Assoc Director, Global Data Management & Standards, Operational Excellence
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 Assoc Director is responsible for providing coordination and leadership support for internal audits as well as Global Health Authority Inspections, on behalf of GDMS. Incumbent will also play a key role in Serious Quality Issue investigations and related Corrective and Preventative Actions under the supervision of the Director, in compliance with Merck Standard Operating Procedures (SOPs).
- At least B.A. or B.S. degree, preferably in Pharmacy, Nursing, Biological Sciences, or health care related discipline.
- Minimum 8 years experience in Clinical Data Management or related industry experience preferred
- Strong knowledge of ICH and GCP guidelines
- Inspection experience
- Basic understanding of a quality management system
- Strong communication skills (written and oral communication)
- Strong sense of urgency and leadership abilities
- Ability to establish and maintain good working relationships with the different functional areas and work cross functionally as part of a team
- Ability to work under pressure
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.
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Job: Clinical Data Management
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings:
Shift (if applicable):
Company Trade Name: Merck