Senior Medical Writer / Senior Project Manager, Clinical Evaluation

Abbott • Saint Paul, SC

9d • Onsite

About The Position

The Senior Medical Writer / Senior Project Manager, Clinical Evaluation will join Abbott’s Vascular Division. This role combines understanding of scientific and research methodology, medical device regulations and guidelines, and product and therapeutic area knowledge to support Regulatory Affairs medical device submissions in the EU for CE Marking of new devices and maintaining of CE Mark for existing devices in accordance with MEDDEV 2.7/1 Rev 4, MDD, MDCG Guidance documents, and EU MDR 2017/745.

Requirements

• A college degree (Bachelor’s) is required.
• Scientific/research background; training and degree in science, engineering, or medical fields; understanding of research design, methodology, and statistics.
• Must have thorough understanding of the EU MDR 2017/745, MDD 93/42/EEC; AIMDD 90/385/EEC; MEDDEV 2.7/1 Rev 4, MDCG Guidances on clinical evaluations, SSCP, PMCF plans and reports, and other international harmonized standards and guidelines related to medical devices, clinical studies, and quality systems.
• Project management experience.
• Excellent written, verbal and presentation skills in relevant areas of clinical/technical applications.
• Strong command of medical and surgical terminology.
• Demonstrated ability to identify and adapt to shifting priorities and competing demands.
• Proven ability to deliver high-quality work within tight timelines.
• Highly-developed interpersonal skills, and strong attention to detail.
• Able to travel as needed (<10%).

Nice To Haves

• Master’s Degree, RN, PharmD, PhD, or MD preferred.
• 5-7+ years of experience in clinical research, clinical affairs, regulatory affairs, or quality systems, in the medical device or pharmaceuticals industry.
• 3-5+ years of experience writing, reviewing or leading development of CERs and related documents in accordance with MEDDEV 2.7/1 Rev 3 and 4, the medical device directives (MDD 93/42/EEC; AIMDD 90/385/EEC) and the EU MDR 2017/745.
• Knowledge of Cardiovascular devices and technologies.

Responsibilities

• Independently creates and maintains Clinical Evaluation Plans, Clinical Evaluation Reports, and Summary of Safety and Clinical Performance [SSCPs], Regulatory Responses and other related documentation.
• Identifies, evaluates and summarizes clinical evidence including data from sources such as clinical investigations, literature, post-market surveillance, risk, and post market clinical evaluations.
• Analyzes results in preparation for product applications and submissions.
• 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.
• 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 Engineering, Clinical Engineering, A&P and Marketing, Library Services, Quality Engineering, Post-market Surveillance Group, Clinical Affairs, Risk Management, Program Management, as well as external vendors such as CROs, Medical Writers and Physician Reviewers).
• Provide strategic guidance on regulatory requirements, pertaining to clinical data and clinical evaluations, to new product development teams and sustaining teams.
• Participate in and support internal and external 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.
• Execute projects within budgetary guidelines.

Benefits

• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior