Merck Group - Lead Expert - GREX-0 - Regulatory Information Management

GREX-0, Lead Expert

Your Role:

Accountability:

- Lead and execute the operational strategy for IDMP

- Lead to IDMP data management activities - like O and R data management

- Contributes to training and documentation creation as per data entry guidances and systems functionalities

- Partners with Global Regulatory Affairs and other functions, departments and divisions for process and data quality topics as well as IDMP related topics

- Accountable for operational deliverable Quality and give time to operational strategy input.

- Participates in data cleansing activities related to data quality initiatives, data migrations or xEVMPD

- Provides support, training and end user communication for data management topics

- Contributes to migration and data verification topics

- Ensures compliance to health authority requirements on data submissions

- Provide support for IDMP intelligence and detailed impact assessment based on new published IDMP guidelines on EMA SPOR, ICH Guidelines and other related programs e.g. Serialization/FMD, ICH E2B (R3), as applicable.

- Provide support on impact assessment of new regulatory guidelines, not directly related to IDMP but with impact on IDMP related processes and documents.

- Drive Text Mining related activities for integration of systems and support the TM Data Quality Program with his/her expertise on IDMP

- Extensive support in PMS readiness with the new RIM system and Data Quality program for IDMP readiness

Impact:

- Supports implementation of data governance for Global Regulatory Affairs and beyond

- Ensures adherence to data quality principles for regulatory data

- Contributes to define the strategy of the Regulatory Compliance & Regulatory Information Management Department

- Liaise with Health Authorities on data submission topics (e.g. xEVMPD)

Who you are:

Education:

- Basic degree in a scientific discipline or related work experience in the chemical-pharmaceutical industry

- Regulatory information management and pharma IT background

- Good knowledge of current regulatory data standards

- Fluent command of spoken and written English

Work Experience:

- At least 12 years of professional experience from a pharmaceutical, service provider or IT industry setting, thereof of least 10 years in Regulatory Affairs

- Experience in Regulatory information management

- Demonstrated practical working experience in both processes (e.g. xEVMPD) and utilisation of regulatory systems (RIMS, DMS, SAP)

Job specific Competencies & Skills:

- Extensive IDMP knowledge

- Good understanding of Regulatory Affairs business processes

- Regulatory Information management experience

- Good understanding of both processes (e.g. xEVMPD) and systems (e.g. RIMS, DMS, SAP)

- Results-driven and pragmatic approach to work

- Good organizational skills, self-motivated and proactive

- Meticulous working style and high attitude to quality

- Good stakeholder management and communication skills

- Strong service mentality

- Quick comprehension, good analytical and problem-solving skills

- Ability to work in a virtual and matrix environment