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Scientific Data Management Expert

#PolpharmaBiologics is a state-of-the-art biological R&D and manufacturing facility, one of the most modern in Europe. We have a fantastic, international team of experienced experts and dynamic young scientists with common goals and values. Biotechnology is our passion. Together we develop medicine, offering new hope to patients suffering from serious diseases.

We create a passionate and friendly workplace environment. Join us!

 

 

WE ARE LOOKING FOR:
Scientific Data Management Expert
Duchnice (pow. warszawski zachodni)
WHAT MAKES US SPECIAL
  • International work environment
  • Attractive salary
  • Cutting-edge technology equipment
  • Conferences and trainings around the world
You will take care of:
  • Establishing and coordinating the data management operational
    activities in order to achieve high quality databases, in a timely manner, to support processes from drug substance and drug product development up to manufacturing as well as supporting strategic vendor relationships
  • As a member of the Manufacturing Science and Technology Department Team, coordinating and managing opportunities for process optimization, interfacing with other departments and functions and coordinate user requirements for SDM technologies
  • Contributing to implement ongoing improvements within Data Management to ensure data integrity and data quality requirements of process development and manufacturing
  • Developing, reviewing and implementing Data Management processes, policies and SOPs
  • Developing Data Management metrics and key performance indicators
  • Identifing opportunities and implementing solutions to globalize and standardize methods, processes, procedures, systems and templates in accordance with regulatory authorities requirements and industry best practices
  • Overseing planning, execution and maintenance of major projects, if required
  • Supporting study-level/program audit and inspection readiness activities as needed.
  • Leading data management support of submission activities
  • Maintaining proficiency in Data Management systems and processes through regular training and/or attendance at professional meetings/conferences
  • Ensuring the delivery of quality data by partnering with other departments across Polpharma Biologics Group members and external clients
  • Training and mentoring the identified representatives in the different departments and functions to carry out and sustain SDM, projects, systems and programs
  • Performing hands-on data management responsibilities
If you have:
  • MSc degree, a scientific or engineering discipline
  • 5+ years experience with data management tools, with experience building data management functions and developing initiatives designed to promote efficiency and productivity
  • Advanced hands-on knowledge of data management processes and systems/software
  • Experience in biopharma industry and knowledge of regulatory requirements (e.g. ICH, EMA, FDA) will be an asset
  • Strong project management skills, and ability to effectively lead and collaborate with various business functions
  • Ability of working on multiple projects simultaneously, independently managing competing priorities, and define tracking tools to manage projects
  • Excellent written and verbal communication skills, able to communicate effectively with senior management as well as with peers.
  • Understanding of biological drug development and manufacturing processes
  • Experience with data visualization, analytics and reporting tools
  • Fluent English
Join our Team!
We offer
  • Sport Card
  • Development programs
  • Private healtcare
  • Relocation package
  • Fruit day
  • Integrations events
  • Benefit platform
  • and more
Apply for the job
Contact us for details
Recruiter
Aleksandra Bufnal
aleksandra.bufnal@PolpharmaBiologics.com
Visit us
www.polpharmabiologics.com

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