Veterans Sourcing is hiring: Medical Writer in Sunnyvale

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 Intuitive 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)

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 :

• 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).
• Consistently shows dedication or strong work-ethic to help meet aggressive timelines or multiple projects when necessary.
• We are an AA / EEO / Veterans / Disabled employer.