Specialist, Worldwide Product Labeling- Labeling Operations and Compliance Job

Employer
Merck
Location
Gwynedd, PA, US
Posted
October 11 2017
Discipline
Other
Organization Type
Pharma
Specialist, Worldwide Product Labeling- Labeling Operations and Compliance:LAB000720

Description

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.

Under the direction of the Associate Director, Labeling US Operations and Compliance, is responsible for the proofreading of US labeling documents for new and in-line products, as well as the creation/audit/proof of the US Structured Product Labeling (SPL) documents for submissions and approvals. SPL activities include, but are not limited to:

- Prepares revised labeling packages for SPL creation in conjunction with our Merck partners and external SPL vendor

- Collects and reviews information pertinent to the manufacture and distribution of Merck’s products

- Reviews labeling packages for accuracy after creation

- Includes SPL packages in submissions

- Responsible for eListing of Content of Labeling SPLs after US approvals.

Effectively communicates requirements for launch of new products, and executes deliverables.

Qualifications

Education:

- Bachelor’s degree in a Scientific, Medical, or English/Journalism discipline

Required:

- At least two (2) years’ experience in the pharmaceutical industry or related field with knowledge of drug development.

- Excellent communication and organizational skills and proficiency in MS WORD required.

- Good interpersonal skills.

- Proven attention to detail.

- Demonstrated ability to manage multiple priorities.

- Strong conceptual and analytical thinking skills.

Preferred:

- Adobe Acrobat, Microsoft Office, Docu-Proof, Extensible Markup Language (XML)

- Proofreading/Editing experience desirable.

- Experience in product labeling/regulatory affairs or related discipline desirable.

Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.

If you need an accommodation for the application process please email us at staffingaadar@merck.com.

Search Firm Representatives Please Read Carefully:

Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

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

EEOC Poster

EEOC GINA Supplement​



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


Primary Location: NA-US-PA-Upper Gwynedd

Other Locations: NA-US-NJ-Rahway

Job Type: Full Time

Employee Status: Regular

Travel: Yes, 5 % of the Time

Number of Openings: 1

Alternative Work Arrangements Available: Flex Time,, Remote Work,, Telecommuting,

Relocation Provided: None

Company Trade Name:Merck

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