The position will mainly focus supporting the inhouse team with the Clinical Evaluation Reports (CERs), with potential for future additional responsibility for development of other clinical evidence documents. The purpose of this job is to support clinical evaluation reports (CERs) per Medical Device Regulation (MDR), 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.
Responsibilities:
This position has responsibility and authority for: Authoring sections of Clinical documentation as part of the Clinical Evaluation Reports [CER].
Acquire knowledge of therapeutic areas, literature review processes and the ability to keep abreast of current literature.
Participates in and/or performs comprehensive literature searches to develop in-depth knowledge and understanding of current scientific literature required to support identified product lines and related clinical studies.
Work with the clinical librarian to help with conducting literature searches on products/product families
Review the scientific literature and critically appraise and write clinical summaries for products and surgical procedures
Support the internal team members by adhering to CER timelines and providing data in a timely manner to support global Regulatory activities.
Interacting with internal teams to understand the plan and strategy for development of the Clinical evaluation reports for new and existing products.
Conduct proofreading, editing, document formatting, review comment integration and document completion / approval activities.
May assist with creation of clinical content including the preparation of manuscripts, scientific abstracts, conference presentations and posters based on clinical trials.
May author Protocols and/or routine Clinical Study Progress Reports.
Ensure compliance with corporate (e.g., SOP’s) and regulatory requirements (e.g., GCP and US and OUS guidelines).
Required experience:
Previous experience in the application of therapeutic and device knowledge to support the development of clinical evaluation reports.
Must have a minimum of 2-4 years of medical writing experience
Minimum of 0-2 years of experience in clinical evaluation report writing in a medical device industry is preferred.
Strong experience in conducting literature searches, reviews and appraisal of the scientific data.
Demonstrated ability to clearly and effectively communicate verbally and in technical or scientific writing; demonstrated effective scientific writing skills.
Excellent critical and analytical thinking skills. MD, PhD or M.S. degree in scientific field is desired.
Must have high level of attention to detail and accuracy.
Must be able to work effectively with internal team members.
Must be able to manage multiple projects across numerous surgical disciplines.
Strong communication, presentation and interpersonal skills with high attention to detail and organization
Strong experience in protocol development and writing clinical section for regulatory submission.
Ability to learn quickly and self-educate on different surgical specialties as applicable to medical products and procedures (Self-starter attitude).
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