Post-Market Safety Evaluation Senior Technical Writer (on-site)

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.
13 days ago