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Post-Market Safety Evaluation Principal Medical Writer

3 months ago

St Paul, United States Abbott Laboratories Full time

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 Principal Medical Writer to join Abbottâs Medical Device on-site in either St. Paul, MN or Plano, TX locations. This new team member will be an experienced Medical Writer with a strong career history of contributions to Post-Market Safety Evaluation (PMSE) group, including involvement with best practices/tools/applications and surveillance of changes in Medical Writing per EU and Canada regulatory guidelines. The Principal Medical Writer will provide technical and strategic expertise at the post-market phase of product life cycles. Writes/manages Periodic Safety Update Reports (PSUR), Canada Summary Reports (CASR), Post-Market Surveillance (PMS) Report, and PMS Plans, and interacts with various cross-functional teams in order to assist in strategy, plans, and project deliverables. Must be able to effectively manage multiple projects and timelines.

What Youâll Work On

  • 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).
  • Propose and implement process improvements, identifying CFT members, obtaining stakeholder agreement, presenting recommendations to upper management, and executing steps to implement.
  • Oversees COs, actively manages timelines and project delays/risks, and develops scenarios and recommendations for management.
  • Creates, manages, or participates in PSUR/PMS Report timelines and budgets by selecting providers or external medical writers, managing vendor contracts as requested, and ensuring expenditures are within budgetary guidelines.
  • Maintains up-to-date understanding and experience of clinical / PMS data and risk management.
  • Facilitates regulatory submissions and communications by communicating with Regulatory Affairs during the submission process.
  • Develops and maintains PSUR/CASR/PMS Report/PMS Plan DOPs/SOPs and associated documentation; provides input to cross-departmental SOPs and DOPs as needed; leads and oversees the process improvement to CASRs.
  • Independently creates and maintains PSURs, PMS Reports, CASRs, and PMS Plans for Abbott products. Maintain thorough knowledge of assigned products. Identify appropriate sources of relevant data, interpret, evaluate, and incorporate information from various sources including literature, clinical data, and medical references.
  • Participates in and supports audits. May actively participate in root cause analysis. May participate in root cause analysis, preventive or corrective actions, and effectiveness monitoring.

Required Qualifications

  • Bachelorâs Degree
  • 8 yearsâ experience in the medical device industry
  • 6 years of significant medical writing experience

Preferred Qualifications

  • Advanced degree  
  • Must have well developed written, oral, interpersonal and negotiation skills.
  • Leadership competency including organizational development and project management skills.
  • 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 $95,000.00 â $190,000.00. In specific locations, the pay range may vary from the range posted.