2018 MRL Regulatory Affairs Intern Job

Employer
Merck
Location
West Point, PA, US
Posted
October 12 2017
Organization Type
Pharma
Requisition ID: ADM008645

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.


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.

Qualifications

Education:

  • 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.


  • Required
    Experience:



  • 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


  • Preferred
    Experience:



  • 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
    resume.


    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.



     



    Visa sponsorship is not
    available for this position.



     



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



     



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    FTP2018



    Job: Administrative Svcs Generic
    Other Locations:
    Employee Status: Temporary
    Travel: Yes, 5 % of the Time
    Number of Openings:
    Shift (if applicable):
    Hazardous Materials:
    Company Trade Name: Merck