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Abbott · 9 hours ago

Senior Project Manager Clinical Evaluation

United States - Minnesota - Maple Grove

Full-time

Onsite

Mid, Senior Level

$78K/yr - $156K/yr

3+ years exp

Abbott is a global healthcare leader that helps people live more fully at all stages of life. They are seeking a Senior Project Manager for Clinical Evaluation to oversee the writing and editing of Clinical Evaluation Reports and manage timelines for deliverables while ensuring compliance with medical device regulations.

BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical

H1B Sponsor Likely

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

Qualification

Regulatory AffairsClinical Evaluation ReportsMedical Device RegulationsProject ManagementClinical ResearchGxPs GCPsGxPs GLPsGxPs GMPsISO StandardsAnalytical ThinkingAttention to DetailInterpersonal SkillsWritten Communication

Required

Bachelors Degree (± 16 years), in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred

Minimum 2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area

Minimum 3-4 years experience in a regulated industry (e.g., medical products, nutritionals). Note: Higher education may compensate for years of experience

Regulatory history, guidelines, policies, standards, practices, requirements and precedents

Regulatory agency structure, processes and key personnel

Principles and requirements of applicable product laws

Submission/registration types and requirements GxPs (GCPs, GLPs, GMPs)

Principles and requirements of promotion, advertising and labeling

International treaties and regional, national, local and territorial trade requirements, agreements and considerations

Domestic and international regulatory guidelines, policies and regulations

Ethical guidelines of the regulatory profession, clinical research and regulatory process

Pay strong attention to detail

Manage project

Create project plans and timelines

Think analytically

Organize and track complex information

Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results

Has broad knowledge of various technical alternatives and their potential impact on the business

Exercise good and ethical judgment within policy and regulations

Use in-depth knowledge of business functions and cross group dependencies/ relationships Define regulatory strategy with supervision Follow scientific arguments, identify regulatory scientific data needs and with supervision solve regulatory issues

Preferred

A college degree (Bachelor's) is required; in the life sciences (nursing, medicine, biomedical engineering)

Experience writing CERs and related documents in accordance with MEDDEV 2.7/1 Rev 4 and MDR submissions

3-5+ years of experience in clinical research, quality systems, or regulatory experience in medical device

Understanding of regulations, standards and guidelines related to medical devices clinical studies, and quality systems, MDR 2017/745; 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

Strong command of medical and surgical terminology

Project management and/or management of people experience

Demonstrated ability to identify and adapt to shifting priorities and competing demands

Highly developed interpersonal skills, and strong attention to detail with accountability for ensuring deliverables are met on time

Post graduate degree (Masters or Doctorate) preferred in the life sciences (nursing, medicine, biomedical engineering)

Experience in structural heart / structural intervention devices

Certification is a plus (e.g., RAC and PMP)

MD / PhD/RN/Pharm D with good written skills

Company

Abbott

Glassdoor3.8

Abbott is a healthcare company that produces diagnostic kits, medical devices, nutritional products, and branded generic medicines.

Founded in 1888

Illinois City, Illinois, USA

10001+ employees

https://www.abbott.com

H1B Sponsorship

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