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Glenmark Pharmaceuticals · 2 weeks ago

Senior Manager, Compliance

Elmwood Park, NJ

Full-time

Onsite

Senior Level

$135K/yr - $160K/yr

Glenmark Pharmaceuticals is a global leader in the development and commercialization of generic drugs. The Senior Manager, Compliance will assist the Chief Compliance Officer in ensuring corporate compliance with regulatory requirements relevant to pharmaceutical manufacturers, and will be responsible for maintaining compliance files, supporting compliance training, and assisting with compliance investigations.

BiotechnologyHealth CarePharmaceutical

Responsibilities

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

Qualification

Pharmaceutical compliance experienceCompliance program developmentMS Office masteryCompliance certificationCorporate training experienceAttention to detailInterpersonal skillsWork ethicWork independently

Required

Bachelor's degree required, preferably in legal or accounting

Prior pharmaceutical compliance experience required

Mastery of MS Office, including Word, Excel, and Outlook

Strong moral compass and exhibits high standard of personal integrity

Must be organized and have a strong attention to detail

Must be able to work well under pressure, meet short deadlines, and shift priorities seamlessly

Must be able to work independently

Must have a strong work ethic

Must have excellent interpersonal skills and be able to collaborate and communicate with individuals at all levels within the organization

Preferred

Education/certification related to compliance is preferred

Experience providing corporate training is preferred

Experience in building and implementing key components of an effective compliance program, including written standards, training, auditing and monitoring and investigations, is preferred