at Terumo BCT
Posted on Sep. 3, 2016
CLINICAL EVALUATION REPORTING SPECIALIST
The Clinical Evaluation Reporting Specialist is responsible for writing Clinical Evaluation Reports (CERs) for Terumo BCT products. The Specialist relies on clinical data, published literature, complaints, 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 the final compilation/authoring of new CERs and annual CER updates.
ESSENTIAL DUTIES AND RESPONSIBILITIES
* Lead the development of CERs by bringing together various stakeholders (eg, Quality Assurance, Regulatory Affairs, Clinical Affairs, Clinical Research Scientists, Pre-clinical Research Scientists, and literature search representatives [eg Terumo BCT librarians]) to identify relevant documentation needed for the content of CERs.
* Collaborate with the literature search representatives to conduct literature searches on Terumo BCT products and product families, and identified predicate and competitor products
* Review 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) compile product complaints for both equipment and disposables, 3) conduct Adverse Event Reporting searches on Terumo products and product families and identified predicate and competitor products, and 4) compile clinical data, including Clinical Investigation Protocols and Clinical Study Reports, for Clinical Investigations
* Author the first draft of new CERs and annual CER updates for Terumo BCT products, according to business and research priorities
* Manage CERs 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
* 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 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
Bachelor's degree in biological or medical science is required or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered
* PhD in a scientific discipline preferred.
* Minimum 2 years technical writing or clinical evaluation reporting experience in academic or the medical device/pharmaceutical industry in clinical or regulatory roles
* The Specialist has experience and understanding of clinical research and regulatory guidelines
* 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
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, 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.
We maintain a drug-free workplace and perform pre-employment substance abuse testing and background verification checks. As of January 1, 2017 the Terumo BCT Lakewood, Colorado location will be a tobacco-free workplace.