Job Description

Job Description

Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.

Primary Responsibilities:

* Manages and has responsibility for the functions of a team of Directors, Associate Directors and Senior Specialists in the review and approval of all US promotional materials and submission of such materials to FDA at time of dissemination.

* Oversees and acts as a resource in the development of promotional regulatory strategy and pre-clearance submissions and required negotiations with OPDP and/or APLB.

* Collaborates with Regulatory colleagues to ensure cohesive and integrated regulatory strategy from early development through approval and marketing.

* Works collaboratively with Commercial Operations, Legal and Compliance to develop, implement and communicate regulatory standards and policies to assist in the development of marketing and promotion materials that achieve business objectives while maintaining the highest quality and full compliance with the letter and spirit of relevant laws, FDA regulations and our Company's policies and guidelines.

* Assists in the development and implementation of department strategic initiatives. Ensures that direct reports are compliant with corporate policies and complete all required corporate and compliance training. Provide mentoring and promotional regulatory training to team members.

* Provide coaching and feedback to employees about both technical and leadership components of their work; engage with employees regarding development planning and performance management.

Minimum Education Requirements:

* B.A. or B.S. degree, advanced degree a plus/preferred

Required Education and Skills:

* Minimum 10 years experience in pharmaceutical/biologics marketing, clinical, medical, legal or regulatory disciplines

* Minimum 8 years experience working directly with or within marketing, promotion or marketing compliance.

* Minimum 5 years experience reviewing advertising and promotion materials or marketing programs for regulatory/legal compliance.

* In-depth understanding of FDA regulations and our Company's policies and procedures related to promotion development and implementation and promotion review processes.

* In-depth understanding of the clinical development process, including labeling development and FDA approval processes.

* Exercises a high degree of knowledge of FDA regulations relating to advertising and promotion.

* Demonstrated ability to lead and direct activities of a Team and work effectively in a team environment.

* Oncology and accelerated approval experience strongly preferred.

* Collaborative ability to perform cross-functionally.

* Superior verbal and written communication skills.

* Strong interpersonal and negotiation skills with ability to demonstrate strategic and analytic thinking.

* Demonstrate an ability to negotiate and influence others effectively.

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we follow the science that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

Who we are

We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

INVENT.

IMPACT.

INSPIRE.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

GRACSERP

US and Puerto Rico Residents Only:

If you need an accommodation for the application process please email us at staffingaadar@msd.com
For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement

OFCCP EEO Supplement

OFCCP Pay Transparency Rule

We are an equal opportunity employer, Minority/Female/Disability/Veteran proudly embracing diversity in all of its manifestations.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, 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.

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

Travel Requirements:

10%

Flexible Work Arrangements:

Flex Time

Shift:

Not Indicated

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1
Requisition ID:R91550