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2017 Regulatory Affairs Intern Job

Employer
Merck
Location
West Point PA
Closing date
Feb 20, 2017

Job Details

2017 Regulatory Affairs Intern:ADM008008

Description

Merck & Co., Inc. Kenilworth, NJ, 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.


The Future Talent Program features internships lasts 10-12 weeks during the months of June-August, 2017. For the 2017 program, students who accept the positions are responsible for housing costs. Three internship positions are available in 2017 in the Regulatory Sciences (CMC) group based at our West Point, PA site. The Regulatory Sciences organization strives to improve public health by enabling access to Merck medicines and vaccines worldwide. It supports every step of the CMC strategy, submission and liaison through all phases of the product lifecycle: Early Development, Commercialization and Supply. The Regulatory CMC department is seeking summer interns interested in enhancing core knowledge and applied critical thinking skills in the regulatory CMC field. This opportunity will expose the intern to all areas of the department and provide beneficial experience and understanding of Regulatory CMC processes:

- Understand regulatory compliance of manufacture and release of investigational products for clinical use. Determine requirements for export/import of investigational products.

- Understand specification requirements for testing of drug substance/drug product/ raw materials in compliance with regulatory requirements.

- Review completeness of documentation to support IND/CTA/NDA/BLA/MAA submissions (according to “refuse-to-file” guidelines). Assemble CMC documentation for submission.

- Apply regulatory requirements for manufacturing /quality system and compliance with cGMPs.

- Understand manufacturing changes to ensure compliance with appropriate change control systems/process and determine regulatory filing strategy (PAS, CBE, Annual Reports, etc).

- The intern will work closely with Regulatory CMC personnel to assist with assembling CMC documentation for submission, assess the regulatory environment (current/pending guidance's, regulations, HA/industry initiatives), acquire and apply filing knowledge and requirements (national, international) and also evaluate manufacturing changes for compliance with appropriate change control systems/process.

Qualifications

Education:

- Required: Currently pursuing a MS/Ph.D. degree in Regulatory Sciences or Pharmaceutical Sciences.

- Must have completed at least 1 year towards MS degree program or PhD program by June 2017.

- Must be returning to school in Fall 2017.

Required Experience:

- GPA of 3.5 or higher

- Strong personal character and ethics

- Superior communication and interpersonal skills

- Excellent academic achievement and analytical thinking ability

- Good team player and ability to work independently

- A letter of reference from a professor is highly recommended; you may attach it in the same section of the profile as your resume

- Must be available for full time employment for 9-12 weeks during the months of June-August

Preferred Experience:

- Good project management and organizational skills

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.


Primary Location: NA-US-PA-West Point

Job Type: Intern

Employee Status: Temporary

Number of Openings: 3

Relocation Provided: None

Company Trade Name:Merck

Company

Our vision is to make a difference in the lives of people globally through our innovative medicines, vaccines, biologic therapies, consumer health and animal products. We aspire to be the best healthcare company in the world and are dedicated to providing leading innovations and solutions for tomorrow.

We have made it our mission to provide innovative, distinctive products and services that save and improve lives, satisfy customer needs and to be recognized as a great place to work

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