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Clinical Evaluation Reporting Specialist

Date: Aug 8, 2019

Location: Lakewood, CO, US

Company: Terumo BCT, Inc.

Requisition ID:  23656  

 

The Clinical Evaluation Reporting Specialist is responsible for writing Clinical Evaluation Reports (CERs) for Terumo BCT 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 CERs.  A number of personnel from different departments will contribute documentation necessary for completion of a CER.  The Specialist brings these individuals together and directs them regarding the information needed for CERs.  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 Systematic Literature Reviews (SLRs), CER assessments, new CERs and scheduled CER updates. 

 

ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Lead the development of CERs by bringing together various stakeholders (eg, Clinical Safety, Quality Assurance, Regulatory Affairs, Clinical Affairs, Clinical Research Scientists, Pre-clinical Research Scientists, Marketing, Product Lifecycle Engineers, and information specialists [eg Terumo BCT librarians]) 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 Terumo BCT products and product families, and identifiedequivalent,comparator and competitor products
  • Review and Appraise the published literature to identify articles applicable to the safety and performance of Terumo BCT products.
  • Cross-lane collaboration to 1) understand regulatory submissions and priorities, 2) develop literature search stragety with design teams 3) Facilitate the SLR and produce the SLR report 4) compile necessary CER inputs (eg FMEA, RMR, HHA, PMSR, PRR, verfication reports, validation reports) 2) compile and analyze product complaints for both equipment and disposables, 3) conduct Adverse Event Reporting and Recall searches on Terumo products and product families and identified equivalent and comparator products, and 4) compile  preclinical data, including verification summary report and validation summary report 5) complie clinical data, including Clinical Investigation Protocols and Clinical Study Reports, for Clinical Investigations
  • Author the first draft of SLRs, CER assessments, new CERs and scheduled CER updates for Terumo BCT products, according to business and research priorities
  • Manage SLR and CER document reviews, reconcile major review comments and concerns, and manage finalization and approval of the CER
  • Collaborate with Clinical Research Scientist and Lead Pre-clinical Scientist on relevant cross-functional teams to provide input on risk management deliverables, clinical research and literature evidence for product development process needs

 

OTHER DUTIES AND RESPONSIBILITIES

  • Remain current in Clinical Evaluation Report regulatory requirements for all applicable countries
  • Develop policies/procedures related to Clinical Evaluation Reviews and Reporting, as needed
  • Assist with training contractor(s) on Clinical Evaluation Report development, as needed
  • Work with contractor(s) to guide development and update of Clinical Evaluation Reports, as needed
  • Dissemate findings quantified in the update process of Clinical Evaluation Reports
  • Develops Systematic LIterative Review logistics such as deliverables, timelines and draft reviews
  • Develops Clinical Evaluation Report 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

 

MINIMUM QUALIFICATION REQUIREMENTS

Education

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

 

Experience

  • Qualified individuals have 5 yrs experience  and should possess knowledge of the following: research methodology; information management; experience with relevant databases such as PubMed; regulatory requirements; medical writing; 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
  • The CER Specialist has experience and understanding of clinical research and regulatory guidelines

Skills

  • Possess leadership skills
  • Possess interpersonal savvy and ability to develop and maintain crucial interdepartmental relationships
  • Work effectively alone and with minimal direction or supervision as well as function effectively as a part of a multi-disciplinary team
  • Effectively prioritize and progress multiple simultaneous priority projects and demands
  • Able to present concepts and information to a wide variety of disciplines and functions related to CER content
  • Develop and implement global policies and procedures
  • Analyze information coming from multiple internal an external sources
  • Solid understanding of scientific/clinical research methodology
  • In-depth knowledge of regulatory process (CE Marking, IDE, PMA, 510(k), post-market/post approval), GCP procedures, and legal compliance for pharmaceutical and/or medical device industry
  • Dremonstrated ability to utilize a variety of software programs (e.g., Microsoft Office, Excel, Word, PowerPoint, Access)
  • Demonstrated writing capability and critique of clinical and regulatory documentation
  • Program/project management skills for effective project execution and management
  • Facility with general writing and presentation software

 

 

PHYSICAL REQUIREMENTS

Typical Office Environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds.

The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties

 

We are proud to be an Equal Opportunity Affirmative Action Employer.  All applicants will be afforded equal opportunity without discrimination because of race, color, religion, sex, gender identity or expression, sexual orientation, marital status, order of protection status, national origin or ancestry, citizenship status, age, physical or mental disability unrelated to ability, military status or an unfavorable discharge from military service.

 

Terumo BCT is committed to providing a safe and secure working environment.  We maintain a drug-free workplace and perform pre-employment substance abuse testing and detailed background verification checks.  To this end, all employment offers for positions in the U.S. are conditional upon successful completion of Terumo BCT's pre-employment screening process.  As of January 1, 2017 the Terumo BCT Lakewood, Colorado location will be a tobacco-free workplace. For more information about Terumo BCT, visit our website www.terumobct.com/careers.


Join Terumo BCT as we unlock the potential of blood. We are a global leader in blood component and cellular technologies, and the only company with the unique combination of apheresis collections, manual and automated whole blood processing, and pathogen reduction coupled with leading technologies in therapeutic apheresis and cell processing. We believe in the potential of blood to do even more for patients than it does today. This belief inspires our innovation and strengthens our collaboration with customers.

 

As the largest medical device manufacturing company headquartered in Colorado, we are home to more than 2,300 associates and our products are in use in more than 125 countries and territories. Our Global footprint includes more than 5,500 associates and partners with regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo.

 

Our company has almost $1B in annual revenues and has been voted and recognized as:

  • Largest corporate sponsor in Rocky Mountain Region for Leukemia and Lymphoma Society (LLS)
  • Winner of the Association for Talent Development (ATD) BEST Award for providing exceptional employee learning and talent development (2011 & 2012)
  • One of Colorado’s Healthiest Employers by Denver Business Journal (2014 & 2015)
  • Recipient of the Way to Go Employer award through the Denver Regional Council of Governments (DRCOG) 2015

 

Our award-winning culture embraces:

  • Leading technology through innovation and R&D
  • Wellness programs
  • Commitment to quality
  • An environment that values, respects and rewards your individual contributions
  • A philosophy of intentional growth and responsiveness to world health issues

 

Click Here to see what our associates have to say about our culture.

 

Each associate has a positive impact on our future by:

  • Connecting to the lives of the patients we ultimately serve
  • Growing through professional and leadership development activities
  • Sharing company success through incentive plans

 

If you are the best at what you do and want to do work that is changing the delivery of healthcare globally, we invite you to work with us now to see how we can unlock your potential.


Nearest Major Market: Denver

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