Position Summary:
Catalent’s Somerset, NJ location is Catalent’s HQ and is home to oral solid dose manufacturing operations as part of the Oral and Specialty Delivery (OSD) business unit. On site we have our state-of-the-art laboratory, clinical, and commercial manufacturing plant for oral dose forms in addition to being the Catalent Center of Excellence for handling Highly Potent Active Pharmaceutical Ingredients.
Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.
The Compliance Specialist will assist with the continuous strategic development and implementation of Catalent’s global corporate compliance program to ensure adherence to compliance requirements, laws, regulations, and prudent business practices. The role will involve a special emphasis on supporting internal investigations and risk assessments, developing compliance education and training materials, and refining corporate compliance policies. The Compliance Specialist will report to the Assistant General Counsel, Compliance & Litigation, who serves as lead manager of the Company’s corporate compliance program and as head of the company’s commercial litigation and dispute resolution group. The role will also work closely with other members of the Legal & Compliance Department’s Ethics & Compliance group.
Primary Location: Somerset, NJ (open to candidates in surrounding area)
Schedule: Hybrid
The Role:
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Support Catalent’s global compliance program by: developing training content for internal client groups; assisting with the initiatives of Catalent’s Compliance Champions and Compliance Council; supporting programmatic adjustments required to meet evolving standards including privacy laws and the EU Whistleblower Directive; and responding to third-party correspondence regarding compliance evaluations and monitoring.
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Maintain the company’s online platform cataloguing investigations of alleged violations of company policy or the law, including complaints received through Catalent’s Business Conduct Helpline, and assist in the preparation of reports that track and analyze corresponding trends.
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Draft written responses to inquiries received by the Ethics & Compliance group regarding Catalent’s Standards of Business Conduct, issue-spotting legal and regulatory concerns and identifying ways to mitigate compliance risk.
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Monitor and interpret legal, regulatory, and policy changes affecting the company and evaluate the potential impact those requirements may have by reviewing policies and procedures as they relate to compliance activities.
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Other duties as assigned
The Candidate:
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Bachelor’s Degree
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Minimum 1 year experience in corporate compliance, legal, or internal audit environment. Corporate legal department experience at a company in the pharmaceutical or biotechnology industries or commercial litigation experience at a well-reputed law firm is a strong plus.
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Ability to maintain the confidentiality of privileged material.
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Outstanding written and oral communication skills, with an ability to gather data, synthesize complex compliance issues, and prepare cogent and succinct reports for internal clients.
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Ability to function effectively and efficiently in a fast-paced and dynamic environment while simultaneously managing multiple time-sensitive projects.
Why you should join Catalent:
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Defined career path and annual performance review and feedback process
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Diverse, inclusive culture
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19 days of PTO + 8 paid holidays
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Several Employee Resource Groups focusing on D&I
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Dynamic, fast-paced work environment
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Employee Stock Purchase Program
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.
