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Clinical Writer

Company: Applied Medical
Location: Rancho Santa Margarita
Posted on: May 3, 2021

Job Description:


Applied Medical is dedicated to providing innovative products, programs and solutions that meet clinical needs and improve patient outcomes. Applied is equally committed to improving the affordability and accessibility of high-quality healthcare. Applied Medical’s team members enjoy a dynamic, team-focused environment that allows opportunity for growth in individual career paths through skills development, training and advanced business knowledge. If you would like to be a part of a company making a significant and sustainable impact on healthcare, then Applied Medical is the place for you.

As a Clinical Writer you will be responsible for working within the framework of a team and performing the following activities:

  • Lead the development and completion of scientific protocols and reports, including, but not limited to, Clinical Evaluations and Post Market Clinical Feedback as part of design validation for medical devices to support product registrations internationally
  • Maintain periodic updates and revisions of Clinical Evaluations
  • Generate protocols and reports using a well-defined scientific/research methodology
  • Conduct scientific literature reviews and compile reports, such as annual literature updates and periodic safety updates, to provide to global regulatory agencies
  • Collaborate with cross-functional teams to develop new and insightful analytics and data visualization concepts to address unique problems in clinical research
  • Create and maintain standard operating procedures and work instructions for preparation and maintenance of compliant medical writing deliverables
  • Manage timelines and communicate with team members to maintain awareness of expectations, milestones and deliverables

This position requires the following skills and attributes:

  • Advanced degree in a scientific field (MS, Ph.D., MD, or Pharm. D.)
  • Data analytic publication experience or literature author publication experience
  • Ability to understand and interpret results of clinical studies, with a strong understanding of statistics
  • Expertise in conducting focused literature searches on PubMed, MedLine or other similar literature databases
  • Programming knowledge with R, Minitab and other statistical programs
  • Ability to perform Mathematical/Statistical Analysis
  • Effective written and oral communication skills
  • Ability to formulate reports and present findings
  • Ability to collaborate in a team environment
  • Project management and organizational skills
  • Ability to prioritize and manage multiple projects
  • Strong familiarity with Microsoft Office
  • Experience in giving presentations
  • Data-mining and analysis

This following skills and attributes are preferred:

  • 3-5 years’ experience in the medical device/pharmaceutical field or 2+ years of research with professor

  • Training and mentorship with ongoing learning and development courses
  • On-campus wellness activities
  • Comprehensive medical and dental and vision coverage
  • Education reimbursement program
  • 401(k) program with discretionary employer match
  • Generous vacation accrual and paid holiday schedule

Keywords: Applied Medical, Rancho Santa Margarita , Clinical Writer, Other , Rancho Santa Margarita, California

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