What are the responsibilities and job description for the Clinical Affairs Specialist/ Medical Writer position at FISI - FUJIFILM Irvine Scientific?
Position Overview
We are hiring a Clinical Affairs Specialist. The Clinical Affairs Specialist will be responsible for assisting in the development and generation of Clinical Evaluation Plans and Reports (CEPs, CERs), conducting clinical literature searches, performing analysis of clinical literature, and evaluating and reviewing clinical data, generated both pre and post-market for medical devices and in vitro diagnostic devices. In addition, the Clinical Affairs Specialist will assist in performing annual activities associated with Post Market Surveillance (PMS) program, including but not limited to, preparing and writing plans, reports and Post Market Clinical Follow-Up (PMCF).
Company Overview
FUJIFILM Irvine Scientific, Inc. is a global leader in the innovation and manufacture of cell culture solutions for Life Science and Medical markets, providing products and services that assist customers in advancing healthcare initiatives. Working across discovery research, cell and gene therapy, reproductive medicine and cytogenetics, as well as the large-scale production of biotherapeutics and vaccines, the Company is trusted by researchers, manufacturers, and clinicians worldwide. For over 50 years, FUJIFILM Irvine Scientific’s Mission has been to empower all who bring medicines and treatments to life with unmatched quality and responsiveness in its products and custom solutions, providing customers with the vital resources needed to enrich human lives through innovative, accessible therapies. The Company’s facilities adhere to both ISO and FDA regulations, with manufacturing facilities that follow cGMP guidelines in the USA, Japan, and the Netherlands, and a media optimization center in China. All sites prioritize strategies that adhere to the FUJIFILM Sustainability Value Plan 2030 for sustainable growth. FUJIFILM Irvine Scientific, Inc. is a subsidiary of FUJIFILM Holdings America Corporation reporting to FUJIFILM Holdings Corporation.
Job Description
Responsibilities
- Collaborate on project schedule, timelines and project tracking tools for Clinical Evaluation, PMS and Post Market Clinical Follow-up (PMCF) processes for all medical devices and IVDs.
- Assist in the development and preparation of the Clinical Evaluation Plan and Clinical Evaluation Reports (CERs) per MDR 2017 / 745 and MEDDEV2.7.1 to meet essential requirements in support of submission for CE mark application to obtain Declaration of Conformity and EU market clearance, recertification and proposed indication / labeling changes, as well as CER updates to maintain EU product conformance (class IIb and III products)
- Assist in providing evaluation of clinical and safety data assessments of post-marketing events.
- Assist in creation of PMCF plans and reports, and Summary of Safety and Clinical Performance (SSCP) documents
- Conducts systematic, comprehensive searches of published clinical literature; assists in writing clear and effective generation of search protocols and reports, examination of clinical evidence and provide input to risk assessment and product labeling as well as clinical / regulatory strategies
- Stay current on clinical research and developments as well as literature related to FUJIFILM Irvine Scientific Products. Provide critical analysis and summary as needed.
- Assist with collecting, analyzing, trending and reporting on safety data to proactively identify potential adverse safety risks or performance trends.
- Ensure, in conjunction with R&D and other personnel, that the clinical requirements of the product are adequately addressed
- Assist with organization and execution of pre-launch clinical usability trials in conjunction with R&D, as needed
- Collaborate with cross-function team members to ensure compliance to applicable regulations, standards, and company policies.
- Preparation of relevant information / responses for regulatory submissions, working with other members of the RA department
- Assist in the preparation and maintenance of product registrations that include, but are not limited, to the following :
Renewal of Technical Files and communication with corresponding Agents (EU AR, China, etc.)
Internal / External and Customer Audits, as it relates to clinical data
Required Skills / Education
Salary and Benefits :
To all agencies : Please, no phone calls or emails to any employee of Fujifilm about this requisition. All resumes submitted by search firms / employment agencies to any employee at Fujifilm via-email, the internet or in any form and / or method will be deemed the sole property of Fujifilm, unless such search firms / employment agencies were engaged by Fujifilm for this requisition and a valid agreement with Fujifilm is in place. In the event a candidate who was submitted outside of the Fujifilm agency engagement process is hired, no fee or payment of any kind will be paid.
EEO Information
Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.
ADA Information
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (
fisihr@fujifilm.com
Salary : $100,090 - $130,295
