[Hiring] Global Clinical Regulatory Support Specialist @Terumo BCT, Inc.

Role Description

The Global Clinical Regulatory Specialist is responsible for writing Clinical Evaluation Plans & Reports (CEPs, CERs) and Post-market clinical follow up (PMCF) Plans & Reports for Terumo Blood and Cell Technologies (TBCT) products. The Specialist relies on product labeling, preclinical data, clinical data, published literature, risk management documentation, complaints, post market surveillance, and adverse event reporting to create the documentation. The Specialist will be responsible for data collection, data appraisal, data extraction from the available safety and performance data set. The Specialist will be responsible for the final compilation/authoring of new and scheduled Systematic Literature Reviews (SLRs), Clinical Evaluation and PMCF documentation for a variety of devices.

• Lead the development of CERs and PMCF by bringing together various stakeholders (e.g. Clinical Safety, Quality Assurance, Regulatory Affairs, Clinical Affairs, Clinical Research Scientists, Pre-clinical Research Scientists, Marketing, Product Lifecycle Engineers, and information specialists) to identify relevant documentation needed for the SLR and to import into the content of CERs.
• Collaborate with the information specialist to conduct systematic literature searches on TBCT products and product families, and identified equivalent, comparator and competitor products.
• Review and Appraise the published literature to identify articles applicable to the safety and performance of TBCT products.
• Cross-lane collaboration to:
  • Understand regulatory submissions and priorities.
  • Develop literature search strategy.
  • Facilitate the SLR and produce the SLR report.
  • Compile necessary inputs (e.g. risk management, labeling, postmarket surveillance, verification reports, validation reports).
  • Compile preclinical data, including verification summary report and validation summary report.
  • Compile clinical data, including Clinical Investigation Protocols and Clinical Study Reports, for Clinical Investigations.
• Author new and scheduled SLRs, CER and PMCF documents for TBCT products, according to business and research priorities.
• Manage document reviews, reconcile major review comments and concerns, and manage finalization and approval of the SLR, Clinical Evaluation and PMCF documents.
• Collaborate with relevant cross-functional teams to provide input on risk management deliverables, clinical research and literature evidence for product development process needs.
• Manage ongoing proactive literature review to identify complaints or safety concerns for a specific product portfolio.
• Represent functional group for audits and contribute to global regulatory body submissions or responses.
• Remain current in Clinical Evaluation and PMCF regulatory requirements for all applicable countries.
• Develop policies/procedures as needed.
• Work with contractor(s) to guide development and update of documents, as needed.
• Disseminate findings quantified in the update process of Clinical Evaluation and proactive literature reviews.
• Develop Systematic Literature Review, Clinical Evaluation and PMCF logistics such as deliverables, timelines and draft reviews.
• This position is required to assure compliance of Company operations to all applicable laws, regulations, and standards, good business practices and company documented procedures.

Qualifications

• A graduate degree (e.g. MS, PhD) in a scientific, biological or medical science discipline and/or regulatory discipline or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.

Requirements

• 5 years experience with knowledge of research methodology, information management, experience with relevant databases, regulatory requirements, training and experience in medical writing, systematic review, and clinical data appraisal.
• Clinical evaluation reporting experience in academic or the medical device/pharmaceutical industry in clinical, or regulatory roles, or device development experience in medical device/pharmaceutical industry.
• Experience and understanding of clinical research and regulatory guidelines.

Benefits

• Competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life and recognition programs.
• Multiple group medical, dental and vision plans.
• Robust wellness program.
• Life insurance and disability coverages.
• Variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more.
• 401(k) plan with a matching contribution.
• Vacation and sick time programs for associates.