Associate Director, Compliance

About Pharming

Pharming Group N.V. (Nasdaq: PHAR/Euronext Amsterdam: PHARM) is a global biopharmaceutical company dedicated to transforming the lives of patients with rare, debilitating, and life-threatening diseases. Pharming is commercializing and developing an innovative portfolio of protein replacement therapies and precision medicines, including small molecules, biologics, and gene therapies that are in early to late-stage development. Pharming is headquartered in Leiden, Netherlands, and has employees around the globe who serve patients in over 30 markets in North America, Europe, the Middle East, Africa, and Asia Pacific.

Our Culture

Pharming is committed to our core values: "We Care, We Collaborate, We Walk the Talk", which is complementary to our focus on self-development of our people, teamwork, leadership and being results orientated. In our growing organization, it is important that employees feel connected and engaged. Our core values enable our mission of bringing the unserved rare disease patients the solutions they need and create a clear pathway forward to meet our strategic goals and objectives.

Overview

Pharming is seeking to hire an Associate Director, Compliance to bring risk-based and comprehensive compliance strategies across Pharming's Commercial Sales, Market Access, Marketing, Medical and/or other related functions to provide guidance that will impact how key stakeholders will interact with customers and HCPs. Our goal is to have this individual help in leading the development, implementation, and continuous improvement of an effective compliance program. Successful execution will involve working collaboratively with Compliance leadership to ensure their areas of responsibility are aligned with Pharming's US Compliance program strategy and is effectively implemented, managed, and executed by Pharming personnel to prevent violations of applicable laws, regulations, industry codes, and policies that govern our Compliance program.

Key Responsibilities

The Associate Director, Compliance will be responsible for a wide variety of matters in support of Pharming's growth as we increase the number of both pipeline and marketed products.

Core functions include:

* Lead and direct management and oversight of US policies and procedures. This will include educating and influencing key stakeholders about new requirements during the development of new documents and updates to existing documents to meet the changing nature of business activities as well as the routine maintenance of effective control documents to ensure Pharming personnel have the resources to remain compliant.* Lead the development and implementation of compliance training and education for US employees to ensure effective understanding and compliance.* Oversight of the US portion of the Pharming Hotline and investigations including independently evaluating hotline and other source reports, conducting appropriate investigations and outcomes, and assisting with determining appropriate corrective action when necessary.* Management and maintenance of the US Disclosure log, including analyzing data to determine trends, risks and reporting to senior management at regular intervals.* Manage Healthcare Professional and Healthcare Institution engagement process for all HCP engagements by the Medical, Market Access and Commercial organization. Review and approve annual engagement plans and business need reviews for HCP and HCI engagements and other interactions incoming from the commercial, medical, and R&D functions.* Manage the Fair Market Value process for all HCP engagements, train stakeholders, review requests and determine appropriate tiering of HCPs.* Collaborate and assist on the following aspects of the compliance program:* Compliance communications.* Compliance Leadership engagement.* Risk Assessment and Monitoring.* Government Transparency Reporting.* Vendor management.* Enforcing Compliance Standard

* Partner with key stakeholders to independently advise, provide guidance on promotional and non-promotional materials and activities, scientific exchange, disease state, medical/scientific programs, and R&D activities to minimize company risk and facilitate compliance that is in alignment with applicable regulation.* Provide clarity around policies and procedures required to ensure the complaint functionality of the commercial, medical, R&D, and other departments and personnel in their daily interactions with healthcare professionals, institutions, payors, and other groups.* Collaborate with Global Compliance Colleagues to align activities, projects and initiatives with Pharming global Compliance standards, processes, and objectives. Identify compliance risk areas and create and implement novel approaches and action plans to address and mitigate the risk.* Seek and embrace opportunities to evaluate and rethink how Compliance services are provided, focusing internal expertise on complex, high value matters, and automating, streamlining, or outsourcing high-volume, lower complexity matters, and using data to drive continuous improvement in services.* Act as a representative on select cross functional teams or Committees as assigned for matters relating to Commercial Compliance including task forces. Contribute to the discovery, development, and delivery of our products to our patients and customers* This is a hybrid role; must be able to report to the Warren, NJ office, 2 to 3 days per week.

Minimum Qualifications

* Master's Degree with 4+ years of relevant experience OR Bachelor's Degree with 8+ years' experience.* 3+ years' experience in Compliance focused on activities within Commercial Sales, Market Access, Marketing, and Medical for the pharma/biotech industry.

Preferred Qualifications

* Experience identifying, creating, and implementing novel approaches to mitigate risk.* Commitment to ethical conduct; ability to handle confidential and proprietary information using excellent discretion and judgment.* Strong interpersonal skills with ability to develop and maintain effective cross-functional relationships with stakeholders.* Excellent communication skills, both written and verbal.* Ability to work both independently and collaboratively.

Salary Range

Pharming takes into consideration a combination of candidate's work experience, training, and education, as well as the scope of the role, complexity, and external market and internal value when determining a salary level.

The base salary range for this job is from $140,000 to $160,000 per year.

Compensation & Benefits

* Flexible hybrid work schedule to promote a health work-life balance.* Competitive compensation package including annual target bonus.* Long-Term Incentive Program* 401(k) plan with company match* Paid-Time Off Days* 16 Company Holidays per year (typically last week of December up until New Year's Day)

Other Benefits

* Excellent Healthcare Plans including Medical, Dental and Vision.* Flexible Spending Accounts for Medical and Dependent Care.* Company-provided Life Insurance, Short-Term and Long-Term Disability Plans.* Accident, Hospital Indemnity and Critical Illness Plans.* Pet Insurance Plan.* On Premise Fitness Center.* Health & Wellness Program.* Choice of Mobile Phone for Work Use or Cell Phone Stipend.* Pharming Academy - Continuing Learning & Development Program.

Additional Information

Pharming is committed as an Equal Opportunity and Affirmative Action employer for all employees and qualified applicants without regard to race, color, sex, gender identity or expression, genetic information, sexual orientation, marital status, race, religion, color, national origin, disability, protected Veteran status, age, or any other characteristic protected under applicable law.

An applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request via email to HR-US@pharming.com.

Unsolicited resumes from agencies should not be forwarded to Pharming. Pharming will not be responsible for any fees arising from the use of resumes through this source. Pharming will only pay a fee to agencies if a formal agreement between Pharming and the agency has been established. The Human Resources/Talent Acquisition department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.

Please note that we review every submission, and we will keep submissions on file for six months. #J-18808-Ljbffr