Job was saved successfully.
Job was removed from Saved Jobs.

Job Details


Merck & Co, Inc

(Remote) Senior Specialist - Labeling, Regulatory Affairs (Infectious Disease and General Medicine) ( MERCUSR157592ENUS)

General

Foreign Affairs Specialist

Yearly

No

North Wales, Pennsylvania, United States

Job Description

New hires based in the US & Puerto Rico will be required to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption or accommodation to this vaccination requirement, subject to applicable law.

The purpose of the Global Labeling Therapeutic Area group is to drive labeling strategy and ensure high-quality and compliant labeling documents, which provide the safe and effective use of products for patients and healthcare providers globally. The Global Labeling Therapeutic Area group is accountable for developing labeling content and maintaining the target product labeling for developmental products, Core Labeling documents (e.g., CCDS, CCPPI, CCIFU) and US labeling for marketed products; and supporting country Regulatory Affairs in the development and maintenance of the EU Labeling and other country’s Local Labeling.

As part of the Global Labeling Therapeutic Area, and under the supervision of the Global Labeling Strategic Director, the GLL is responsible for:

  • developing, maintaining, and implementing Core Labeling for assigned products in line with internal standards and guidelines

  • developing, maintaining, and implementing US Labeling for assigned products in line with regulatory requirements and internal standards and guidelines

  • assisting with developing and maintaining Local Labeling (EU and most of world) for assigned products

  • providing labeling expertise and guidance to teams while ensuring compliance with applicable regulatory requirements

  • serving as regulatory labeling point of contact on global Regulatory Affairs sub-teams to ensure delivery of labeling documents that meet quality and compliance standards and regulatory labeling requirements to support timely regulatory submissions for assigned products

  • leading cross-functional teams to develop, review and approve Core and Local Labeling documents

  • recommending strategies and labeling language for inclusion in Core or Local Labeling during labeling development or responses to Health Authority

Competencies include:

  • Project management skills with the ability to handle multiple projects and prioritize work accordingly.

  • Tolerance for ambiguity and action- oriented.

  • Strong written and oral communication skills

  • Attention to detail and accuracy.

  • Ability to influence and negotiate.

  • Ability to distill an issue into critical components and suggest solutions

Requirements:

  • Bachelor’s degree in a scientific discipline is required. Advanced degree preferred (M.S., Pharm.D, Ph.D.).

  • Minimum of 3 years of labeling experience or relevant experience in the pharmaceutical industry (e.g., Medical Affairs, Regulatory Affairs, Clinical, Pharmacovigilance) preferred.

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.

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.

GRACSJOBS

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

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

EEOC Poster

EEOC GINA Supplement​

OFCCP EEO Supplement

Pay Transparency Nondiscrimination

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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:

No relocation

VISA Sponsorship:

No

Travel Requirements:

25%

Flexible Work Arrangements:

Remote Work

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID:R157592