Regulatory Compliance Information Specialist @ MERCK

Regulatory Compliance Information Specialist @ MERCK

Your Role:

Contribution as Subject Matter Expert with dedicated business process know how for Regulatory Information Management and Standards to our cross-functional projects and strategic initiatives like IDMP as well as the implementation of Veeva Vault

Ensure data governance rules (master/meta data dictionaries, processes and data flow across multiple applications) are implemented and followed to achieve as well as maintain global data consistency of IDMP related applications and systems (RIMS, xEVMPD, IDMP):

Define data quality measures for data entry and data maintenance processes and manage evaluation of data quality

Define and implement reports and controls to verify and monitor regulatory data quality

Conduct and support data quality activities like data migration, data verification, data completion, or data clean-up/correction incl. xEVMPD/IDMP maintenance

Monitor and report on compliance with defined data quality standards

Ensure that the future – merged of Regulatory Data (e.g. xEVMPD, IDMP, ePI) and dossier submission processes (eCTD, eAF, CESSP, EU-CTR) are properly taken into account in organization processes.

Consolidate corrective action plans to improve regulatory data quality

Partner with GRA and other functions, departments and divisions for regulatory data management related topics

Provide support, documentation, training and end user communication for regulatory data management related topics

Provide data management methodology knowhow to support the processes in GRA OPS

Support user community to analyze system data and provide recommendations for these analysis

Export and extract system data and provide ad hoc reports as required

Who you are:

At least 5 years of experience from a pharmaceutical industry or service provider with strong business focus

At least 3 years in Regulatory Affairs with a knack for data management

Excellent data management experience including data governance and master data management

In-depth expertise on both regulatory processes for submission of data and documents for medicinal products (e.g. xEVMPD, IDMP, IND, CTA, MAA, lifecycle management) and utilisation of regulatory systems (RIMS, DMS, SAP)

Experience in Veeva Vault is a plus

Fluent English

Work independently, self-motivated

Goal-oriented, pragmatic, meticulous working style, high attitude to quality

Agile mindset and change oriented

Strong service mentality

Excellent communication skills

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