Merck Senior Scientist, Global Genomic Policy, Process and Compliance in Kenilworth, New Jersey
This role is for a Senior Scientist in Global Genomics Policy, Process and Compliance (GPPC), which reports into Genetics and Pharmacogenomics (GpGx) within Translational Medicine. GPPC is responsible for understanding and ensuring compliance with global policies and regulations pertaining to genomic/biomarker research and biobanking; developing our research lab policies related to genomic research and biobanking and ensuring compliant use of biospecimens from our company's research lab clinical trials. The Senior Scientist in GPPC will be responsible for assisting GPPC colleagues in these activities as well as spearheading process initiatives to ensure compliance and increase efficiency. As an individual contributor, the Senior Scientist will interact with multiple stakeholders inside and outside of the company.
MAJOR ACTIVITIES AND RESPONSIBILITIES:
Applies knowledge of clinical drug development, Good Clinical Practices (GCP) requirements, and global policies/laws/regulations to ensure proper usage of our research lab biospecimens, particularly for genomic research
Assists with genomic/biomarker patient consent processes, including negotiation of consent language and tracking of consent restrictions
Assists in process development and maintenance of external vendor engaged in study-specific genomic/biomarker consent development, negotiation and review
Assists with documentation of processes (including job aids and SOPs) as well as other documents necessary for department activities
Direct point of contact for multiple stakeholders within the company for questions related to genomic and biomarker consent
Collaborates and communicates within and across stakeholder workgroups. May lead/manage project teams
Assists in the development of genomic and biomarker language for our research lab protocols and consents
Makes decisions that require choosing between limited alternatives to resolve problems of moderate to high complexity. Works in a structured environment under moderate supervision. Maintains accurate records of ongoing projects in adherence to documentation standards.
Position Qualifications :
Education Minimum Requirement:
Degree in Biological Sciences or related discipline.
BS with at least 8 years or MS with 3-5 years of related experience
Master’s or Doctoral degree preferred
Required Experience and Skills:
Clinical research experience such as clinical trial management; clinical scientist; protocol or consent authoring required
Knowledge of International Conference on Harmonisation Good Clinical Practice (GCP, ICH) guidelines and regulatory requirements a must
Currently demonstrates or is able to quickly develop a working scientific knowledge of different therapeutic areas and of genomic research
Ability to manage complex operations and projects under accelerated timelines
Scientific, medical and/or safety writing and reporting (at least one is required)
Ability to partner effectively with internal and external (CRO) teams to achieve results
Strong team collaboration, leadership, communication (written and verbal), issue identification and resolution skills
Preferred Experience and Skills:
Knowledge of global policies, laws, regulations pertaining to genomic research and biobanking is highly desired
Experience working with Laboratory Information Management System
Working scientific knowledge of genomic research a plus
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
Who we are …
Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.
We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.
What we look for …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
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OFCCP Pay Transparency Rule at https://www.dol.gov/ofccp/pdf/pay-transp%20EnglishformattedESQA508c.pdf
We are an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Flexible Work Arrangements:
Valid Driving License:
Number of Openings:
Requisition ID: R56945
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