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 seeking a Sr. Medical Writer/Clinical Research Scientist to join our team!
Responsibilities:
- Author and oversee the development of key clinical documents, including protocols, informed consent forms (ICFs), investigator brochures (IBs), and clinical study reports (CSRs) for a variety of studies for Phase 1 to 3 clinical trials, ensuring compliance with regulatory standards and study objectives.
- Develop, update, and review the templates for protocols, ICFs, IBs, and clinical reports to ensure consistency, quality, and compliance with regulatory requirements.
- Collaborate with the required departments regarding relevant sections of the protocol. Work closely with Pharmacokinetic/Stat/Data management team to evaluate the study data and results, providing insights to support decision-making and study integrity.
- Ensure the protocol is reviewed for accuracy and quality by designated review staff in various departments.
- Review and align statistical analysis plans (SAPs) with study objectives (including preparation of mock tables), ensuring methodological accuracy, and monitor the precision of Tables, Figures, and Listings (TFLs) for clear and effective data presentation.
- Responsible for writing all aspects of the CSR, including elaborate discussions of safety and efficacy conclusions based on the interpretation of study data, as required for Phase I to III studies.
- Prepare additional electronic files as required by Regulatory Agencies (e.g., eCTD, CSBE, FDA BE Summary Tables, EMA Module 2.7.1 Tables, SwissMedic).
- 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.
- Develop, write, and implement and maintain the Standard Operating Procedures (SOPs) related to Medical Writing.
- Participate in sponsor teleconferences, as required, such as: Participate in Safety Review Committee (SRC) meetings, providing expert input on data interpretation and contributing to dose selection strategies to ensure participant safety and study integrity.
- Perform literature review on selected topics. Provide scientific support to various departments throughout the lifecycle of clinical studies, ensuring optimal timelines and compliance with project requirements.
- Responsible for acquiring and maintaining knowledge of national and international regulatory guidelines.
- When required, assist in the training of new staff.
- Other duties as required.
Requirements:
- M.Sc., Ph.D., or Pharm.D. in any Medical Sciences field.
- At least 5 years of Medical Writing experience in a CRO, pharmaceutical, and/or biotechnology environment.
- Experience with medical writing for clinical trial protocol for early and later phase and CSR for regulatory submission
- 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 numerous therapeutic drug areas.
- High degree of self-motivation and ability to work efficiently and independently under pressure.
- Ability to work as a scientific leader with team dynamics.
- 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 Spendingand Wellness Spending Accounts and a voluntary RRSP Contribution Plan
- Opportunities for advancement and career progression
- A generous Employee Milestones Awards Program
- Corporate Discounts Program
- Learning Support Programs
- 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.
