoft Office Ability to work as a team player and with the team dynamics. Excellent interpersonal and oral communication skills. We offer: Competitive compensation plan A benefit plan that is fully paid for by PMRI, including healthcare, dentalcare, vision care, LTD, Life Insurance, AD&D, along with a Health Spending and Wellness Spending Accounts and a voluntary RRSP Contribution Plan Opportunities for advancement and career progression A generous Employee Milestones Awards Program Corporate Discounts Program Friendly atmosphere, culture of learning Please note all applications must be eligible to work within Canada. PMRI is an Equal Opportunity Employer; promoting accessibility and inclusivity at work and offering accommodation for applicants as required and requested.
