Beschreibung
For our client we are looking for a Technical Writer (m/f/d) Pharma.Start: asap
Duration: till 31.12.2022 ++
Working location: Mannheim, remote
Background:
Within the Pharma Informatics Technical Operations and Services Network (PTIX O&S Network), you will collaborate and provide a list of Computerized System Validation (CSV) deliverables such as the Validation Plan, Validation Report, and other documentation.Aufgaben:
- Writes and updates Computerized System Validation (CSV) documentation in German for client systems, while respecting project requirements and documentation standards.
- Independently collects information required to produce the outputs.
- Cooperates closely with documentation project managers, service personnel, trainers, developers, and other subject matter experts.
- Organizes documentation reviews by subject matter experts, and implements their input.
- Ensures that quality targets, timelines, and regulatory requirements are respected.
- Is enthusiastic about technical writing and contributes to frequent discussions aimed at the continuous improvement of our processes and guidelines.
- Might manage localization projects (for software and documentation) in close collaboration with software development, translation agencies, and country organizations.
- Collaborate closely with the Validation Lead and Business Quality to assess change request(s) via a change management process by providing English to German translation.
- Proven experience in technical writing, preferably in a pharmaceuticals and/or diagnostics business environment
- Proven experience with Adobe Framemaker (XML-based) or a similar authoring tool
- Knowledge of multimedia tools and processes used in state-of-the-art technical documentation
- Excellent spoken and written command of German (native speaker or equivalent level), since most of the documentation will be in German and working with German-speaking teams.
- Ability to communicate in an international environment with subject matter experts from different functional areas.
- English understanding (spoken and written), since part of the team, is also English speaking.
- Familiarity with laboratory systems and manufacturing systems and corresponding environments.
Nice to Haves:
- Experience with Electronic Document Management System and Quality Management System (e.g. Veeva, TrackWise, ValGenesis, ServiceNow)
- Experience in minimalistic and topic-oriented writing.
- Familiarity with hardware and software development processes