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CSL Behring Regulatory Affairs Systems Scientist, docNet Administrator in Bern, Switzerland

Regulatory Affairs Systems Scientist, docNet AdministratorSwitzerlandR-0930101095 CSL Behring AG (CH)

Job Description

CSL Behring is a global biotherapeutics leader driven by its promise to save lives. In Bern more than 1500 employees develop and deliver life-saving therapies to treat people with rare and serious medical conditions worldwide.

For our location in Bern (Switzerland) or Marburg (Germany), we are looking for a

Regulatory Affairs Systems Scientist

As part of the GRA Systems & Data Management team, the Regulatory Affairs, Systems Scientist is responsible for effectively collecting, arranging, and sharing information to support business processes. This position executesday-to-day operations with focus on CSL Behring’s electronic Document Management System (docNet) in scope of Global Regulatory Affairs.

Main Responsibilities and Accountabilities:

1. Master Data Management

Maintains, facilitates and provides input as business administrator for management of master data and Global Regulatory Affairs (GRA) templates in scope of GRA docNet.This includes but is not limited to:

  • Defines and supports the business processes for set-up and maintenance of master data and templates in scope of Global Regulatory Affairs.

  • Implements governance, standards and definitions for master data and templates in scope of Global Regulatory Affairs in alignment with regulatory and business requirements.

  • Contributes to R&D Data Governance Working Group representing Global Regulatory Affairs.

  • Liaise with Global Regulatory Affairs business to identify requirements and translate those into efficient solutions.

  • Conducts research on regulatory data management requirements to stay up-to data on compliance standards.

  • Administers master data and templates owned by Global Regulatory Affairs as business Administrator.

2. Training and Support

  • Organizes and provides training (hands-on, in-person or on-line) to end users across the enterprise to support effective to facilitate user adoption in their daily work routine.

  • Contributes to creation and maintenance of guidance, training materials or new/improved functionality, and promotes GRA docNet.

  • Provides recommendations/guidance related to functionality, features, design, master data and templates.

  • Supports as super user business Global Regulatory Affairs in their daily work for content management and access.

  • Point of contact for questions or detected issues related to GRA docNet functionality and processes.

  • Documents and resolves recurrent issues. Escalate to HEAT system when appropriate.

3. Documentation & Compliance

  • Supports creation and maintenance of documentation for implemented solutions such as user requirements, process flows, etc.

  • Creates and updates SOPs / work instructions and training materials in scope of GRA docNet.

  • Contributes to creation and maintenance of policies and standards in scope of R&D docNet.

  • Uses testing, change management, and quality assurance practices to ensure the overall quality and Usability.

  • Cooperates with CSL Behring’s IT department regarding IT validation activities.

4. Metrics and Performance

  • Creates and maintain usage/accessibility/satisfaction Reports.

  • Works with users to eliminate problems and to improve the end user experience.

5. Project Management and Communication

  • Lead projects in scope of GRA IT systems or contribute to cross-functional Projects.

Qualifications & Experience:

  • University/College degree (BSc, MSc, Diploma) in an IT, technical or life science discipline or similar education Associate's Degree or equivalent work experience.

  • At least 5 years of experience in the Life Science Industry or IT, preferably in Regulatory Operations or Reglatory Affairs.

  • One to three-year experience of proven profound working experience withelectronic Document Management Systems (administering content, meta data and template management), preferablyOpenText D2, Life Science Suite.

  • Proven ability to effectively collect, structure, and share information to support business processes.

  • Analytical skills to discover business needs and design quick and effective solutions.

  • Understanding of GMP compliance, quality control procedures and documentation practices.

  • Experience in self-directing projects from conception through completion within established deadlines.

  • Excellent oral, written and interpersonal communication skills (German and English).

  • Ability to work independently and as a team member in global and cross-functional teams.

  • Innovative (thinking out-of-the-box), result-oriented, sharing Vision.

  • Willingness to accept and adapt to change to continue to learn and grow within the organization.

We are looking forward to receiving your online application. Applications must include a motivation letter and CV, as well as letters of references and copies of relevant transcripts and/or diplomas in the original language. Please include all these in one document together with the CV.

CSL Behring is committed to provide equal employment opportunity for all.

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State/Province : Berne

City : Bern

Street Address : Wankdorfstrasse 10

Primary Location : CSL Behring Bern

Additional Location(s) : CSL Behring Marburg

Full Time/Part Time : Full Time

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please click below.

CSL makes all employment decisions without regard to race, color, religion, national origin, ancestry, age, sex, gender, pregnancy, disability, marital status, sexual orientation, gender identity, genetic information, military status, protected veteran status (specifically status as a disabled veteran, recently separated veteran, armed forces service medal veteran, or active duty wartime or campaign badge veteran) or other classification protected by applicable US federal, state or local law. CSL complies with all applicable employment laws, including but not limited to Title VII of the Civil Rights Act of 1964, the Americans with Disabilities Act, the Fair Labor Standards Act, and the Immigration Reform and Control Act. https://www.cslbehring.com/careers/eeo-statement

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