Merck KGaA

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Originele vacaturetekst

Associate Director, Regulatory Compliance and Regulatory Information Manager (all genders)

A career at our company is an ongoing journey of discovery: our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

Your Role:

We are looking for a self-driven, detail-oriented and enthusiastic individual to take on an exciting challenge in Regulatory Affairs. As an expert for Regulatory Compliance and Regulatory Information Management you will ensure efficient processes, manage and guide personnel and oversee data management operations to ensure quality and timely delivery of high-quality regulatory data. You will drive the regulatory transformation to the next level considering advanced technologies like advanced analytics, process mining, automation and artificial intelligence. Further aspects of the role include:

  • Contribution as Subject Matter Expert with dedicated business process know how for Regulatory Compliance and Regulatory Information Management and Standards to our cross-functional projects and strategic initiatives like IDMP as well as the implementation of Veeva Vault RIM for IDMP
  • 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)
  • Develop reporting and analytics strategy and implement the concept, considering data principles (e.g. FAIR)
  • 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 Merck processes
  • Fostering of a data driven mindset within GRA
  • 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 Operations
  • Support user community to analyze system data and provide recommendations for these analysis

Who you are:

This position requires an advanced university degree in a scientific discipline combined with sound background in regulatory, data management and IT affinity

  • At least 8 years of experience from a pharmaceutical industry or service provider with strong business focus within EEA
  • At least 5 years in Regulatory Affairs with a knack for data/information management
  • Good understanding of Regulatory Affairs business processes and experience in delivering improvements/ changes to business processes
  • Excellent data management experience including data governance and master data management
  • Practical knowledge of data management principles ALCOA+ and FAIR
  • 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 RIM is a plus
  • Fluent English
  • Strategic, innovative, and lateral thinking along with a pragmatic approach to work
  • Strong in conceptional work with ability to implement practically
  • Strong customer orientation and excellent stakeholder management and communication skills and being an pro-active change driver
  • Work independently, Results-oriented, entrepreneurial and self-motivated
  • Goal-oriented, pragmatic, meticulous working style, high attitude to quality
  • Agile mindset and change oriented
  • Work experience in multi-cultural/ multi-national organizations is highly desired, and cultural awareness a given

What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at https://jobs.vibrantm.com

Art des Stellenangebotes:
Intern

Fähigkeiten

  • Es ist kein Abschluss erforderlich