Our client, a growing publicly traded specialty pharmaceutical company in New Jersey, is seeking an Associate Director, Compliance.
- Provide timely and practical advice and support to the business related to compliance requirements, with a focus on medical device compliance requirements, with an understanding of how these requirements apply to the organization’s daily operations.
- Work closely with Legal and Compliance Department colleagues to provide consistent and efficient compliance support to the company in accordance with the company’s healthcare compliance policies and related laws, codes and regulations.
- Operationalize compliance policies by leading in the design, development, and implementation of SOPs and guidance documents in collaboration with cross-functional teams;
- Contribute to the development of the compliance training & communications plan, including annual training and communications strategies, plans, objectives, and schedule.
- Develop and deliver regular and ongoing Compliance training with strong facilitation skills through various avenues including live classroom training, virtual sessions, telephonic meetings, and national and regional field team meetings, in collaboration with the Learning and Development Department.
- Identify training gaps and develop and execute a plan for development of additional training programs, as required, based on prioritized needs in coordination with the Executive Director, Compliance and key stakeholders.
- Complete timely updates to training materials and create new training materials, as needed, acting as a subject matter expert to provide guidance in compliance with all legal, regulatory and business conduct standards.
- Manage the retention and organization of compliance training records.
- Assist with compliance audits, monitoring and internal investigations as needed while advising on appropriate corrective action.
- Assist with federal, state, and international transparency reporting obligations.
- Bachelor’s degree required;
- 8+ years of experience working as a compliance professional for a pharmaceutical and/or medical device manufacturer or within the life sciences industry;
- Compliance and Legal background with a strong business focus; law degree or masters is a plus.
- Demonstrated strong understanding of relevant federal, state and local laws, rules, and regulations as well as industry standards impacting U.S.-based pharmaceutical and medical device manufacturers, including: the Anti-Kickback Statute, the False Claims Act, the Food, Drug, and Cosmetic Act (FDCA), the Prescription Drug Marketing Act (PDMA), the Sunshine Act, the OIG Compliance Program Guidance, the PhRMA Code, and the AdvaMed Code.
- Demonstrated knowledge of enforcement landscape, including relevant industry investigations, litigation and settlements.
- 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.
- Strong grasp of relevant laws and FDA guidance regarding promotional labeling and advertising for drugs and devices is preferred.
- Knowledge of current laws, regulations and industry standards governing clinical trials, such as FDA regulations, ICH Guidelines, and GCPs is preferred.
- Ability to work well under pressure, to meet short deadlines, and to collaborate with cross-functional teams and key stakeholders;
- Excellent interpersonal skills and the ability to collaborate and communicate seamlessly with all levels;
- Excellent written and verbal English communication skills.
- Demonstrated excellent organizational skills.
- Excellent skill level in MS Office including Word, Excel and Outlook.