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Bilingual Medical Information Manager - Montreal Area

Reference: 018141
This vacancy has now expired.

Mapi is adding a Bilingual Medical Information Manager Contractor for a one- year contract to our North American team!     Qualified candidates must be fully bilingual French-English, as the patient and professional audience for this role will be fluent in either/both languages, preferably located in the Montreal area.

The Medical Information Manager  is responsible for all medical information duties to support clients in compliance with applicable regulation, the company's Standard Operating Procedures (SOPs), and project-specific operational agreements. The role also participates in business development activities. 

The primary responsibilities include:

  • Prioritizing and complete multiple projects within established time frames.
  • Managing client projects, including managing client relationships and project budgets.
  • Monitoring and managing project-specific email accounts, incoming faxes and telephone calls. Preliminary triaging of incoming information to determine classification, priorities and time frames for subsequent activities.
  • Entering information for medical information inquiries into medical information databases, tracking systems and project-specific forms ensuring accurate data-entry.
  • Maintaining a library of responses to Frequently Asked Questions and of Standard Response Letters.
  • Responding to medical information inquiries within predetermined timelines and constraints, requesting assistance from clients and safety physicians as appropriate.Identifying Individual Case Safety Reports and technical product complaints and forwarding them to the relevant stakeholders within pre-determined timelines.
  • Assisting with or performing reconciliation of safety databases, safety tracking systems, medical information databases, product complaint databases and clinical databases.
  • Monitoring and interpreting worldwide regulations pertaining to medical information and pharmacovigilance, providing regulatory expertise to colleagues and clients.
  • Assisting with regulatory agency inspections, client audits and internal audits.
  • Participating as an active member of multidisciplinary teams to successfully achieve project and corporate goals. Identifying project issues and developing proposals for alternative strategies for discussion with superiors.
  • Mentoring less-experienced team members.
  • Other duties as determined.
-       Education:  Completion of a life sciences degree (e.g. BSc, RN, MSc, PharmD). Advanced degree an asset (e.g. MSc, PhD).
-       Area Equivalent: At least 2 years' experience in a scientific discipline or health-related field required.
-       Experience: At least 5 years' experience within medical information and/or pharmacovigilance required; at least 10 years' experience required for Senior Medical Information Manager.
-       Exceptional communications experience including written, verbal, and presentation skills.
-       Minimum 4 (four) years' advanced work experience with all Microsoft Office Suite Products (Excel, Word, PowerPoint, Outlook) as well as other software and databases.
-       Comprehensive experience in pharmacovigilance including knowledge of ICH, EEA, Good Pharmacovigilance Practices (GVP), US and Canadian legislation and regulatory guidance.
-       Sound written and oral communication skills, good organizational and planning skills, and effective presentation skills to a variety of audiences.
-       Ability to build positive, productive relationships with colleagues and clients.
-       Medical Information Manager II may be required to mentor or manage less experienced staff.
-       Medical Information Manager II may be required to develop new departmental procedures or systems, and/or monitor the progress of ongoing departmental procedures.
-       Medical Information Manager II may be required to be involved in business development activities, including development of quotes and proposals.

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