Senior Medical Writer

1 week ago

Santa Clara, California, United States Abbott Laboratories Full time
Job Opportunity

Abbott Laboratories is seeking a highly skilled Senior Medical Writer to join our team. As a Senior Medical Writer, you will play a critical role in supporting our Vascular Clinical Evaluation Products by combining your understanding of scientific and research methodology, medical device regulations and guidelines, and product knowledge to support Regulatory Affairs submissions for CE Marking of new devices and maintaining of CE Mark for existing devices.

Key Responsibilities

  • Develop and maintain Clinical Evaluation Plans, Clinical Evaluation Reports, and Summary of Safety and Clinical Performance [SSCPs], Regulatory Responses and other related documentation.
  • Identify, evaluate and summarize clinical evidence including data from sources such as clinical investigations, literature, post-market surveillance, risk, and post market clinical evaluations.
  • Review IFUs, patient guides, Risk Management files, clinical study reports, physician training materials, ensuring alignment of risk information.
  • Manage and participate in timelines of deliverables by using appropriate project management tools.
  • Communicate clearly and timely with cross functional teams and medical writers on project timelines, risks, and risk mitigation strategies.
  • Interpret results in preparation for product applications by evaluating clinical and scientific and risk data and literature, and staying abreast of current clinical practice.
  • Participate in and/or lead the development of regulatory responses for Notified Body questions upon review of submissions.
  • Facilitate communication and exchange of documents between stakeholders.

Requirements

  • Bachelor's Degree in Science, Medical Technology or a relevant technical discipline OR an equivalent combination of education and experience.
  • Minimum 3 years relevant experience in a related area such as R&D, Technical Product Development, or Quality in a healthcare industry.
  • Writing, editing and managing engineering and technical documentation utilized in the development of new products and improvement of existing products.
  • Developing spreadsheets or databases for the capture, assembly, and graphical presentation of metrics.
  • Non-product application validation - Process establishment including metrics definition, statistical analysis and analytical techniques.
  • Experience in complaint handling, operation or service of diagnostic instrumentation, or medical technology.

Preferred Qualifications

  • Bachelor's Degree in Life Sciences; Master's Degree, RN, PharmD, PhD, or MD.
  • Experience writing CERs and related documents in accordance with MEDDEV 2.7/1 Rev 4 and MDR submissions.
  • Understanding of regulations, standards and guidelines related to medical devices clinical studies, and quality systems, MDD 93/42/EEC; MDR 2017/745; MEDDEV 2.7/1 Rev. 4; ISO 14971; ISO 14155; ISO 13485.
  • Project management and/or management of people experience.
  • Excellent written, verbal and presentation skills in relevant areas of clinical/technical applications.
  • Strong command of medical and surgical terminology.
  • Demonstrated ability to identify and adapt to shifting priorities and competing demands.
  • Highly developed interpersonal skills, and strong attention to detail with accountability for ensuring deliverables are met on time.

What We Offer

  • Competitive salary range: $83,600.00 – $167,200.00.
  • Free medical coverage for employees via the Health Investment Plan (HIP) PPO.
  • An excellent retirement savings plan with high employer contribution.
  • Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
  • A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.

Apply Now

Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.

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