Director, Compliance

Job Description :

As a privately-owned, biopharmaceutical company, Ferring pioneers and delivers life-changing therapies that help people build families and live better lives.

Our independence helps us cultivate an entrepreneurial spirit and long-term perspective that enables us to achieve growth and scale, while remaining agile and true to our people first’ philosophy.

Built on a 70-year plus commitment to science and research, Ferring is relentless in its pursuit of science that drives powerful discoveries and therapies to help people build families, stay healthy, and stand up to the world’s oldest enemy : disease.

Ferring is on a mission to transform the treatment of bladder cancer with a novel, first-in-class intravesical gene therapy that provides patients with an alternative to bladder removal surgery.

Our Uro-Oncology team is growing with a variety of rewarding opportunities in commercial, medical affairs and technical operations.

If you are energized by the prospect of bringing the benefits of cutting-edge science to meet the needs of patients, we may have the perfect role for you.

As the Director, Compliance you will create risk-based compliance strategies and ensure comprehensive compliance support of assigned functions within our Uro-Oncology organization.

This is your opportunity to play an important role in making available to patients a novel product that has the potential to revolutionize the treatment of bladder cancer!

With Ferring, you will be joining a recognized leader, identified as one of The World’s Most Innovative Companies by , and honored by with inclusion on its Change the World List, for addressing society’s unmet needs.

Ferring US is also Great Places to Work® Certified, distinguishing it as one of the best companies to work for in the country.

Responsibilities

• Independently provide compliance guidance on promotional and non-promotional materials, scientific exchange, disease state, medical / scientific programs and R&D activities to minimize company risk and facilitate compliance that is in alignment with applicable regulations.
• Develop and execute an engagement and integration plan in symphony with other Compliance Associate Directors as well Compliance Directors for US Compliance to incorporate requirements and training into commercial operations, and vendors, based on identified gap analyses and risks assessments or potential areas of compliance vulnerability.
• Embrace and implement opportunities to 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.
• Foster a company culture that focuses on compliance and ensures on-going commitment to the Ferring Philosophy
• Act as the Compliance lead for : business support teams, including Legal, Regulatory, and Human Resources, to establish requirements and guidelines in support of non-commercial employees.

Uro-Oncology commercial and non-commercial teams. Provide input on compliance matters to live during in person and virtual meetings or via written materials to for key stakeholders and senior leadership.

the evaluation and implementation of SOPs, policies, and training as well as contribute to related standards and guidelines for concept and activity reviews to field implementation.

• Monitor commercial and non-commercial programs and business processes to ensure adherence to company’s policies and procedures in a manner that is consistent with best practices and applicable laws and guidance.
• Develop and implement or update policies, SOPs, guidelines, and associated internal communications related to non-promotional, medical / clinical programs, including congress activity, educational programs, use of publications and reprints, commercial medical interactions, advisory boards, ad hoc consulting, IITs, clinical trials, Mock FDA meetings, etc.
• Review and approve annual engagement plans and business need reviews for HCP engagements and other interactions incoming from the Commercial Operations, Sales and Marketing departments of all Business Units
• Act as a representative on select cross functional teams or Committees as assigned for matters relating to Commercial Compliance including task forces.

Requirements :

• Minimum 10 years of Compliance, Legal Regulatory or related work experience, with at least 5 years’ in the pharmaceutical industry.
• Bachelor’s degree required, advanced degree preferred.
• Demonstrated experience supporting complex products in oncology, rare disease, buy & bill, medical device, or injectables.
• In depth understanding of PhRMA Code; Federal Food, Drug, Cosmetic Act; Anti-Kickback Statute; and federal and state transparency and disclosure laws.
• Knowledge of industry compliance activities, regulatory landscape, pharmaceutical compliance training and monitoring programs.
• Demonstrated experience and creating and delivering effective compliance training
• Strong interpersonal skills, platform skills, and written and verbal communication skills
• Experience with implementation of risked-based compliance programs and understanding of US pharmaceutical / device and other regulations.
• Works well across multiple functions and therapeutic areas
• Demonstrated ability to develop, launch, deliver, and measure various forms of training
• Proficient technology skills, etc.
• Position requires excellent written and verbal communication, motivational, interpersonal and time management skills.
• Travel 20-30%

Ferring + you

At Ferring, we offer competitive total compensation along with an exceptional range of flexible benefits, personal support and tailored learning and development opportunities all designed to help you realize your full potential both in life and at work.

From working hours that respect your lifestyle, a culture that is welcoming and equitable, and the chance to work with the industry’s most impressive people, these are just some of the ways we live our "People First" philosophy.

Our Compensation and Benefits

At Ferring, base salary is one part of our competitive total compensation and benefits package and is determined using a salary range.

The base salary range for this role is $174,000 to $254,150, which is the reasonable estimate of the base compensation for this role.

The actual amount paid may differ based on non-discriminatory factors such as experience, knowledge, skills, abilities, education and primary work location.

Additional compensation for this role will be provided based on competitive annual incentive compensation targets in the form of an annual bonus - payouts are based on individual and company performance.

• Benefits for this role include : comprehensive healthcare (medical, dental, and vision) with a premium differential, inverse to base salary, to be paid by employees;
• a 401k plan and company match; short and long-term disability coverage; basic life insurance; wellness benefits; reimbursement for certain tuition expenses;

sick time frontloaded yearly of 40 hours, or higher if state or local law requires; vacation time for full time employees to accrue between 112.

5 and 150 hours yearly in the first four (4) years of employment, and additional accruals starting in the fifth (5th) year of employment;

and 12 to 13 paid holidays per year. We are proud to offer 26 weeks of paid parental leave, learn more about the parental leave offering in our benefits package .

For roles that are not field-based, Ferring has a policy that allows employees to work up to two days from home and three at a Ferring site, weekly.

Ferring is an equal opportunity employer. All aspects of employment will be based on merit, competence, performance, and business needs.

We do not discriminate on the basis of gender, race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local laws.

Join our team and your voice will be heard, and your contributions will be valued. If you love to come up with new ways to make a positive difference and see them through, you will fit right in.

We are proud to be an Affirmative Action / Equal Opportunity Employer (including Disability / Protected Veterans). We maintain a drug-free workplace.

Location :

Parsippany, New Jersey