Clinical Evaluation Reporting / Medical Writer (CER)
Company: Abbott Laboratories
Location: Santa Clara
Posted on: May 3, 2021
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
- 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
- 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
EDUCATION AND EXPERIENCE YOU'LL BRING
- Bachelor's Degree or an equivalent combination of education and
- 4-6 years of medical writing experience in the medical or
pharmaceutical industry or 7+ years general technical writing
- Experience may include writing experience in a medical,
pharmaceutical, medical device, clinical research, medical or
research industry , or combination of these skills
- Biomedical, sciences, medicine or similar health related
- 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
Learn more about our benefits that add real value to your life
to help you live fully: www.abbottbenefits.com
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.
Connect with us at www.abbott.com, on Facebook at
www.facebook.com/Abbott and on Twitter @AbbottNews and
Keywords: Abbott Laboratories, Santa Clara , Clinical Evaluation Reporting / Medical Writer (CER), Other , Santa Clara, California
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