Associate Director, Medical Affairs Compliance

Employer
Merck
Location
Montreal (Kirkland), QC, CA
Posted
February 02 2018
Discipline
Other
Organization Type
Pharma
Requisition ID: COM000588

The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its 125-year legacy. With a diversified portfolio of prescription medicines, vaccines and animal health products, Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. 


Reporting to the Vice-President of Medical Affairs, the Associate Director, Medical Affairs Compliance is primarily responsible for maintaining patient safety and operating with the highest standard of ethics and integrity in Medical Affairs activities. 

 The Associate Director is accountable for:
  • Preparing and conducting training and audits of Merck Canada SOPs and procedures on a regular basis for all Medical Affairs personnel
  • Providing compliance guidance and support on Medical Affairs activities
  • Identifying needs and developing relevant SOPs/Job Aids to ensure that all Medical Affairs activities adhere to compliance requirements
  • Collaborating with cross-functional teams for full alignment on the compliance processes and standards within Merck Canada
 The Associate Director will interact with all Medical Affairs associates, delegates from Legal and Compliance, as well as Commercial functions.

  Core responsibilities include:

 Compliance/quality control checks/monitoring activities/audits
  • Supporting the VP , Medical Affairs in creating the annual monitoring plan for Medical Affairs activities (ex:  HCP interactions, Phase IV studies, advisory boards)
  • Executing on annual monitoring plan
  • Ensuring action items are followed up on by responsible individuals
                                          Merck Canada SOPs and Procedures maintenance
  • Maintaining a high level knowledge of the Corporate policies and procedures
  • Identifying the need for creation/revision of existing Merck Canada SOPs
  • Managing the SOPs, ensuring communication of the SOPs to employees, developing and delivering training to relevant employees
                                                      FCPA Due Diligence for Third Parties (Hiperos) initiative:
  • Supporting Procurement in ensuring a due diligence is conducted on identified vendors.
  • Supporting the activity owners (within Business Units) in navigating through the Hiperos system
 
  • Taking an active role in the HCP Payment Disclosure Initiative and ensuring activity is conducted in a compliant manner
  •  Supporting the VP, Medical Affairs in setting a high standard of compliance and implementing cross-functional collaboration to build excellence within business practices
  • Representing Medical Affairs at the compliance committee of Merck Canada and collaborating with cross-functional teams on key compliance-related initiatives.   Acting as country compliance lead of Medical Affairs for regional and global initiatives.
 Qualifications

  • Education: Minimum of Bachelor degree
  • Minimum 10 years of pharmaceutical experience with multiple pharma companies
  • Strong knowledge and understanding of business operations including Sales, Marketing and Medical Practices
  • Strong experience in Business Compliance and strong knowledge of Health Canada Regulations and IMC Code of Ethical Practices
  • Strong knowledge of Merck/Corporate Compliance Policies, SOPs and procedures would be an asset
  • Demonstrated solid compliance mindset and detail oriented
  • Ability to explain the importance of compliance and gain employee agreement to comply with processes.
  • Excellent communication skills both verbal and written in French and English
  • Strong presentation skills
  • Strong analytical and problem solving skills and ability to manage ambiguity
  • Excellent interpersonal skills and a collaborative management style
  • Ability to lead a cross-functional team
  • Ability to leverage and engage cross-functional resources in support of specific needs.
  • Bilingualism (French and English) is a requirement.
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.

 Our employees are the key to our company's success.  We demonstrate our commitment to our employees by offering a competitive and valuable rewards program.  Merck's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. Merck is an equal opportunity employer, proudly embracing diversity in all of its manifestations. 

 Search Firm RepresentativesPlease Read Carefully: Merck is not accepting unsolicited assistance from search firms for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at Merck via-email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck.  No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means. 




Job: Compliance Officer
Other Locations:
Employee Status: Regular
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Company Trade Name: Merck

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