Protocol Writer - Clinical Trials

Pharma Medica Research (PMRI) is a Contract Research Organization that strive for innovation and original solutions in highly regulated and competitive industry. If you strive for innovation and original thinking you will be the perfect candidate to be part of an inclusive, adaptable, and forward-thinking organization. We're currently looking for a Protocol Writer to join our Mississauga team!

Position Summary:

The Protocol Writer will be responsible for all actions relating to protocol development and maintenance. This position will guide and provide mentorship to the Protocol Writing (PW) team in the writing of protocols for Phase I-III studies. This position reports to the Manager, Protocol Writing and/or designate.

Duties and Responsibilities:

• Liaise with Project Management and other internal departments to ensure the maintenance of protocol-related document quality and project timelines, including the submission of protocols to sponsors and regulatory authorities.
• Draft/propose documents (i.e. questionnaires) related to selected topics in protocols.
• Collaborate with PK Scientists and Biostatisticians with generation of Statistical Analysis Plans and mock tables and listings documents.
• Review drafts and final versions of study protocols to ensure quality and compliance with sponsor and regulatory requirements, as well as ensure all sponsor comments are addressed.
• Train new staff, as required.
• Ensure timely and accurate entries and updates into a computer management system required for clinical conduct.
• Assist in the development of innovative tools and techniques to improve the quality and efficiency of the PW department, including medical writing techniques.
• Generate protocols, informed consent forms, revisions and synopses or any other documents related to study conduct, as required.
• Participate in sponsor teleconferences, as required.
• Act as a mentor for colleagues regarding all aspects of protocol development.
• Address sponsor queries and comments to protocols.
• Responsible for acquiring and maintaining knowledge of national and international guidelines related to protocol development, in co-operation with the Director, Scientific Affairs, or designate.
• Other duties as required.

Qualifications:

• 3 or more years of pharmaceutical related experience in medical writing, preferably in a CRO.
• Ability to think innovatively and write protocols utilizing high level clinical trial designs, often times with multiple study objectives
• Completed a university degree (B.Sc., M.Sc.)
• 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.
• Must possess good computer skills and organizational skills. Experience with an electronic document control and management system would be a plus.
• Strong knowledge of processes with a desire to promote improvement. Ability to motivate and energize others with a positive, can-do attitude.
• Excellent interpersonal skills
• Critical eye for detail and review.
• 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.

We offer:

• Learning Support Programs
• Competitive compensation plan
• A generous Employee Milestones Awards Program
• 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
• Friendly atmosphere, culture of learning
• Corporate Discounts Program
• Mentorship Opportunities
• Opportunities for advancement and career progression

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.