Associate Medical Writer - Mississauga, Ontario
1 day ago
Job description
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 researching of national and international regulatory guidelines.
- Generate high quality study-related materials and documents as required for Phase I-III studies including, but not limited to: protocols, informed consent forms (ICFs), checklists, manuscripts, Investigator's Brochures, protocol summary documents, CSRs, regulatory summaries and other CSR-related documents.
- Prepare materials and documents compliant with
PMRI
standards, Sponsor requirements, and regulatory guidelines. - Collaborate with the required departments regarding relevant sections of the protocol and CSR.
- Assist in reviewing study-related materials and documents for accuracy and quality.
- Assist in literature review on selected topics to provide scientific material needed for, but not limited to, background and introduction, study rationale, drug safety, and results discussion.
- Assist in summarizing available and related literature needed for study documents. Submit protocol-related documentation and CSR to the Project Management department for sponsors and the regulatory authorities (including Institutional Review Boards [IRB]).
- Ensure projects are delivered in a timely manner.
- Review clinical documentation and output generated by CDM to aid in QC of the study documents and results tables.
- Use study templates (e.g. protocol, ICF, CSR), check lists, and Training Manual to write the required documents.
- Respond to sponsor comments related to protocols and CSRs.
- Review electronic case report form (eCRF) design and Mock tables to ensure consistency with the study protocol and requirements from a clinical/medical perspective, as well as consistency with PMRI standards, Sponsor requirements, and regulatory guidelines.
- Participate in sponsor teleconferences, as required.
- Responsible for writing technically and grammatically accurate materials that consistently meet the quality standards of
PMRI
. - Other duties as needed.
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.
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