Merck

This role represents the CP Expert Team to the global cross functional drug discovery and development project teams, in close collaboration with colleagues in Biostatistics, Data Sciences, Clinical Biomarkers and Diagnostics, Research, Clinical Development and other colleagues within the R&D organization.

Higher degree in a scientific discipline e.g. computer science, engineering, natural sciences, pharmacy; Merck

Graduate or post graduate degree in BPharm/MPharm, PHD, BDS Dental, BSC/MSC or equivalent job experience with comprehensive Medical Writing knowledge of theories, principles and concepts

The Senior Specialist, Expert License Management prepare dossiers and execute actions that support the license security and product compliance on the markets, and that meet companys and health authorities requirements. Encounter the challenges to enable representatives from all major disciplines involved to reach agreement on the license management strategy and approach.

Regulatory Affairs Manager prepare dossiers and execute actions that support the license security and product compliance on the markets, and that meet company's and health authorities’ requirements. Encounter the challenges to enable representatives from all major disciplines involved to reach agreement on the licence management strategy and approach.

As a Principal Medical Writer you will play a pivotal role in leading the Medical Writing efforts for Marketed Products and Lifecycle Management, both globally and at regional, local levels. You will represent the department as a subject-matter expert on clinical study teams, leading document-related meetings and reviewing study-related documents.

As a Senior Specialist, Expert Medical writer , you will support the Medical Writing efforts for Marketed Products and Lifecycle Management, both globally and at regional/local levels. Independently prepares of clinical and regulatory documents such as Protocols, Clinical Study Reports, or Investigator Brochures.

The position will be working in a matrix organization with extensive communication and collaboration with stakeholders from various functions within or outside Global Regulatory Affairs. The role will have to enable the preparedness of the employees to work on different projects and roles, to facilitate communication within the matrix organization, to ensure efficient and scalable resourcing supporting the business priorities.

The Specialist, Regulatory Affairs Manager prepare dossiers and execute actions that support the license security and product compliance on the markets, and that meet companys and health authorities’ requirements.