Medical Writer/ Clinical Evaluation Reporting
Medical Writer/ Clinical Evaluation Reporting
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$ 60000 - 120000
1 Vacancy
Job Description
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 nger sticks.
The Opportunity
Our location in Maple Grove MN or St. Paul MN or Santa Clara CA currently has an on-site opportunity for a Medical Writer / Clinical Evaluation Reporting (CER). 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 Structural Heart and Electrophysiology 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 a relevant technical discipline OR an equivalent combination of education and work experience.
- 3 years progressively more responsible experience as a technical writer in a medical or high technology (preferably biotechnology) environment.
- 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 attention to detail.
- 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.
- 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
- 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 4 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:
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 on Facebook at and on Twitter @AbbottNews.
The base pay for this position is
$60000.00 $120000.00In 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:
United States > Minnesota > St. Paul > Lillehei : One Lillehei Plaza United States > Santa Clara : Building A - SC
WORK SHIFT:
Standard
TRAVEL:
Yes 5 % of the Time
MEDICAL SURVEILLANCE:
No
SIGNIFICANT WORK ACTIVITIES:
Awkward/forceful/repetitive (arms above shoulder bent wrists) Continuous sitting for prolonged periods (more than 2 consecutive hours 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: EEO is the Law link - Espanol:
Employment Type
Full-Time
Key Skills
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