Senior Manager, Compliance

Job Description

Job Description

About the Job

Assist Chief Compliance Officer, North America (CCO), with the design, implementation, oversight, and enforcement of policies and practices to ensure corporate compliance with regulatory requirements relevant to pharmaceutical manufacturers in the United States and Canada. The Senior Manager, Compliance reports directly to the CCO.

Job Responsibilities

Note : These statements are not intended to be an exhaustive list of all responsibilities and duties.

• Maintain all compliance files in an organized manner.
• Serve as custodian of compliance files.
• Provide administrative and other day-to-day support to CCO.
• With input from CCO, maintain master tracker of ongoing work-flows, Corrective and Preventive Actions (CAPAs) and follow-up with appropriate individuals as needed.
• Assist in drafting / reviewing / revising relevant compliance / business policies and standard operating procedures (SOPs)
• Assist CCO in organizing, developing agenda and designing presentations for Compliance Committee Meetings.
• Serve as Secretary at Compliance Committee Meetings.
• Assist with auditing, monitoring and enforcement of Compliance efforts, including assisting with risk assessments, review of emails and other documents, etc.
• Research, adopt and leverage innovative technology to identify and mitigate compliance risks
• Develop, assign, coordinate and track status of compliance-related training.
• Follow-up with individuals who failed to attend trainings in a timely manner.
• Coordinate and ensure exclusion and debarment checks are performed on a regular basis.
• Track Compliance Department monthly spend.
• Reconcile monthly spend with budget.
• Assist CCO with compliance investigations and CAPAs. This may include maintaining notes, requesting and reviewing files, drafting reports, and participating in interviews.
• Maintain understanding of laws and regulations, enforcement actions and evolving practices relevant to pharmaceutical compliance and works with CCO to make updates to Compliance program as appropriate.
• Gather information and conduct research relative to compliance issues.
• Research and analyze statutes, regulations and other legal resources.
• Work with cross-functional stakeholders to collect, analyze and submit required information and data for transparency reporting.
• Ensure that training and updates are provided to members of relevant functions.

Qualifications

Education

Experience

Knowledge and Skills

Physical Demands and Abilities

Compensation and Benefits

Salary Range - $135,000 – 160,000

The compensation range provided reflects the expected base compensation only and does not include potential bonuses, incentive plans, or benefits. An individual’s final compensation offer will be based on a variety of factors, including but not limited to education level, relevant experience, training, and geographic location.

Benefits include :

About the Company

Glenmark is a global leader in the development and commercialization of generic drugs of the highest quality and value. We help to improve people’s lives every day by helping to reduce their healthcare costs while delivering high-quality medicines.

Established in 2003 as a North American subsidiary of Glenmark Pharmaceuticals, we launched our first generic product in January 2005 and quickly emerged as one of the leading generic organizations in the United States.

Today we have a diverse business. As a global leader in generics, we are leveraging our industry expertise and success to fuel extensive research to expand development in specialty branded products innovative products that are intended to have a major impact on how people live.

This job description is to serve as a guide. It is intended to be flexible and will continue to evolve over time with business needs and demands and may be updated periodically and at the Company’s discretion. Nothing in this position description changes or is intended to change the employment at-will relationship with the Company. Employment at-will means that an employee or the Company may terminate the employment relationship at any time, for any reason or no reason at all, with or without notice.

Glenmark Pharmaceuticals is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.