Manager Clinical Affairs

4 days ago

Richmond Hill Ontario, York region, Canada Prollenium Medical Technologies Inc. Full time

COMPANY OVERVIEW:

Prollenium Medical Technologies Inc. is a fast-growing Canadian developer, manufacturer, and international distributor of premium HA dermal filler. We are proud to address all of our client's needs through streamlined medical device innovation. Prollenium is able to ensure a continual flow of creation, unique ideas, and a steady pipeline of new and exciting products that provide safe and effective results. US FDA, Health Canada, and CE approvals, over 4 million syringes in the Revanesse product line have been sold to 70+ countries world-wide. Prollenium is the only manufacturer of Hyaluronic Acid dermal fillers in North America. Join our dedication to innovation.

Prollenium provides competitive compensation, benefits, and development opportunities.


JOB SUMMARY:

The Clinical and Medical Affairs Manager will support the clinical research programs and medical affairs activities in North America. This role assists in developing and monitoring clinical trials, ensures adherence to applicable regulations, maintains clinical documentation, and supports business development efforts. This position reports to the Chief Regulatory, Clinical and Medical Affairs Officer.


MAJOR RESPONSIBILITIES:

  • Ensure full compliance to all appropriate regulations: SOPs, GCPs, FDA and Health Canada regulations.
  • Assist in the planning, management and execution of clinical trials.
  • Help identify and evaluate investigational sites in North America.
  • In collaboration with external vendors, assist in building, organizing and maintaining the Trial Master File throughout the study.
  • Collaborate with vendors for Medical Writing, Medical Monitoring, Data Management, and Statistics, as required.
  • Help with planning and management of study budgets.
  • Secure IRB study approvals and help with sites' IRB submissions and approvals.
  • Support business development efforts by building and maintaining relationships with industry professionals, clinicians, and investigators.
  • Collaborate and support North American medical affairs activities, such as training sessions, advisory boards, CME events, presentations, etc.


MINIMUM QUALIFICATIONS:

Technical Knowledge/Experience:

  • University degree or Masters (scientific).
  • Minimum 3-5 years of experience in clinical and medical affairs management in the pharmaceutical or medical device industry.
  • Excellent written and oral communication skills.

Behavioral:

Demonstrated ability to apply the following behavioral competencies on the job:

  • Teamwork: Working effectively and productively with others.
  • Customers Focused
  • Decision Making: Utilizing effective processes to make decisions.
  • Goal Orientation: Energetically focusing efforts on meeting a goal, mission, or objective.
  • Problem Solving: Anticipating, analyzing, diagnosing, and resolving problems.


PREFERRED QUALIFICATIONS:

  • Track record of completed clinical trials, from conception to publication (drugs and/or medical devices)
  • Experience in medical affairs activities, such as advisory boards, IITs (Investigator- Initiated Trials), educational programs development, etc.


WORKING CONDITIONS:

  • Occasional travel may be required.

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