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Clinical Evaluation Specialist : 20-00127
Ref No.: 20-00127
Category: Clinical Affairs
Location: Sunnyvale, California
Primary Skills: Clinical Affairs, Clinical Evaluation Reports, CER, Medical Writing, Clinical Regulatory Documents, Regulatory Documents, Therapeutic, Surgical, Clinical Section
Duration: Long Term
Contract Type: W2 Only

Responsibilities :
  • Authoring Clinical documentation mainly the Clinical Evaluation Reports [CER] including clinical section of regulatory authority requests.
  • Acquire knowledge of therapeutic areas, competitor devices, current clinical/market developments, literature review processes and the ability to keep abreast of current literature.
  • Critically appraise scientific literature and write clinical summaries for products and surgical procedures.
  • Managing CER timelines required by product development teams and global Regulatory Bodies by utilizing the appropriate project management tools.
  • Interacting with internal teams (engineering/product development/regulatory) to define the plan and strategy for development of the Clinical evaluation reports for new products requiring CE Mark.
  • Conduct proofreading, editing, document formatting, review comment integration and document completion / approval activities.
  • Perform periodic reviews of risk documentation and product labelling; ensure appropriate updates are implemented.
  • Provide clinical perspective and support to guide new product development for CE Mark purposes.
  • 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., SOPs) and regulatory requirements (e.g., GCP and US and OUS guidelines)
  • Previous experience in the application of therapeutic and device knowledge to 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.
  • Ability to identify critical information needs and identify roles / individuals to involve for decision making within clinical evaluation assessment and report development.
  • Strong experience in conducting literature searches, reviews and appraisal of the scientific data.
  • Strong experience in protocol development, writing clinical section for regulatory submission and clinical evaluation report writing.
      To follow up with any questions, please contact Vaibhav at 408-512-2355

Akraya is an award-winning IT staffing firm and the staffing partner of choice for many leading companies across the US. We offer comprehensive benefits including Health Insurance (medical, dental, and vision), Cafeteria Plan (HSA, FSA, and dependent care), 401(k) (enrollment subject to eligibility), and Sick Pay (varies based on city and state laws).
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Akraya is committed to equal treatment and opportunity in all aspects of recruitment, selection, and employment without regard to gender, race, religion, national origin, ethnicity, disability, gender identity/expression, sexual orientation, veteran or military status, or any other category protected under the law. Akraya is an equal opportunity employer; committed to a community of inclusion, and an environment free from discrimination, harassment, and retaliation.