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Manager, Clinical and Regulatory Affairs

Company: Kelly
Location: Newberg
Posted on: May 15, 2022

Job Description:

Kelly Science and Clinical is the world's most recognized brand in science and clinical staffing with more than 100 locations in North America, Europe, and the Pacific Rim. Our scientists contribute to the research and development of the next generation of small molecule drugs, biologics and cellular therapies. Overview Plans and directs clinical research program including study development, preparation, execution, oversight, oversight; plans and directs company regulatory matters including development, submission and maintenance of regulatory submissions, company registrations, regulatory responses pertaining to inquiries and inspections, and collaboratively with Quality Assurance, compliance with applicable regulations. Duties are performed personally, through subordinates or in collaboration with other departments. Coordinates project priorities within the Clinical Trials and Regulatory group and provides oversight of key clinical trial and regulatory decisions. Ensures that all Clinical trials and testing all Regulatory actions comply with Design Controls, Good Laboratory Practices and Good Manufacturing Practices (including FDA QSRs, ISO13485, etc.) as appropriate. Responsibilities

  • Manages clinical research and development aspects of the company's product development efforts and product improvement projects, in collaboration with the individual project manager within or outside the Regulatory/Clinical Affairs department.
  • Coordinates with R&D Project Manager regulatory submissions and regulatory approvals.
  • Maintains Clinical Research Files and conducts clinical studies under Good Clinical Practices (GCP) and Good Clinical Laboratory Practices (GCLP) according to applicable clinical regulations and guidance.
  • Takes actions needed to ensure Company's regulatory status with all applicable regulatory agencies and oversees response to any regulatory actions, coordinating Company response.
  • Routinely interacts with other internal and external management functions (e.g. Quality, Ops/Mfg., Sales & Marketing, Finance, Engineering, R&D, CRO's, CMO's, Clinical Sites, Consultants, Contractors and Vendors.) Ensure Regulatory compliance for project team activities and output consistent with expectations of Quality System. Ensures team follows GCPs and GCLPs and complies with applicable regulations as appropriate.
  • Responsible for the Regulatory and Clinical Affairs Department including organization development, direction, coordination and evaluation of activities within.
  • Carries out supervisory responsibilities in accordance with the department's policies and applicable laws.
  • Responsibilities include interviewing, hiring, and training employees, planning, assigning, and directing work, appraising performance, rewarding and disciplining employees and addressing complaints and resolving problems. Qualifications
    • B.S. with 10+ years, M.S. with 5+ years; Biochemistry/Immunology/Microbiology/Biology/Genetics/or similar.
    • 5+ years in medical device or pharma arena required, including experience in medical device clinical trial development, execution and report, and/or medical device regulatory submission development, submission, agency prosecution and ongoing support.
    • Experience in GCPs, GCLPs and GMPs. Experience as primary project manager for all clinical and regulatory aspects of one or more product developments and launches.
    • Prior experience managing experienced clinical technical personnel, including preferably on and offsite clinical research associates, trial managers, internal and external clinical trial managers. Prior experience managing junior associates for regulatory affairs highly desirable. You should know: Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process. Why Kelly - ? Kelly - Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed. About Kelly - At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world. Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. ]]

Keywords: Kelly, Portland , Manager, Clinical and Regulatory Affairs, Executive , Newberg, Oregon

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