Director, Regulatory Legal

05 Sep, 2022

Jobs

Director, Regulatory Legal

Organon
Jersey City, NJ/Washington, DC/Annapolis, MD/Baltimore, MD/Columbia, MD/Frederick, MD/Laurel, MD/Cokesbury, NJ/Hackensack, NJ/Lebanon, NJ/Little Falls, NJ/Madison, NJ/Morristown, NJ/Mount Laurel, NJ/New Brunswick, NJ/Short Hills, NJ/Somerville, NJ/Trenton, NJ/Union, NJ/Bronx, NY/Brooklyn, NY/Manhattan, NY/Blue Bell, PA/Fort Washington, PA/Hanover Township, PA/Langhorne, PA/Lansdale, PA/New Castle, PA/North Wales, PA/Philadelphia, PA/Upper Gwynedd, PA/West Chester, PA/Wilkes Barre, PA/Alexandria, VA/Arlington, VA

Job Description

Organon is a Women’s Health Company that believes in a better and healthier every day for every woman! We are a passionate, global community of thousands dedicated to redefining the future of women’s health. Our mission is to deliver impactful medicines and solutions for a healthier every day. But what really makes it work at Organon is our people.

We’re looking for real, passionate team players, curious innovators, forward thinkers, empowered by the idea of shaping their career, and ready to bring their fire to embrace change and the opportunities it brings for progress.

At Organon, you’ll get to enjoy the best of both worlds: the open, agile, collaborative culture of a start-up, and operating at the scale of a Fortune 500 company with an international footprint that serves people in more than 140 markets.

It’s going to be an exciting future—come be a part of it!

Primary Responsibilities:

  • Advising the organization on FDA regulatory issues and compliance with laws, regulations, and applicable standards and policies throughout a drug or device’s lifecycle, including research, regulatory approvals or clearances, and advertising and promotion.
  • Provide legal support for drug and device advertising and promotional reviews as part of a cross-functional team.
  • Provide legal services, advice and guidance that is consistent with law and company policy; furthers business objectives and appropriately balances business objectives and legal risks.
  • Exercise judgment to drive decisions on routine and non-routine matters within area of practice.
  • Some domestic travel required (5%).

Education Minimum Requirements:

  • A bachelor’s degree from an accredited institution.
  • JD degree, required. Graduate of an accredited U.S. law school, with admission to the Bar of New Jersey or another state.

Required Experience and Skills:

  • 4+ years of legal experience in a law firm or corporate setting.
  • In both pharmaceutical products and medical devices is a plus.
  • Experience in managing a significant workload, with the ability to juggle multiple assignments simultaneously.
  • Ability to work independently with high degree of initiative and intellectual curiosity.
  • Ability to be proactive and take initiative.
  • Excellent teamwork, communication (written and oral) and analytical skills, and a high degree of business acumen.

Preferred Experience and Skills:

  • In product liability litigation and business counseling.

Who We Are:

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions.  Our Vision is clear: A better and healthier every day for every woman.

Subject to applicable law, all prospective US Organon hires will be required to demonstrate that they have been fully vaccinated against COVID-19 with a vaccine authorized or approved by the Food and Drug Administration (FDA), or qualify for a medical or religious accommodation to this vaccination requirement, as a precondition of employment.

Residents of Colorado: to request this role’s pay range:  email: coloradopayact@organon.com

Jersey City and New York City Positions:  to request this role’s pay range and benefits, email: jcnycpayact@organon.com

US and PR Residents Only

If you require reasonable accommodation(s) in completing an application, interviewing, or otherwise participating in the employee selection process, please email us at staffingaadar@organon.com.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement

OFCCP EEO Supplement

OFCCP Pay Transparency Rule

Organon is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

Search Firm Representatives Please Read Carefully 
Organon LLC., does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Learn more here

Job posted: 2022-09-05