2018 MRL Regulatory Affairs Intern

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 Statesand Canada, is a global health care leader with a diversified portfolio ofprescription medicines, vaccines and animal health products. The differencebetween potential and achievement lies in the spark that fuels innovation andinventiveness; this is the space where Merck has codified its legacy forover a century. Merck’s success is backed by ethical integrity, forwardmomentum, and an inspiring mission to achieve new milestones in globalhealthcare.


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 downon this goal. Merck Research Laboratories is a true scientific researchfacility of tomorrow, and will take Merck’s leading discovery capabilities andworld-class small molecule and biologics R&D expertise to createbreakthrough science that radically changes the way we approach seriousdiseases.

The Future Talent Program featuresinternships that last 10-12 weeks during the months of June-August, 2018.  For the 2018 program, students who accept thepositions are responsible for housing costs. Five internship positions areavailable in 2018 in the Regulatory Sciences (CMC) group based at our WestPoint, PA site. The Regulatory Sciences organization strives to improve publichealth 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 andSupply. The Regulatory CMC department is seeking summer interns interested inenhancing core knowledge and applied critical thinking skills in the regulatoryCMC field. This opportunity will expose the intern to all areas of thedepartment and provide beneficial experience and understanding of RegulatoryCMC processes:

  • Understand regulatory compliance ofmanufacture and release of investigational products for clinical use.
  • Determine requirements forexport/import of investigational products.
  • Understand specificationrequirements for testing of drug substance/drug product/ raw materials incompliance with regulatory requirements.
  • Review completeness of documentationto support IND/CTA/NDA/BLA/MAA submissions (according to “refuse-to-file”guidelines). Assemble CMC documentation for submission.
  • Apply regulatory requirements formanufacturing /quality system and compliance with cGMPs.
  • Understand manufacturing changes toensure compliance with appropriate change control systems/process and determineregulatory filing strategy (PAS, CBE, Annual Reports, etc).

The intern will work closely with Regulatory CMCpersonnel to assist with assembling CMC documentation for submission, assessthe regulatory environment (current/pending guidances, regulations, HA/industryinitiatives), acquire and apply filing knowledge and requirements (national,international) and also evaluate manufacturing changes for compliance withappropriate 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.
  • RequiredExperience:

  • 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 characterand ethics
  • Candidates must have superior communication andinterpersonal skills
  • Candidates must have excellent academicachievement and analytical thinking ability
  • Candidates must be a good team player and be ableto work independently
  • Good project management and organizational skills
  • PreferredExperience:

  • Proficiencyin Microsoft applications
  • Experience writing, editing and reviewingscientific content for regulatory filing
  • A letter of reference from a professor is highlyrecommended; you may attach it in the same section of the profile as yourresume.


    Your role at Merck isintegral to helping the world meet new breakthroughs that affect generations tocome, and we’re counting on your skills and inventiveness to help makemeaningful contributions to global medical advancement. At Merck, we’reinventing for life. 

     

    If you need anaccommodation for the application process please email us atstaffingaadar@merck.com.

      

    Search FirmRepresentatives Please Read Carefully: 

    Merck & Co., Inc. isnot accepting unsolicited assistance from search firms for this employmentopportunity.  Please, no phone calls or emails.  All resumessubmitted by search firms to any employee at Merck via email, the Internet orin any form and/or method without a valid written search agreement in place forthis position will be deemed the sole property of Merck.  No fee will bepaid in the event the candidate is hired by Merck as a result of the referralor through other means.

     

    Visa sponsorship is notavailable for this position.

     

    For more informationabout personal rights under Equal Employment Opportunity, visit:

     

                EEOC Poster

                EEOC GINASupplement 

     

    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

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