Medical Writer IIClinical Evaluation Reporting (CER) Medical Devices

JOB 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. Youll 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 bachelors 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 Abbotts medical device businesses have offered technologies that are faster more effective and less invasive. Whether its 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 10000 people have healthier hearts improve quality of life for thousands of people living with chronic pain and movement disorders and liberate more than 500000 people with diabetes from routine finger sticks.

The Opportunity

Our location in Maple Grove MN Plano TX Sylmar CA Atlanta GA or Santa Clara CA currently has an on-site opportunity for a Medical Writer II/ Clinical Evaluation Reporting (CER). The Medical Writer II 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 Youll 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 guidances (ISO13485 ISO14155 ISO14791 MEDDEV 2.7.1 MDR and EU and FDA guidance documents) and applicable Abbott SOPs and DOPs.

Required Qualifications

• Bachelors degree in Science Medical Technology English OR an equivalent combination of education and work experience.
• Minimum 2 years relevant professional experience in a related area such as R&D Technical Product Development Quality Regulatory Affairs Clinical Research or Medical Writing.
• 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 superior attention to detail. Ability to critically review own work before sending out for internal/external review by team.
• Ability to find and correct errors in spelling punctuation grammar consistency clarity and accuracy.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.

PreferredQualifications

• Advanced degree in science biomedical engineering medicine nursing or similar health related discipline.
• 1-4 years writing experience as a medical writer in the health care industry or 4 years general technical writing; CER writing experience
• 1-4 years experience in experimental design and data interpretation
• Knowledge of division products and or Quality systems and measures
• 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.
• 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.

Learn more about our health and wellness benefits which provide the security to help you and your family live full lives:

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.

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The base pay for this position is

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

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