Abbott

Senior Medical Writer - Clinical Evaluation Reporting (CER)

Abbott • $78K — $156K *
Minneapolis, MN 55442In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in a Science, Medical Technology or equivalent technical degree or relevant work experience.
  • 3+ years relevant experience in R&D, Technical Product Development, or Quality in the healthcare industry.
  • Strong written and verbal communication skills with a focus on project management and prioritization.
  • Experience in writing, editing and managing engineering and technical documentation for new and existing products.
  • Ability to develop spreadsheets or databases for metrics assembly and presentation.
  • Knowledge of quality systems and experience in complaint handling or service of diagnostic instrumentation.

Responsibilities

  • Author and contribute to Clinical Evaluation reporting documents including plans and reports.
  • Evaluate clinical evidence from various sources for product submissions and applications.
  • Collaborate with team members and stakeholders on CER related projects and processes.
  • Support regulatory, clinical, and engineering deliverables as assigned.
  • Communicate and collaborate with various departments to complete evaluation project deliverables.
  • Maintain knowledge of assigned products and relevant data sources.
  • Review and ensure alignment of risk information in clinical and regulatory documentation.

Benefits

  • Comprehensive health and wellness benefits for employees and families.
  • Diverse career opportunities within the organization for personal and professional growth.
Full Job Description
JOB DESCRIPTION:

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.


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.

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.

ADDITIONAL LOCATIONS:

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)

About Abbott

Abbott Careers

Joining Abbott means becoming part of a globally diverse team dedicated to making a lasting impact on human health. As a leader in healthcare innovation, Abbott provides a dynamic workplace where careers flourish through growth, leadership, and diversity training.

Opportunities at Abbott

Explore a world of opportunities with our team. Whether you're seeking job opportunities in engineering, marketing, research, or healthcare, Abbott offers a variety of positions that allow professionals to grow their careers. Our commitment to diversity and innovation is evident in every aspect of our work, fostering an inclusive culture that values each team member's contribution.

Work You'll Do

At Abbott, every role contributes to our mission of helping people live fuller lives through better health. From groundbreaking research in medical devices to advancements in pharmaceuticals, our team is at the forefront of healthcare innovation. By joining Abbott, you are not just accepting a job; you are embarking on a path of professional and personal growth.

Internship Programs

Kickstart your career with an Abbott internship. Our programs provide invaluable industry experience and a chance to develop essential skills in a real-world setting. Interns at Abbott work on projects that matter, gaining the experience and knowledge necessary to succeed in their future careers.

Professional Development

Abbott is dedicated to the continuous professional development of its employees. With access to cutting-edge technology, leadership programs, and diversity training, our team members are equipped to lead and innovate within the healthcare industry. We support your career journey with robust training programs, mentorship, and opportunities for networking and professional growth.

Benefits and Culture

Our employees enjoy comprehensive benefits designed to support their life and well-being. From health insurance to retirement plans, we ensure our team has everything they need to thrive. Abbott's culture is built on a foundation of respect and integrity, united by a shared commitment to improving health outcomes.

Join Our Team

Discover the impact you can make with a career at Abbott. We are hiring individuals who are passionate, curious, and driven to lead. Search open positions that match your skills and interests on our Jobs page. Prepare your resume, sharpen your interview skills, and get ready to join a team that's at the cutting edge of healthcare solutions.

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Keep up to date with career tips, industry insights, and company news—all from the people who work here. Subscribe to our Careers Blog and personalize your subscription to receive job alerts and insider tips tailored to your preferences.

Explore Abbott

With a commitment to improving life through innovation, leadership, and diversity, Abbott is a place where you can fulfill your potential. See what exciting and rewarding opportunities await at Abbott by exploring our career opportunities today.

SEARCH ABBOTT JOBS

Join us in our mission to make the world a healthier place through innovation, leadership, and diversity. Your journey to a fulfilling career at Abbott starts here.
Learn more about Abbott
Size
113,000 employees
Market Cap
$189 billion
Industry
Healthcare
Net Income
$4.4 billion
Founded
1944
5 Year Trend
+15.6%
Revenue
$34.6 billion
NASDAQ
ABT
* Ladders Estimates

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