Senior Medical Writer Senior Project Manager, Clinical Evaluation

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 122000 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. Youll 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 bachelors 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 Abbotts 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 Youll 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 (Bachelors) 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

• Masters 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:

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.

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The base pay for this position is

$90000.00 $180000.00

In specific locations the pay range may vary from the range posted.

Medical Writing

MD Medical Devices

United States > Santa Clara : Building A - SC

United States > Minnesota > St. Paul > Lillehei : One Lillehei Plaza

Standard

Not specified

Not Applicable

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day) Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: EEO is the Law link - Espanol: Experience:

Senior IC