Global pharmaceutical company located in North NJ seeks a Senior Manager, Compliance Operations to join their team. Base salary is up to $140K plus a 16%-20% target bonus.  

Primary Duties

The Senior Manager, Compliance Operations will be responsible for creating, updating, implementing, and maintaining the Company's compliance policies and procedures. The candidate will also be responsible for implementing, educating other groups, and serving as the Compliance department’s document steward for the Company's new doc management system, eDocs. The candidate will also support training needs of the department based on changes/updates to any laws, regulations, policies or procedures. Additional responsibilities include the following: 

• Oversees the Compliance department's strategic initiative to upgrade and rewrite policies and procedures into a new format and add additional policies needed to ensure compliance with applicable laws and regulatory requirements.
• Be the subject matter expert on policy and procedure standards and use of the Company's eDocs System for Compliance.
• Ensure policy and procedure owners utilize the required templates by working directly with and providing training to the owners on how policies and procedures are to be structured and written in compliance with the new eDocs system.
• Work with other stakeholders to develop new or revisions to existing policies and procedures as new regulatory requirements are published and update training pieces as needed.
• Work closely with other Compliance department personnel to ensure all applicable regulatory requirements are included in appropriate policies and procedures.
• Ensure all policies are aligned with the appropriate approving body and properly scheduled for ongoing submission to and review and approval by the appropriate business owner.
• Responsible for accurate content in and appropriate usage eDocs including maintaining archived historical versions of draft and published policies and procedures in compliance with The Company's record retention requirements.
• Evaluate the effectiveness of existing policies and procedures, initiate enhancements as identified, and create/update training materials based on updates/enhancements.
• Monitors training programs and manuals to ensure that they are effective and up-to-date and makes updates as necessary.
• Work with Monitoring function and other subject matter experts to develop content for training materials based on the Company's policies and procedures.
• Support departmental and cross-functional compliance projects as needed such as RAMP, survey administration and training follow up.

Requirements

• 5+ years of related healthcare compliance policy-procedure management
• 3+ years of pharmaceutical/biotech industry experience with Compliance or Legal, or equivalent experience preferred
• Bachelor’s degree required
• Prior strong project management experience managing projects crossing numerous functions and stakeholders
• Strong knowledge of key laws and regulations impacting the pharmaceutical industry including the PhRMA Code; Federal Food, Drug, Cosmetic Act; Anti-Kickback Statue; False Claims Act, OIG/DOJ Guidance; Foreign Corrupt Practices Act; and federal and state transparency and disclosure laws.
• Excellent written and verbal communication skills
• Strong attention to detail including ability to accurately edit written documentation
• Strong interpersonal and collaboration skills in order to interface effectively with various cross-functional groups
• Strong project management skills such as scheduling, planning, and prioritizing several diverse activities, initiatives, and projects from different individuals, groups, or department

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