Abbott Laboratories
Senior Project Manager, Post-Market Safety Evaluation
Abbott Laboratories, Santa Clara, California, us, 95053
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life‑changing technologies spans diagnostics, medical devices, nutritionals and branded generic medicines, and our 103,000 colleagues serve people in more than 160 countries.
Senior Project Manager, Post-Market Safety Evaluation Job Description In this role, you will provide technical and strategic expertise at the post‑market phase of product life cycles. You review and manage Post‑Market Surveillance (PMS) Plans, Periodic Safety Update Reports (PSURs) and PMS Reports, collaborating with cross‑functional teams to develop strategy, plans and project deliverables. You must effectively manage multiple projects and timelines.
With minimum supervision, collaborate with medical writers to create and maintain PMS plans, PSURs and PMS Reports for Abbott products; identify appropriate sources of data, interpret, evaluate and incorporate information from literature, clinical data and medical references.
Create or participate in the PMS Plan/PSUR/PMS Report timelines, actively managing project schedules, addressing delays and risks, and developing scenarios and recommendations for management while ensuring project expenditures remain within budgetary guidelines.
Facilitate communication and document exchange between stakeholders, including internal teams (Regulatory Affairs, Product Performance Group, Sales and Marketing, Quality Engineering, Clinical Affairs, Risk Management, Project Management) and external vendors such as CROs, medical writers and reviewers.
Maintain an up‑to‑date understanding of clinical/PMS data and risk management practices.
Contribute to the development and maintenance of PSUR/PMS Report DOPs, SOPs and associated documentation, providing input to cross‑departmental processes as needed.
Required Qualifications
Bachelor’s degree (or equivalent combination of education and experience) in a related field.
Minimum 4 years of related work experience with solid understanding of specified functional area.
Broad knowledge and application of business concepts, procedures and practices.
Ability to perform this job in a quality system environment; failure to do so may result in non‑compliance with governmental regulations.
Skill in applying professional concepts and company policies to solve routine problems.
Capability to handle problems of limited scope independently, making required decisions.
Preferred Qualifications
Bachelor’s degree required; advanced degree preferred (science, medicine or related discipline).
Minimum 6+ years of related experience with understanding of specified functional area.
Knowledge of PMS Plans, PSURs, PMS Reports, CERs and related documents in accordance with MDR 2017/745.
Understanding of regulations, standards and guidelines related to medical devices, clinical studies and quality systems (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 technical/clinical applications.
Familiarity 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 pharmaceutical industry.
Demonstrated ability to identify and adapt to shifting priorities and competing demands.
Highly developed interpersonal skills and strong attention to detail.
Compensation The base pay for this position is $86,700.00 – $173,300.00. In specific locations, the pay range may vary from the range posted.
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Senior Project Manager, Post-Market Safety Evaluation Job Description In this role, you will provide technical and strategic expertise at the post‑market phase of product life cycles. You review and manage Post‑Market Surveillance (PMS) Plans, Periodic Safety Update Reports (PSURs) and PMS Reports, collaborating with cross‑functional teams to develop strategy, plans and project deliverables. You must effectively manage multiple projects and timelines.
With minimum supervision, collaborate with medical writers to create and maintain PMS plans, PSURs and PMS Reports for Abbott products; identify appropriate sources of data, interpret, evaluate and incorporate information from literature, clinical data and medical references.
Create or participate in the PMS Plan/PSUR/PMS Report timelines, actively managing project schedules, addressing delays and risks, and developing scenarios and recommendations for management while ensuring project expenditures remain within budgetary guidelines.
Facilitate communication and document exchange between stakeholders, including internal teams (Regulatory Affairs, Product Performance Group, Sales and Marketing, Quality Engineering, Clinical Affairs, Risk Management, Project Management) and external vendors such as CROs, medical writers and reviewers.
Maintain an up‑to‑date understanding of clinical/PMS data and risk management practices.
Contribute to the development and maintenance of PSUR/PMS Report DOPs, SOPs and associated documentation, providing input to cross‑departmental processes as needed.
Required Qualifications
Bachelor’s degree (or equivalent combination of education and experience) in a related field.
Minimum 4 years of related work experience with solid understanding of specified functional area.
Broad knowledge and application of business concepts, procedures and practices.
Ability to perform this job in a quality system environment; failure to do so may result in non‑compliance with governmental regulations.
Skill in applying professional concepts and company policies to solve routine problems.
Capability to handle problems of limited scope independently, making required decisions.
Preferred Qualifications
Bachelor’s degree required; advanced degree preferred (science, medicine or related discipline).
Minimum 6+ years of related experience with understanding of specified functional area.
Knowledge of PMS Plans, PSURs, PMS Reports, CERs and related documents in accordance with MDR 2017/745.
Understanding of regulations, standards and guidelines related to medical devices, clinical studies and quality systems (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 technical/clinical applications.
Familiarity 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 pharmaceutical industry.
Demonstrated ability to identify and adapt to shifting priorities and competing demands.
Highly developed interpersonal skills and strong attention to detail.
Compensation The base pay for this position is $86,700.00 – $173,300.00. In specific locations, the pay range may vary from the range posted.
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