Specialist, R&D Data and Documentation – Minneapolis-Saint Paul, MN

Rebiotix Inc, part of the Ferring Pharmaceuticals Group, is a late-stage clinical microbiome company focused on harnessing the power of the human microbiome to revolutionize the treatment of debilitating diseases. Located in Roseville, Minnesota, our goal is to improve the lives of patients and reduce the cost of care associated with complex diseases through our innovative microbiota-based MRT™ drug platform. We are a passionate team of scientists, engineers, and clinical researchers motivated by the opportunity to blaze new trails and create new technologies for today’s medical needs. We are looking for like-minded get-it-done individuals to add to our growing team.

Our drive to find patient solutions amplifies the core value of our parent company, Ferring Pharmaceuticals, through the Ferring Philosophy: People Come First at Ferring. This philosophy has inspired Ferring’s approach to relationships with patients, physicians, employees and other stakeholders. Ferring is a globally recognized research-driven biopharmaceutical company with more than 65 years of innovation in the medical arena. Headquartered in Switzerland, Ferring is a privately-owned company with locations in over 60 countries with a global employee base of approximately 6,500 employees in the fields of reproductive health, urology, gastroenterology, endocrinology, orthopedics and oncology. We are the largest and most clinically advanced microbiome company worldwide.

Summary:

The role will focus on development and execution of R&D data management systems, documents and processes to ensure data integrity and document compliance

Responsibilities:

Author, review, and/or contribute to quality- and manufacturing-related documents generated by the R&D team, including:

  • Batch records
  • Deviations
  • Change controls
  • Establish data review and integrity assurance processes for R&D
  • Serve as primary liaison from R&D to Quality Control/Assurance groups to ensure clear, diplomatic, and deliverable-focused communications
  • Serve as reviewer and editor of R&D experimental procedures and reports.
  • Primary owner of R&D equipment and laboratory documentation, ensuring up-to-date calibration, maintenance scheduling.
  • Refine best practices for ensuring R&D data integrity

Requirements:

  • BA or BS degree in life sciences, bioengineering, or equivalent areas preferred or equivalent related work experience
  • Minimum 2 years industry experience in a regulated setting, managing data and documentation

Skills:

  • Knowledge of FDA data integrity guidance, ideally with experience implementing guidance
  • Highly proficient in MS Excel and Word
  • Excellent and diplomatic oral and written communication skills
  • Familiarity with data processing, analysis, reporting conventions

We are proud to be an Affirmative Action/EEO Employer. EOE Minorities/Females/Protected Veterans/Disabled

We maintain a drug-free workplace and perform pre-employment substance abuse testing.

Job Type: Full-time

Experience:

  • regulated industry: 2 years (Required)

Education:

Additional Compensation:

Work Location:

Benefits:

  • Health insurance
  • Dental insurance
  • Vision insurance
  • Retirement plan
  • Paid time off
  • Parental leave
  • Professional development assistance
  • Tuition reimbursement

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