Description:
Job Title: Medical Writer 3
Department: Medical Sciences/Clinical Affairs
Reports to: Senior Manager, Medical Sciences
Joining Intuitive Surgical means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and decreasing surgical invasiveness, with patient safety as our highest priority.
Primary Function of Position:
This contract-to-hire Medical Writer position reports to Sr. Manager, Medical Sciences and requires a strong candidate with significant experience in medical writing of Clinical Evaluation Reports per EU MDR, in support of submission for CE Mark application as well as CER updates to maintain EU product conformance. Potential for future additional responsibility include authoring other clinical and regulatory documents as well as abstracts and manuscripts for publication. The position will work with the in-house team and support the writing and review of these documents.
Roles and Responsibilities:
This position has responsibility and authority for the following:
Authoring Clinical documentation mainly the Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER) including clinical section of regulatory authority requests
Authoring sections of other clinical documents such as the Clinical Literature Analysis Report (CLAR), Clinical Study Report (CSR), Annual Progress Report (APR), Clinical Study Protocols and Investigator Brochures (IB)
Acquiring knowledge of therapeutic areas, literature review processes and the ability to keep abreast of current literature
Participating in and/or performing comprehensive literature searches to develop in-depth knowledge and understanding of current scientific literature required to support identified product lines and related clinical studies and stay informed about applicable clinical landscapes and trends
Working with the clinical librarian to help with conducting literature searches on products/product families
Review of scientific literature and critically appraising, analyzing and writing clinical summaries for products and surgical procedures
Writing of abstracts and development of posters for conference presentations and writing and reviewing manuscripts for publication
Proofreading, editing, inserting and formatting references, document formatting, review comment integration and document completion / approval activities.
Ensuring compliance with corporate (e.g., SOP s) and regulatory requirements (e.g., GCP and US and OUS guidelines)
Skill/Job Requirements:
Competency Requirements: (Competency is based on education, training, skills and experience).
In order to adequately perform the responsibilities of this position the individual must have the following:
Must have a minimum of 4+ years of medical writing experience.
Minimum of 0-2 years of experience in clinical evaluation report writing in medical device industry is preferred.
Previous experience in the application of therapeutic and device knowledge to support the development of clinical evaluation reports
Strong experience in conducting literature search, reviewing and appraisal and interpretation of scientific data
Demonstrated ability to clearly and effectively communicate verbally and through technical or scientific writing, excellent scientific writing skills
Excellent critical and analytical thinking skills
MD, PhD or M.S. degree in a scientific field is desired.
Must have a 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 multiple surgical disciplines.
Strong communication, presentation and interpersonal skills and excellent project management and organizational skills
Ability to learn quickly and self-educate on different surgical specialties as applicable to medical products and procedures (self-starter attitude)
Consistently shows dedication and strong work-ethic to help meet aggressive timelines and manages multiple writing projects when necessary.
No
Additional Details
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