Post-Market Safety Evaluation Senior Technical Writer

3 months ago

St Paul, United States Abbott Laboratories Full time

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. Youâll also have access to:

  • Career development with an international company where you can grow the career you dream of.
  • 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 bachelorâs 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.
  • A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

For years, Abbottâs medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether itâs glucose monitoring system, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine ï¬ngersticks.

The Opportunity

We are seeking a Post-Market Safety Evaluation Senior Technical Writer to join Abbottâs Medical Device on-site in either St. Paul, MN or Plano, TX locations. This new team member is responsible for writing and editing PMS documents including provide technical and strategic expertise at the post-market phase of product life cycles. The individual will review/manage Post-Market Surveillance (PMS) Plans, Periodic Safety Update Reports (PSUR), PMS Reports, and Canada Summary reports (CASR).  Additionally, will interact with various cross-functional teams in order to assist in strategy, plans, and project deliverables as well as must be able to effectively manage multiple projects and timelines.

What Youâll Work On

  • With minimum supervision, collaborates with medical writers to maintain PMS plans, PSURs, PMS Reports, and CASRs for Abbott products. Identifies appropriate sources of relevant data, interpret, evaluate and incorporate information from various sources including literature, clinical data, and medical references. Works with cross-functional teams to address and correct deficiencies.
  • Creates and drafts PMS plans, PSURs, PMS Reports and CASRs as needed.
  • Creates or participates in the PMS Plan/PSUR/PMS Report/CASR timelines. Actively manages timelines and project delays/risks, develops scenarioâs and recommendations for management. Ensures project expenditures are within budgetary guidelines.
  • Technical Documentation Management and Technical Writing: Write, edit, maintain, and update PMS plans, PSURs, PMS Reports, and CASRs.
  • Facilitates communication and exchange of documents between stakeholders (e.g., internal personnel such as Regulatory Affairs, Product Performance Group (PPG), Sales and Marketing, Quality Engineering, Clinical Affairs, Risk Management, Project Management, as well as external vendors such as CROs, Medical Writers and Reviewers.
  • Maintains up-to-date understanding and experience of clinical / PMS data and risk management.
  • Contributes to the development and maintenance of PSUR/PMS Report DOP/SOP and associated documentation, provides input to cross-departmental SOPs and DOPs as needed.
  • Provide support for internal and external audits.

Required Qualifications

  • Bachelorâs degree in Science, Medical Technology or equivalent technical degree OR an equivalent combination of education and work experience.
  • 3 yearsâ 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.
  • Good written and oral communication skills. Good working knowledge of personal computer software programs in Windows environment.

Preferred Qualifications

  • Knowledge of PMS Plans / PSURs / PMS Reports/CASRs.
  • Understanding of regulations, standards and guidelines related to medical devices clinical studies and quality systems, including: MDR 2017/745; MDD 93/42/EEC; AIMDD 90/385/EEC; MEDDEV 2.7/1 Rev.  4; ISO 14971; ISO 14155; ISO 13485.
  • Effective written, verbal and presentation skills in the area of technical/clinical applications.
  • Familiar with IMDRF terminology/codes and adverse event reporting.
  • Project management experience.
  • Experience in post-market surveillance, risk management, clinical research, or regulatory affairs in medical device or pharmaceuticals industry.
  • Demonstrated ability to identify and adapt to shifting priorities and competing demands.
  • Highly-developed interpersonal skills, and strong attention to detail.

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.



The base pay for this position is $72,700.00 â $145,300.00. In specific locations, the pay range may vary from the range posted.

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