Medical Writer

3 weeks ago

Mississauga ON, Canada Pharma Medica Research Inc. Full time

Pharma Medica Research (PMRI) is a Contract Research Organization that strives for innovation and original solutions in a highly regulated and competitive industry. We are actively looking for exceptional and passionate individuals who want to work with an exceptional team in healthcare. If you strive for learning, innovation and original thinking you will be the perfect candidate to be part of an inclusive, adaptable, and forward-thinking organization.Currently we are looking for a Medical Writer to join our Mississauga teamThe Medical Writer will serve an integrative position designed to contribute to allmedical writing activities at Pharma Medica Research Inc.( PMRI), dynamically unitingscientific medical knowledge and written communication skills. More specifically, theMedical Writer will contribute to key aspects involved in the writing of protocols andClinical Study Reports (CSRs). This position reports to the Director, Medical Writingand/or designate.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.Qualifications:M.Sc., Ph.D., or Pharm.D. in any Medical Sciences field.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.Ability to work as a team player and with the team dynamics.Excellent interpersonal and oral communication skills.Why is PMRI the place for you? We offer: A comprehensive benefits plan, including healthcare, dentalcare, vision care, LTD, Life Insurance, AD&D, along with a Health Spending and Wellness Spending Accounts and a voluntary RRSP Contribution PlanOpportunities for advancement and career progressionGenerous Employee Milestones Awards ProgramDiscounts ProgramFriendly atmosphere, culture of learningPlease 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.We thank all applicants for their interest; however, only those selected to proceed in the interview process will be contacted.

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