Biontech Ag - Cambridge, MA

posted 5 months ago

Full-time - Mid Level
Cambridge, MA
1,001-5,000 employees
Professional, Scientific, and Technical Services

About the position

As a Manager in CTSM Patient Operations Logistics at BioNTech, you will play a pivotal role in overseeing the operations specialists responsible for patient care within clinical trials. Your primary responsibilities will include hiring, training, and evaluating the performance of the operations team to ensure they meet the highest standards of patient care. You will establish and refine processes and author procedures that support the end-to-end patient care journey, ensuring that all operations align with regulatory requirements and internal policies. This role requires you to author, review, and update essential documents such as Standard Operating Procedures (SOPs) and templates, ensuring that all documentation is current and compliant with industry standards. In addition to operational oversight, you will monitor trends and identify improvement opportunities within the Patient Operations team. You will represent Clinical Trial Supply Management (WP08) in both internal and external project and trial teams, acting as a liaison to ensure that all aspects of patient operations are effectively communicated and executed. Your adherence to regulatory requirements and procedures will be critical in maintaining the integrity of the clinical trial process and ensuring the safety and well-being of trial participants.

Responsibilities

  • Oversee hiring, training, and performance of operations specialists
  • Establish processes and author procedures to support and oversee end-to-end patient care
  • Author, review and update related documents (SOPs, Templates, etc.)
  • Monitor trends and improvement opportunities for Patient Operations team
  • Represent Clinical Trial Supply Management (WP08) in internal and external project and trial teams
  • Ensure adherence to regulatory requirements and respective procedures (policies, SOPs, instructions)

Requirements

  • Degree in pharmacy, chemistry, biotechnology, biochemistry or related discipline or engineer with profound understanding of natural scientific processes
  • Relevant professional experience (usually +3 years) in Pharmaceutical or Biotech or any other equivalent industry setting
  • Project Management Experience
  • Demonstrated quality management experience
  • Effective stakeholder management in cross-functional internal and external matrix team environment
  • Experience in cold chain logistics and handling of temperature deviations
  • Proven track record in writing regulatory documents like SOPs
  • Documented experience in deviation/change/CAPA handling
  • Business-professional English language skills
  • Profound skills in the application of standard software (e.g. MS Office)
  • Excellent organizational and communicative skills
  • Ability to coach, mentor, and collaborate with business partners, analysts, and team members

Benefits

  • Competitive remuneration packages
  • Variety of benefits in support of diverse employee base
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