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Document Specialist, Regulatory Affairs CMC Job - United States  

Company managed [?] Still accepting applications

Posted on : 22 April 2017

Project Description

Document Specialist, Regulatory Affairs CMC-REG002860

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. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.


Individual Contributor, under the broad guidance of the Associate Director Regulatory Affairs, will be responsible for creation and maintenance of regulatory CMC documents in the official content management repository. Duties will include the set-up, workflow data entry, formatting and proofreading of chemistry, manufacturing and controls information for new marketing applications, post approval and maintenance submissions in a controlled document management system under the direction of CMC Regulatory Product Leads and/or Scientists. The candidate will collaborate with CMC Product Leads and/or Scientists to ensure Quality submission components are ready for publishing and delivered on time to meet project plans. The candidate will be accountable for adherence to standard operating procedures, internal guidance and data integrity of all assigned projects.

Qualifications

Education:

- Associates Degree in business/office management or equivalent experience working in a document management system

Required:

- Minimum 2 years’ experience working in a document management system

Preferred:

- Strong written/oral communication
- Fluent in English language

Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. 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.

Visa sponsorship is not available for this position.

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.


Job: Regulatory Affairs - CMC

Job Title:Assoc. Spclst, Regulatory Affairs-CMC

Primary Location: NA-US-NJ-Rahway

Other Locations: NA-US-PA-West Point

Employee Status: Regular

Travel: Yes, 10 % of the Time

Number of Openings: 2

Company Trade Name:Merck


Nearest Major Market: New York City
Nearest Secondary Market: Newark

Job Segment: Regulatory Affairs, Law, Copy Editor, Proofreading, Compliance, Legal, Creative