Pharmaceutical Scientist - Global Regulatory Operations (m/f/d)
Location
Mainz | Germany
Job description
Become a member of the BioNTech Family!
As a part of our team of more than 5.000 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards - writing medical history.
We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.
Associate Director Global Regulatory Affairs - Regulatory Operations (RIMS)
As part of the Regulatory Information Management (RIM) team you will (co-) lead respective topics and conduct data focused regulatory operations activities and projects required for maintenance and readiness of data and systems. Conduct regulatory operations driven data governance in RIM system and align master data across systems. Serve as Regulatory expert for IDMP and other data standards topics and define processes for data flow and management across systems and functions. Support system- and process implementations cross-functionally with focus on data management
Aufgaben:
- Leading conceptual design of processes and establishing process architecture with focus on systems and data management for/in Global Regulatory Affairs (GRA)
- Define and support Regulatory Operations tasks focusing on RIM(S) and data maintenance in collaboration and alignment with GRA and cross-functional stakeholders and initiatives. As Regulatory IDMP expert you maintain the overview of current and future IDMP and other data standards and implement these as applicable in BNT processes and systems in alignment with cross-functional IDMP responsibles
- Define and execute processes for governance of RIM records in RIMS, and in alignment with Master Data Management (MDM) initiatives, tools and systems. Support MDM quality control and enrichment. Manage the data model overview and maintenance of controlled vocabulary in RIMS
- Define and execute management and maintenance of data submissions and processes, i.e. SPOR, IRIS, IDMP, xEVMPD. Define and improve processes in alignment with authority requirements and business stakeholders within and outside of GRA for high quality data maintenance in and across systems and high-quality data exchange as required by authorities
- Apply defined processes accordingly to the defined roles incl. systems. Further, support continuous efforts to improve and adjust processes and systems accordingly to the need from BioNTech´s GRA Regulatory Operations
Qualifikationsprofil:
- Degree in pharmacy, chemistry, biology, biochemistry, or medicine
- Minimum 5 years professional working experience in a relevant field in the pharmaceutical industry
- Experience in introducing and maintaining software solutions in global cross-functional settings
- Experience in working in Regulatory Information Management, with data standards and master data management in Regulatory Operations
- Proficiency in Microsoft Office, Adobe Acrobat, Sharepoint, RIM systems
- Cross-functional and cross-cultural team player
- Results- and goal-oriented
- Excellent communication skills in English
- Experiences in Adonis and Generis Cara are a Plus
Benefits:
BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.
Click here to find out more about what we do, the careers we offer and also the benefits we provide.
Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.
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