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 a full service contract research organization specialized in conducting early phase clinical trials in healthy volunteers, special and patient populations. We are actively looking for exceptional and passionate individuals who want to work in a learning, innovative team. We are currently looking for an Associate Medical Writer to join our Mississauga team!
Duties and responsibilities:
- 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, MOCK TLF to ensure consistency with the study protocol, SAP, 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.
- Assist in the development of tools and techniques to improve the quality and efficiency of the Report Writing team.
- Participate in sponsor teleconferences, as required.
- The tasks below (10 to 13) are related to generation of the study protocol and ICF, such tasks may be assigned to MW in the report team by management when necessary and provided the individual has received the appropriate training.
- 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.
- Perform literature review on selected topics.
- Responsible for acquiring and maintaining knowledge of national and international regulatory guidelines.
- Responsible for writing technically and grammatically accurate materials that consistently meet the quality standards of PMRI.
- Other duties as required.
Qualifications:
- BSc in Medical Sciences or Health Science field.
- A year of Medical Writing experience in a Contract Research Organization (CRO), pharmaceutical, medical 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.
- Ability to multitask and work on multiple projects simultaneously.
- Excellent interpersonal and oral communication skills.
We offer:
- Competitive compensation plan
- Mentorship Opportunities
- 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.
We thank all applicants for their interest; however, only those selected to proceed in the interview process will be contacted.
