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.
