Label Document Controller Job

Employer
Merck
Location
West Point, PA, US
Posted
September 04 2017
Discipline
Other
Organization Type
Pharma
Label Document Controller-CLI006279

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.

Global Clinical Supply Packaging Operations is seeking a highly motivated individual to support clinical supply label production. The successful candidate should have working knowledge of clinical packaging operations including the understanding that all clinical supplies and associated documentation are processed according to Standard Operating Procedures, study protocols, GMP’s/GDP’s and appropriate Merck safety requirements to meet exacting standards defined by Merck, the FDA and EU or other international regulatory agencies.

Activities may include:

- Coordination of Label Translation Requests
- Generation of Clinical Label Proofs
- Liaise with country-level Clinical Operations personnel or Regulatory Affairs to request/ revise translations, address questions, update regulatory requirements, etc.
- Maintain Label Translations library
- Interpret clinical study designs and Clinical Supplies Specification documentation
- Understand and maintain study blinding
- Originate, design and verify label models in Clinical Supplies Labeling System
- Coordinate booklet label manufacturing at vendors
- Perform visual inspection and accountability for label proofs, clinical labels and Random Code Envelopes (RCE’s)
- Liaise with Clinical Supply Program Managers, Schedulers, Quality, Pharmaceutical Sciences, or other stakeholder
- Perform visual inspection and accountability for label proofs, clinical labels and RCE’s
- May represent Clinical Packaging on internal or cross-functional teams.

Qualifications

Education:

- Required:

- BA/BS Degree

- Preferred:

- Degree concentration in Sciences

Required:

- A minimum of 3 years of pharmaceutical industry experience
- Capable within Microsoft Office applications.
- Provide detailed analysis of issues and collaborate for creative problem solving
- Demonstrate strong communication and interpersonal skills to work in team environment
- Demonstrate excellent oral and written communication skills

Preferred:

- Previous Clinical Supply Operations experience
- Trained in SAP, Label Generation software (Clinical Supplies Labeling System) and other relevant systems

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:

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


Job: Clinical Supplies-Operations

Job Title:Spclst, Planning & Scheduling

Primary Location: NA-US-PA-West Point

Employee Status: Regular

Number of Openings: 1

Company Trade Name:Merck