SantaClaraRecruiter Since 2001
the smart solution for Santa Clara jobs

Clinical Evaluation Reporting / Medical Writer (CER)

Company: Abbott Laboratories
Location: Santa Clara
Posted on: November 19, 2021

Job Description:

Clinical Evaluation Reporting / Medical Writer (CER) This job is available in 2 locations Category Medical and Clinical Affairs 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 109,000 colleagues serve people in more than 160 countries. For years, Abbott's medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it's glucose monitoring systems, 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 ---ngersticks.-- Our location in Plymouth, MN, or Santa Clara, CA currently has an opportunity for a Clinical Evaluation Reporting / Medical Writer (CER) (may be open to remote). 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 Neuromodulation, CAHF and Vascular 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 DO

  • Writes and contributes to Clinical Evaluation reporting deliverables including Clinical Evaluation Plans/Reports, PMS and PMCF 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 Sales and Marketing, R&D, Regulatory Affairs, Library Services, Product Performance Group (PPG), Quality Engineering, Clinical Affairs, Clinical Science, 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, ensuring 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. EDUCATION AND EXPERIENCE YOU'LL BRING-- Required--
    • Bachelor's Degree or an equivalent combination of education and work experience
    • 4-6 years of medical writing experience in the medical or pharmaceutical industry or 7+ years general technical writing experience required
    • Experience may include writing experience in a medical, pharmaceutical, medical device, clinical research, medical or research industry , or combination of these skills Preferred--
      • Biomedical, sciences, medicine or similar health related discipline preferred
      • CER writing experience preferred
      • Excellent written and verbal communication skills
      • Experience with collaborative, cross-functional teams.
      • Excellent analytical skills and ability to manage complex tasks and manage time effectively
      • Proficient with Word, Excel, PowerPoint, Outlook, etc. WHAT WE OFFER At Abbott, you can have a good job that can grow into a great career. We offer:--
        • Training and career development, with onboarding programs for new employees and tuition assistance
        • Financial security through competitive compensation, incentives and retirement plans
        • Health care and well-being programs including medical, dental, vision, wellness and occupational health programs--
        • Paid time off
        • 401(k) retirement savings with a generous company match--
        • The stability of a company with a record of strong financial performance and history of being actively involved in local communities-- Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.-- Location United States - Pennsylvania - Philadelphia Category Sales As appropriate, assists marketing personnel on advertising and promotional sales strategies. Builds and executes on business plans in partnership with management to identify, target and develop new accounts.... Authors and contributes to necessary documents for regulatory submissions and communications, risk reviews and other processes such as regulatory inquiries. Experience may include writing experience in... Job Id 30977730 Medical surveillance Not Applicable Division MD Medical Devices Travel Not specified Additional Location United States - Minnesota - Plymouth Significant work activities Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day),Keyboard use (greater or equal to 50% of the workday) Job available in 2 locations
          • United States - Minnesota - Plymouth PLAN FOR SUCCESS CAREER OPPORTUNITIES Our business encompasses many different functions and capabilities, which allows you to explore careers in various fields.-- GROWTH PLANNING Growth Planning and Performance Excellence is an annual process through which you'll be able to have open career discussions with your manager to help you determine your own career path and future. TRAINING & NETWORKS We provide a wide range of classroom and e-learning courses to help you develop new skills and enhance your career.-- WE'RE RECOGNIZED AROUND THE WORLD DOW JONES SUSTAINABILITY INDEX BEST CORPORATE CITIZENS FORTUNE CHANGE
            THE WORLD FORTUNE'S MOST ADMIRED COMPANIES JOIN OUR TALENT COMMUNITY We will notify you about relevant positions, and keep you in mind when we have interesting opportunities. Abbott welcomes and encourages diversity in our workforce including Minorities, Women, Individuals with Disabilities and Protected Veterans. We provide reasonable accommodation to qualified individuals with disabilities. Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company.

Keywords: Abbott Laboratories, Santa Clara , Clinical Evaluation Reporting / Medical Writer (CER), Advertising , Santa Clara, California

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

Santa Clara RSS job feeds