Senior Project Manager, Clinical Evaluation at Abbott

Maple Grove, Minnesota, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical DevicesIndustries

Requirements

Associates Degree (± 13 years)
Minimum 7 years

Responsibilities

Manage medical writers’ efforts in writing and editing of scientific content of deliverables, and the timelines of these documents
Creates, manages, or participates in timelines of deliverables by using appropriate project management tools
Clearly and timely communicates the timelines, project risks, and risk mitigation strategies with cross functional teams and medical writers
Interprets results in preparation for product applications by evaluating clinical and scientific and risk data and literature, and staying abreast of current clinical practice
Write and edit, as needed, Clinical Evaluation Plans and Clinical Evaluation Reports, and other clinical CER deliverables
Participate in and/or lead the development of regulatory responses for Notified Body questions upon review of submissions
Facilitate communication and exchange of documents between stakeholders (e.g., internal personnel such as Regulatory Affairs, R&D, Clinical R&D, Sales and Marketing, Library Services, Quality Engineering, Clinical Affairs, Risk Management, Project Management, as well as external vendors such as CROs, Medical Writers and Reviewers)
Provide strategic guidance on regulatory requirements pertaining to clinical data and clinical evaluation to new product development teams and sustaining teams
Participate in and support audits and responses to audit findings as appropriate, in root cause analysis, preventive or corrective actions, effectiveness monitoring, and other quality metrics
Function independently as a decision-maker on CER-related regulatory issues and must assure that deadlines are met
Execute projects within budgetary guidelines

Skills

Key technologies and capabilities for this role

Clinical EvaluationMEDDEV 2.7/1 Rev 4EU MDR 2017/745CERCEPPMSPMCFSSCPPSURMedical Device RegulationsRegulatory AffairsRisk ManagementMedical Writing OversightCross-functional Collaboration

Questions & Answers

Common questions about this position

What is the employment type for this Senior Project Manager role?

The position is full-time.

Is this Senior Project Manager position remote or office-based?

This information is not specified in the job description.

What key skills are required for the Clinical Evaluation Project Manager?

The role requires understanding of scientific and research methodology, medical device regulations and guidelines like MEDDEV 2.7/1 Rev 4 and EU Regulation 2017/745, product knowledge, project management skills including timeline creation and risk mitigation, and expertise in clinical evaluation documents such as CER, CEP, PMS/PMCF Plan.

What does the team structure look like for this role at Abbott?

The position reports to the Sr. Manager of Clinical Evaluations Global Regulatory Operations, involves oversight of one or more medical writers, and requires cross-functional interactions with various personnel and core team product development.

What makes a strong candidate for this Senior Project Manager position?

Strong candidates are subject matter experts in clinical evaluation guidelines and regulations, with experience managing medical writers, project timelines, cross-functional teams, and deliverables like CERs, CEP, and regulatory responses.

Abbott

Healthcare solutions in diagnostics and devices

About Abbott

Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.

Lake Bluff, IllinoisHeadquarters

1888Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

Departure of key leader Dr. Adamson may affect Abbott's Heart Failure division.

Integration challenges with Medtronic could impact glucose monitor-insulin pump rollout.

Thermo Fisher's microfluidics expansion may increase competition for Abbott.

Differentiation

Abbott integrates continuous glucose monitoring with automated insulin delivery systems.

Abbott's microfluidic devices streamline diagnostic processes efficiently.

Abbott's neuromodulation products target specific nervous system areas for chronic pain relief.

Upsides

Microfluidic technology offers cost-effective solutions in diagnostics.

Strategic partnerships like Abbott-Medtronic enhance product offerings and market reach.

Significant investments indicate strong market confidence in Abbott's healthcare solutions.

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