Medical Writer

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.