Medical Writer/Clinical Evaluation Reporting (CER) - Medical Devices at Abbott Pediatrics

Burlington, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

21 Mar, 26

Salary

120000.0

Posted On

21 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Medical Writing, Clinical Evaluation, Technical Writing, Regulatory Affairs, Project Management, Analytical Skills, Communication Skills, Interpersonal Skills, Attention to Detail, Quality Engineering, Risk Management, Data Interpretation, Team Collaboration, Clinical Investigations, Documentation, Compliance

Industry

Hospitals and Health Care

Description

Working at Abbott At 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. 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 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 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 ﬁnger sticks. The Opportunity Our location in Maple Grove MN, St. Paul, MN, Sylmar, CA, Pleasanton, CA, Burlington, MA, Atlanta, GA or Santa Clara, CA currently has an on-site opportunity for a Clinical Evaluation Reporting / Medical Writer (CER). The Medical Writer on our Regulatory Clinical Evaluation team provides technical and strategic writing expertise throughout the product development and life cycle process. Daily activities are related to authoring Clinical Evaluation Reporting documents for the Heart Failure, Vascular, and Cardiac Rhythm Management products. Experience in clinical study management and design, medical, or scientific writing, and/or quality engineering/risk management and strong written and verbal communication skills are needed. What You’ll Work On Writes and contributes to Clinical Evaluation reporting deliverables including Clinical Evaluation Plans/Reports, SSCPs, Regulatory Responses and other related documentation. 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. Collaborates with team members and stakeholders in planning for and supporting CER related projects and processes. Supports additional clinical, regulatory, quality and engineering related deliverable as assigned. Effectively communicates and collaborates with Regulatory Affairs, Marketing Library Services, Product Performance Group (PPG), Quality Engineering, Clinical Affairs, Risk Management and Medical Affairs in completing clinical evaluation project related deliverables. Maintains thorough knowledge of assigned products. Identifies appropriate sources of relevant data, interprets, evaluates and incorporates information from various sources including literature, clinical data, and medical references. Reviews IFUs, Patient Guides, Risk Management files, Clinical Evaluation Protocols, Clinical Evaluation Reports and Plans (CER/CEP), physician training materials, to ensure alignment of risk information. Involved in responses to complex queries such as those issued by notified bodies and stakeholders. Authors and contributes to necessary documents for regulatory submissions and communications, risk reviews and other processes such as regulatory inquiries. Ensures quality in all deliverables and documentation with attention to detail, consistency and integrity of data. Responsible for compliance with applicable corporate and divisional policies and procedures. Ensures compliance to applicable regulations and guidance’s (ISO13485, ISO14155, ISO14791, MEDDEV 2.7.1, MDR, and EU and FDA guidance documents) and applicable Abbott SOPs and DOPs. Required Qualifications Bachelor’s degree in a relevant technical discipline OR an equivalent combination of education and work experience. 3 years’ progressively more responsible experience as a technical writer in a medical or high technology (preferably biotechnology) environment. 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. Multitasks, prioritizes and meets deadlines in timely manner. Strong organizational and follow-up skills, as well as attention to detail. Ability to work in a highly matrixed and geographically diverse business environment. Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Ability to leverage and/or engage others to accomplish projects. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Preferred Qualifications Advanced degree in science, biomedical engineering, medicine, nursing or similar health related discipline Experience in experimental design and data interpretation Knowledge of division products and or Quality systems and measures 3+ years of medical writing experience in the medical device or pharmaceutical industry or 4+ years general technical writing; CER writing experience Experience may include writing experience in a medical, pharmaceutical, medical device, clinical research, medical or research industry, or combination of these skills Understanding of medical technology Excellent analytical skills and ability to manage complex tasks and manage time effectively Proficient with Word, Excel, PowerPoint, Outlook, etc. Experience in complaint handling, operation or service of diagnostic instrumentation. Apply Now 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 $60,000.00 – $120,000.00. In specific locations, the pay range may vary from the range posted.

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Responsibilities

The Medical Writer will author Clinical Evaluation Reporting documents and evaluate clinical evidence for medical devices. They will collaborate with various teams to support clinical evaluation projects and ensure compliance with regulations.