Job Description
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Pharma Medica Research is a full service
Contract Research Organization
specialized in conducting early phase clinical trials in healthy volunteers, special and patient populations. We are always looking for top talent to join our amazing team! Currently we are looking for a
Director, Medical Writing
to join our Head Office in Mississauga, Ontario!
The Director, Medical Writing is responsible for overseeing all medical writing projects for clients and project teams, managing internal staff, maintaining optimal medical writing and departmental processes, implementing project-specific strategies and leading the development of departmental strategies to increase and maintain effective productivity and quality. This position reports to the Vice President, Scientific Affairs and/or designate.
Duties and Responsibilities:
Manage and provide general assistance to the protocol and report writing teams.
Organize and maintain the writing work schedule; assign suitably experienced writers to projects to ensure the maintenance of document quality and project timelines.
Provide ongoing training to the protocol and report writing teams.
Advise on medical writing issues as detailed in the current ICH, FDA, TPD and EMA guidelines.
Liaise with Project Management, sponsors, and management regarding the availability of resources and the establishment of project timelines.
Liaise with Project Management, Data Management, Pharmacokinetics, Biostatistics, Bioanalytical Laboratory and QA teams to ensure the maintenance of document quality and project timelines. Monitor overall ongoing project performance and, if necessary, identify ways to ensure that deliverables are completed on‑time and within budget. Keep project management team informed of study status.
Assist in the preparation and/or review of documents, including, but not limited to, Clinical Study Reports, Study Protocols, Informed Consent Forms, SOPs, Mock Tables, Statistical Analysis Plans, and all other documents related to Medical Writing.
Review drafts and final versions of study protocols and clinical study reports to ensure quality and compliance with sponsor and regulatory requirements, as well as ensure all sponsor comments are addressed.
Work with management to identify opportunities for process improvements and cost savings.
Analyze current work methods and processes and identify opportunities to implement common processes and best demonstrated practices.
Measure and analyze current state and the results of changes made, with the objective of sustaining and continually building upon improvement.
Act as a mentor and leader for colleagues regarding all aspects of protocol and clinical study report development and related topics, including providing training to direct reports as required.
Assist in the writing of study abstracts, posters, and manuscripts.
Participate in sponsor teleconferences, as required.
Train new staff, as required.
Other duties as required.
Qualifications:
University degree in a scientific discipline preferred.
5+ years 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.
High degree of self‑motivation and ability to work efficiently and independently under pressure. Ability to work independently as a team player and team leader, understanding of team dynamics.
Strong knowledge of processes with a desire to promote improvement. Ability to motivate and energize others with a positive, can‑do attitude.
Strong verbal, written and facilitation skills.
Must possess good computer skills and organizational skills. Experience with an electronic document control and management system would be a plus.
Excellent interpersonal skills
We offer:
Competitive compensation plan
A benefit plan that is fully paid for by PMRI, including healthcare, dental care, 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
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.
If you're interested in this opportunity, apply today! Great working environment with competitive compensation and benefits package offered!
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