2018 MRL Regulatory Affairs Intern Job

West Point, PA, US
September 12 2017
Organization Type
2018 MRL Regulatory Affairs Intern:ADM008645


& 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

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

The Future Talent Program features
internships that last 10-12 weeks during the months of June-August, 2018. For the 2018 program, students who accept the
positions are responsible for housing costs. Five internship positions are
available in 2018 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 guidances, 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.



- Required: Candidates
must be currently pursuing a Master’s or Ph.D. degree in Regulatory
Sciences, Pharmaceutical Sciences,
or a related field
- Candidates
must be returning to school in the Fall of 2018.
- Candidates
must have completed at least (1) year towards MS degree program or PhD
program by June 2018.


- Candidates
must be available to work full-time for 10-12 weeks beginning in May or June
of 2018
- Candidates
must have a minimum GPA of 3.50
- Candidates must have strong personal character
and ethics
- Candidates must have superior communication and
interpersonal skills
- Candidates must have excellent academic
achievement and analytical thinking ability
- Candidates must be a good team player and be able
to work independently
- Good project management and organizational skills


- Proficiency
in Microsoft applications
- Experience writing, editing and reviewing
scientific content for regulatory filing

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

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

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



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

Other Locations: NA-US-NJ-Kenilworth

Job Type: Intern

Employee Status: Temporary

Travel: Yes, 5 % of the Time

Number of Openings: 5

Relocation Provided: None

Company Trade Name:Merck

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