Senior Medical Writer / Senior Project Manager, Clinical Evaluation

Abbott; Saint Paul (MN); On-site; USD 90,000 - 180,000; Full time

Job summary

Abbott Laboratories, a global healthcare leader, seeks a Senior Medical Writer / Senior Project Manager, Clinical Evaluation to join Abbott Vascular on-site in Santa Clara, CA or Maple Grove, MN. You will combine scientific expertise, regulatory knowledge and project management to support EU CE marking submissions and ongoing clinical evaluations.

Ideal candidates have a science background, knowledge of EU MDR 2017/745, strong writing skills, and the ability to manage timelines and

Qualifications

• Scientific background in science, engineering, or medical fields; understanding of research design and statistics.
• Deep knowledge of EU MDR 2017/745, MDD, AIMDD, MEDDEV, and related medical device guidelines.
• Proven project management experience and ability to lead CER development and regulatory responses.
• Excellent written, verbal and presentation skills in clinical/technical applications.
• Ability to travel as needed (<10%).

Responsibilities

• Create and maintain Clinical Evaluation Plans, Clinical Evaluation Reports, and SSCPs.
• Identify, evaluate, and summarize clinical evidence from investigations, literature, and post-market data.
• Manage timelines of deliverables using project management tools.
• Communicate timelines and risks with cross-functional teams and writers.
• Interpret results for product applications by evaluating data and literature; stay current with clinical practice.
• Develop regulatory responses for Notified Body questions during submissions.
• Coordinate document exchange among internal and external stakeholders.
• Provide regulatory guidance on clinical data for new product development.
• Support audits and CAPA activities; participate in root cause analysis and quality metrics.
• Act as a independent decision-maker on CER-related regulatory issues.
• Execute projects within budgetary guidelines.

Skills

Scientific background

EU MDR knowledge

Project management

Academic/writing proficiency

Regulatory submissions

Cross-functional communication

Medical device experience

Clinical evaluation planning

CER writing and review

Regulatory strategy

Education

Bachelor’s degree

Master’s degree preferred

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.

Job Title

Senior Medical Writer / Senior Project Manager, Clinical Evaluation

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify forfree medical coverage in ourHealth Investment Plan (HIP) PPOmedical 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.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

We are seeking a Senior Medical Writer / Senior Project Manager, Clinical Evaluation to join Abbott’s Vascular Division on-site in Santa Clara, CA or Maple Grove, MN. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for the treatment of vascular disease.

The primary function of a Senior Medical Writer / Senior Project Manager, Clinical Evaluation is to combine 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.

What You'll Work On

• 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.

Required Qualifications

• 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%).

Preferred Qualifications

• 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.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:

www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews.

The base pay for this position is $90,000.00 – $180,000.00. In specific locations, the pay range may vary from the range posted.