Medical Writer

For one of our global successful customers we are looking for a:

Manager Content Management & Support (m/f/d)

We are looking for a new colleague to strengthen the team at the headquarter in Germany, while you will be located in Wroclaw, Poland, a so called satellite office together with other colleges.

You can expect exciting, versatile, and challenging tasks in an international and dynamic environment including tasks and projects within your own responsibility and you will work in close collaboration with the German team. Take on responsibility and become a member of a highly dynamic team in a truly global environment that actively contributes value to our community.

Sounds like you?

Your assignments

Support business operations of the Dossier Publishing and Validation System (eCTDManager) and the Submission Document Management System (SDMS) including:

• Processing of user requests, provision of system function instructions and responsibilities, and provision of supporting information for both systems
• Planning and implementation of changes within the framework of the change management process as well as definition and implementation of necessary test activities (e.g. regression test, tests for error case analysis, etc.) in close coordination with the Process Owner, System Owner, Validation Owner
• Supporting the implementation of configuration changes and further developments of the system including the necessary documentation and PQ testing
• Planning and conducting of system periodic reviews as well as coordination of the creation of SOPs and WIs
• Acting as the primary point of contact for business requests for system interfaces (inbound / outbound) and leading the communication with the Process Owners of the relevant third party systems
• Assistance in the delivery of national and international trainings including the tracking of the relevant GxP documentation

Your profile

• A Degree in pharmacy, natural sciences or engineering or commercial training, preferably in the pharmaceutical field with min. 3 years of professional experience
• 2 years of professional experience in drug regulatory affairs in both regulated and non-regulated settings, electronic document management and e-publishing
• Very good experience in drug regulatory affairs, dossier publishing solutions such as extedo eCTDManager and/or Lorenz docuBridge
• Very knowledgeable in the use of government validation tools for eCTDs and other formats and interpretation of validation reports
• Knowledge of and experience with project management tools (e.g. PMI, PMBOK, IPMA, Agile)
• Qualification and experience in compliance (GxP, EU GMP Annex 11, 21 CFR Part 11, ISO, GAMP5, Business Process Flow Diagrams) and data management (Enterprise Content Management, Database/SQL, Data Integrity)
• Very good command of written and spoken English

Sounds like your challenge or you?

Speak with Robert Reiter for more details +49 69 348 757 660 or by mail rr@externe-hr.de

All what we need is your CV. Let's talk.

Our job advertisements are always directed at all people capable of working, regardless of age, gender, origin, sexual orientation, disability, religion and ideology, etc. Applicants are exclusively selected based on their qualifications. Errors in the given information and spelling reserved.