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Post-Market Safety Evaluation Senior Technical Writer (on-site)
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locations
United States - Minnesota - St. Paul
United States - Texas - Plano
time type
Full time
posted on
Posted 2 Days Ago
job requisition id
********
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.
JOB DESCRIPTION:
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. You'll 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 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.
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, Abbott's medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it's 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 fingersticks.
The Opportunity
We are seeking a
Post-Market Safety Evaluation Senior Technical Writer
to join Abbott's 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 You'll 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 scenario's 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
Bachelor's degree in Science, Medical Technology or equivalent technical degree OR an equivalent combination of education and work experience.
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.
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 – $145,300.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Medical Writing
DIVISION:
MD Medical Devices
LOCATION:
United States > Minnesota > St. Paul > Tech Center : One St Jude Medical Drive
ADDITIONAL LOCATIONS:
United States > Texas > Plano : 6901 Preston Road
WORK SHIFT:
Standard
TRAVEL:
Yes, 5 % of the Time
MEDICAL SURVEILLANCE:
No
SIGNIFICANT WORK ACTIVITIES:
Awkward/forceful/repetitive
(arms above shoulder, bent wrists), Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)Abbott is an Equal Opportunity Employer of
Minorities/Women/Individuals
with
Disabilities/Protected
Veterans.EEO is the Law link - English:
http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol:
http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
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Abbott
is about the power of health. For more than 135 years,
Abbott
has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it's next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.
The people of
Abbott
come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life's greatest health challenges.
We invite you to explore opportunities at
Abbott
, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer,
Abbott
welcomes and encourages diversity in our workforce.
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