Job Details

Company Description

Sentynl Therapeutics, a wholly owned subsidiary of Zydus Lifesciences Ltd., is a commercial-stage biopharmaceutical company dedicated to delivering innovative therapies to patients with rare diseases. With an emphasis on commercialization, Sentynl looks to acquire, develop, and commercialize well-differentiated products across a broad spectrum of therapeutic areas to address a variety of genetic, orphan, and neurological disorders.

To support its latest acquisitions, Sentynl is searching for a Compliance Manager working a hybrid schedule office environment in Solana Beach, CA (San Diego county).

Role Description

The Compliance Manager will support Sentynl's Compliance and Legal Departments in various areas, including but not limited to conducting auditing and monitoring; drafting, updating, and maintaining compliance policies and trainings; circulating legal hold orders; maintaining legal and compliance records; and scheduling Compliance Committee, Independent Grant Review Committee, and other meetings. The ideal candidate will have a health care/life sciences compliance background. The candidate will report to the Associate General Counsel, Senior Director of Compliance.

Key Responsibilities:

Compliance:

• Monitors compliance by performing routine analytics of relevant data and conducting field ride-alongs with Sentynl sales professionals and Medical Science Liaisons
• Audits internal records and third parties
• Maintains key healthcare compliance-controlled documents, including the company's Compliance Manual, policies, SOPs, and training materials
• Creates, delivers, and tracks compliance training through a combination of online tools and live training
• Assists with maintaining the company's data privacy program, including drafting and maintaining policies, creating and delivering trainings, and auditing and monitoring
• Assists Compliance with compilation of data for Open Payments reporting
• Conduct and track exclusion-list screenings for vendors

Legal:

• Supports Legal Department needs, including contract management, legal research, creating trainings, and maintaining training records
• Assists with administering the company's records-management program
• Supports Legal and Compliance Department scheduling, including internal and external business meetings and formal meetings, including Compliance Committee meetings
• Supports Independent Grant Review Committee, including scheduling meetings, assisting with presentation materials, and preparing meeting minutes
• Assists with drafting meeting minutes and notes for internal and external meetings

Qualifications

• Education: Bachelor's degree required, paralegal certificate preferred
• Experience: Minimum of five (5) years of relevant experience in Compliance and/or Legal in the biopharmaceutical industry
• Highest level of professional ethics and integrity
• Ability to handle confidential matters and exercise sound discretion and judgment
• Ability to identify potential compliance issues and communicate issues to others
• Superior written and verbal communication skills
• Strong attention to detail
• Demonstrated ability to work independently and manage multiple projects that require collaboration across functional areas
• Highly skilled at Microsoft Office (MS Word, PowerPoint, Excel, Outlook)
• Success in prior Compliance Manager or equivalent role at a life sciences company

Work Environment:

• The preferred candidate will be local to the Solana Beach, CA office or willing to relocate
• The work environment characteristics described here are representative of those individual encounters while performing the essential functions of this job
• Normal office conditions
• Routine travel will be required between various locations in US and occasional international travel. Up to 20% travel.

Core Values & Competencies:

Time Management

· Completes assignments and projects accurately and on time

· Sets clear and achievable long- and short-term goals

· Shows ability to prioritize between urgent and important tasks

Compliance

· Alignment with company Code of Conduct

· Ensures regulatory conformance

· Adherence to international standards

Collaboration

· Open communication

· Mutual trust

· Shared accountability

Problem Solving

· Results oriented

· Analytical thinking and root cause identification

· Critical thinking

Engagement

· Alignment with company values

· Demonstrates extra effort to achieve results

· Displays genuine interest in the job

Motivation/Teamwork

· Acts as a trustworthy team member

· Demonstrates dependability in all situations

· Shows resiliency and maintains a positive attitude in all situations

Sentynl Therapeutics, Inc. offers a competitive salary program and an attractive benefits package that includes:

• The base salary for the Compliance Manager will be $120K to $140K plus 20% bonus
• Medical/Dental/Vision Insurance
• Company paid Life Insurance, Short-term Disability and Long-term Disability
• 401(k) plan with a generous employer match
• Unlimited PTO – based upon our trust of employees to manage their work schedule and mutual agreement between the employee and their manager
• Paid holidays