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 114,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION:Working at AbbottAt Abbott, you can do work that matters, grow, and learn, care for yourself and 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.Free medical coverage for employees* via the Health Investment Plan (HIP) PPOAn excellent retirement savings plan with high employer contributionTuition 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 around the world 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 a best place to work for diversity, working mothers, female executives, and scientists.For years, Abbott's medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it's glucose monitoring system, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.The Opportunity The function of a Senior Medical Writer/Project Manager supporting our Vascular Clinical Evaluation Products combines understanding of scientific and research methodology, medical device regulations and guidelines, and product knowledge, to support Regulatory Affairs submissions for CE Marking of new devices and maintaining of CE Mark for existing devices in accordance with the European Commission Guidelines on Medical Devices: Clinical Evaluation : A Guide for Manufacturers and Notified Bodies under Directives 93/42/EEC and 90/385/EEC (2016)requirements (MEDDEV 2.7/1 Rev 4) and EU Regulation 2017/745.The CER Writer/PM is recognized as a subject matter expert for guidelines and regulations regarding the clinical evaluation process and its consequent documents (e.g., CEP, PMS/PMCF Plan, SSCP and PSUR, and CER). As such, this person has oversight of one or more medical writers guiding the development, or update, of CERs and CER-related documents. In addition, the CER Writer/PM will interact cross-functionally with various personnel to identify and obtain relevant documentation and data on safety, performance, adverse events and risk/benefit profile of a device or devices. Moreover, the CER Writer/PM may be requested to contribute to other activities such as risk assessment and management, and review of informational documents like the Instructions for Use. The CER Writer/PM will sit on core team product development, CER-related SOP development and revision, and interact with regulatory agencies' representatives as needed. The role of Scientific CER Writer/PM plays a significant part in new product development, as well as in the subsequent evaluation of the safety and performance of a device over its lifecycle. The position reports to the Sr. Manager of Clinical Evaluations Global Regulatory Operations.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 documentationIdentifies, 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. Reviews IFUs, patient guides, Risk Management files, clinical study reports, physician training materials, ensuring alignment of risk information.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 writersInterprets results in preparation for product applications by evaluating clinical and scientific and risk data and literature, and staying abreast of current clinical practiceParticipate 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 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.Required Qualifications Bachelor's Degree in Science, Medical Technology or a relevant technical discipline OR an equivalent combination of education and experience Minimum 3 years relevant experience in a related area such as R&D, Technical Product Development, or Quality in a healthcare industry.Writing, editing and managing engineering and technical documentation utilized in the development of new products and improvement of existing products. Developing spreadsheets or databases for the capture, assembly, and graphical presentation of metrics. Non-product application validation - Process establishment including metrics definition, statistical analysis and analytical techniques. Experience in complaint handling, operation or service of diagnostic instrumentation, or medical technology.Must possess comprehensive written and verbal communication, interpersonal, presentation, analytical, project management skills and the ability to prioritize and handle a large volume of projects simultaneously and meet deadlines. Preferred Qualifications Bachelor's Degree in Life Sciences; Master's Degree, RN, PharmD, PhD, or MDExperience writing CERs and related documents in accordance with MEDDEV 2.7/1 Rev 4 and MDR submissionsUnderstanding of regulations, standards and guidelines related to medical devices clinical studies, and quality systems, MDD 93/42/EEC; MDR 2017/745; MEDDEV 2.7/1 Rev. 4; ISO 14971; ISO 14155; ISO 13485Project management and/or management of people 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.Highly developed interpersonal skills, and strong attention to detail with accountability for ensuring deliverables are met on time.Technical writing experience in the medical or pharmaceutical, clinical research, medical or research industry, or combination of these skillsExperience in Cardiovascular devices.Certification is a plus (e.g., RAC and PMP).Apply Now* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.comFollow 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 $83,600.00 - $167,200.00In specific locations, the pay range may vary from the range posted.JOB FAMILY:Medical Writing DIVISION:MD Medical Devices LOCATION:United States > Santa Clara : Building A - SC ADDITIONAL LOCATIONS:WORK SHIFT:Standard TRAVEL:Yes, 5 % of the Time MEDICAL SURVEILLANCE:No SIGNIFICANT WORK ACTIVITIES:Awkward/forceful/repetitive (arms above shoulder, bent wrists), Continuous sitting for prolonged periods (more than 2 consecutive hours 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: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf