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Clinical Safety Scientist at Merck USA in Rahway, NJ

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Description

Requisition ID: DRU000744

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 Clinical Safety Scientist (CSS) is responsible for support of safety reporting in clinical trials conducted in multiple therapeutic areas as part of investigational product development programs across early and late stage development.   In addition, the CSS will collaborate with cross-functional colleagues within clinical development, clinical operations, case processing and medical safety review. 

 

Oversees the activities of other Clinical Safety Scientists supporting the program or large trials and serves as a liaison with other cross-functional areas for safety reporting issues.  Serves as the subject matter expert for safety reporting in clinical trials with particular emphasis on the consistent application of standards and adherence to regulatory requirements for safety reporting in clinical trials.

 

May participate in and/or lead cross-functional initiatives.

Qualifications

Education:

  • BA/BS or equivalent Ex US degree in Life Sciences with 8+ years of work experience to include a minimum of 4 years relevant pharmaceutical, drug development/  health sciences, and/or drug safety experience.

OR

  • Advanced degree (M.S.)  or equivalent Ex US degree in Life Sciences with 6+ years of work experience to include a minimum of 4 years relevant pharmaceutical, drug development/  health sciences, and/or drug safety experience.

OR

  • M.D./D.O./ PhD  or equivalent Ex US degree in  Medicine,  with 3+ years of work experience to include a minimum of 2 years of experience in patient care setting  or  2 years relevant pharmaceutical, drug development, and/or drug safety experience.

Required:

  • Broad understanding of scientific and medical concepts
  • Experience in pharmaceutical drug development
  • Strong knowledge of GCP and ICH regulations
  • Demonstrated ability to work as part of a cross-functional team
  • Demonstrated ability to influence and collaborate internally across MRL at all levels and externally with business partners and vendors.
  • Ability to explain complex issues and work to build alignment and solutions
  • Role requires the ability to independently and proactively identify, appropriately escalate and plan for mitigations to potential problems, situations or issues within a study, program or key initiative.  Must be able to collaborate to resolve issues.
  • Demonstrated project management, and time management/organizational skills
  • Build team capabilities through proactive coaching. 
  • Provide guidance to team members/colleagues for functional area deliverables with emphasis on consistent application of TA or program specific requirements.
  • Strong communication skills with advanced oral and written English skills.
  • Advanced computer/database skills.

Preferred:

  • Experience in patient care setting.
  • Experience in drug safety.
  • Coaching and/or management skills

 

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 assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request tostaffingaadar@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.

 

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

 

            EEOC Poster

            EEOC GINA Supplement 



Job: Drug/Dvcs Sfty Survnce (NonMD)
Other Locations:
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: Merck

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