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Tata Consultancy Services in Rahway, NJ is seeking a Regulatory Documentation Professional to support the creation, management, and strategy of procedural documents for the GRACS organization within Merck Research Laboratories. The role collaborates with process leads and SMEs to ensure documentation reflects intended processes for regulatory and pharmacovigilance activities.
Salary range is $130,000–$150,000 per year with comprehensive benefits; requires a Bachelor of Computer Science and
Supports the operational aspects of procedural documentation creation, management and advises on process documentation strategy for Merck’sGlobal Regulatory Affairs & Clinical Safety (GRACS) organization within Merck Research Laboratories (MRL). The role is responsible for GRACS enterprise-wide, centralized project management leadership and coordination supporting the GRACS Business System Owners, Global Process Leads and Functional Areas in the development, revision, implementation and maintenance of their procedural documentation (policies, standard operating procedures and supporting documents) related to global Regulatory Affairs and/or Pharmacovigilance activities. Conducts large and small-scale business impact assessments while working key project stakeholders and process owners to ensure project outcomes meet business and compliance requirements. The role collaborates with Global Process Leads, Business System Owners, Functional Leads, Document Owners, and Subject Matter Experts (SMEs) to ensure the documentation conforms to MRL standards for classification within a prescribed documentation hierarchy and adequately reflects the intended processes to support GRACS business activities.
Salary Range: $130,000 -$150,000 year
BACHELOR OF COMPUTER SCIENCE