Senior Medical Writer - Clinical Evaluation Reporting (CER)

Abbott; Santa Clara (CA); On-site; USD 78,000 - 156,000; Full time

Benefits offered by this job

Medical coverage (HIP PPO)

Retirement plan with employer contrib.

Tuition reimbursement / FreeU

Job summary

Abbott is seeking a Senior Medical Writer, Clinical Evaluation, to join our Regulatory Clinical Evaluation team at our U.S. sites. You will author Clinical Evaluation Reports and related regulatory documents for Neuromodulation, CAHF, and Vascular products.

You will evaluate clinical evidence, collaborate with stakeholders, and ensure compliant deliverables across product lifecycles, with emphasis on quality and regulatory standards. Maple Grove MN/Santa Clara CA sites offer on-site roles.

Qualifications

• Bachelor’s degree in Science or equivalent.
• 3+ years in R&D, technical product development, or quality in healthcare.
• Strong written and verbal communication, multitasking and prioritization.
• Experience writing engineering/technical documentation for new products.

Responsibilities

• Author CERs, CEPs, PMS/PMCF plans and reports.
• Summarize clinical evidence from literature and studies.
• Collaborate with cross-functional teams on CER projects.
• Support regulatory submissions and inquiries and risk management.
• Ensure quality and regulatory compliance of deliverables.

Skills

Clinical writing

Regulatory writing

Quality systems

Project management

Communication

Education

Bachelor’s degree in science

Job description

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 122,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

Working at Abbott

At Abbott, you can do work that matters, grow, learn, care for yourself and your 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 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 bachelor’s 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

Our location in Maple Grove MN, St. Paul, MN, Plymouth, MN, Plano TX or Santa Clara, CA currently has an on-site opportunity for a Senior Medical Writer, Clinical Evaluation. The Sr. 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 Work On

• 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.

Required Qualifications

• Bachelor’s degree in a Science, Medical Technology or equivalent technical degree OR an equivalent combination of education and work experience.

• Minimum 3 years’ relevant experience in a related area such as R&D, Technical Product Development, or Quality in a healthcare industry.

• 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.

• 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.

Preferred Qualifications

• Advanced degree in science, biomedical engineering, medicine, nursing or similar health related discipline

• Experience in experimental design, data interpretation, and summarizing clinical data.

• Knowledge of division products and or Quality systems and measures

• 3+ years of medical writing experience in the medical device or pharmaceutical industry or 7+ years general technical writing; CER writing experience

• Relevant experience in a related area such as Clinical Research, Product Development or Quality or in a healthcare industry.

• Writing, editing and managing clinical and technical documentation utilized in the development of new products and improvement of existing products.

• 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 or medical technology.

• Experience working in a broader enterprise/cross-division business unit model.

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

$78,000.00 – $156,000.00

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

JOB FAMILY:

Medical Writing

DIVISION:

MD Medical Devices

LOCATION:

United States > Maple Grove : 6820 Wedgwood Road N.

WORK SHIFT:

Standard

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

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: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf