Global Genomics Policy, Process and Clinical Compliance Job - United States
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. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
This role is for an Associate Principal Scientist in Global Genomics Policy, Process and Compliance (GPPC), which reports into the Clinical Pharmacogenomics and Operations group in the Genetics and Pharmacogenomics (GpGx) department within Translational Medicine.
GPPC is responsible for understanding and ensuring compliance with global policies and regulation pertaining to genomic/biomarker research and biobanking; developing MRL policies related to genomic research and biobanking; and ensuring compliant use of biospecimens from MRL clinical trials. The Associate Principal Scientist in GPPC will be responsible for assisting the Head of GPPC in these activities and will interact with multiple stakeholders inside and outside of the company. This is an individual contributer role.
MAJOR ACTIVITIES AND RESPONSIBILITIES:
- Applies knowledge of clinical drug development, GCP requirements, and global policies/laws/regulations to ensure proper usage of MRL biospecimens, particularly for genomic research
- Oversees genomic/biomarker patient consent processes, including negotiation and tracking
- Assists in the management of external vendor engaged in study-specific genomic/biomarker consent development, negotiation and review
- Oversees documentation of processes (including job aides 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 work groups. May lead/manage project teams
- Assists in the development of genomic and biomarker language for MRL 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 with documentation standards.
- BS Degree in Biological Sciences or related discipline with at least 8 years OR MS Degree in Biological Sciences or related discipline with at least 3 years of related experience
- Master’s or Doctoral degree
- 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
- Clinical experience such as clinical trial management; clinical scientist; protocol or consent authoring
- 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
- Knowledge of GCP, ICH guidelines and regulatory requirements
- Knowledge of global policies, laws, regulations pertaining to genomic research and biobanking
- Working scientific knowledge of genomic research
Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at firstname.lastname@example.org.
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Job: Clinical Research (Non-M.D.)
Job Title:Assoc Prin. Scientist, Clinical Research
Primary Location: NA-US-NJ-Kenilworth
Other Locations: NA-US-PA-Upper Gwynedd, NA-US-PA-West Point, NA-US-NJ-Rahway
Employee Status: Regular
Travel: Yes, 15 % of the Time
Number of Openings: 1
Company Trade Name:Merck
Nearest Major Market: New York City
Nearest Secondary Market: Newark
Job Segment: Clinic, Genetics, Medical, Compliance, Law, Healthcare, Science, Legal