Senior Manager, Compliance

Glenmark Pharmaceuticals•Elmwood Park, NJ

1d•Onsite

About The Position

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.

Requirements

Bachelors 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.

Nice To Haves

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.

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.