Principal Medical Writer

Abbott • Pleasanton, CA • 2h ago

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 114,000 colleagues serve people in more than 160 countries.

Working at Abbott

At Abbott, you can do work that matters, grow, and 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 for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.

An excellent retirement savings plan with a high employer contribution

Tuition reimbursement, the Freedom 2 Save (https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program, and FreeU (https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) 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

This position works Remote for our Structural Heart division.

Job Summary: Experienced Medical Writer with a strong career history of contributions to Medical Writing group, including involvement with best practices/tools/applications and surveillance of changes in Medical Writing norms per American Medical Writers Association guidelines. The Principal Medical Writer applies advanced knowledge within or across multiple disciplines and leads special projects while overseeing the on-the-job training aspects for all Medical Writers on the team. Serves as Medical Writer subject matter expert on Medical Writing tasks.

What You'll Work On

Manage all project tasks for the department's most complicated, urgent, high visibility, or challenging projects; lead CFT meetings to drive to resolution and project task completion. Propose and implement process improvements, including writing process improvement charters, identifying CFT members, obtaining stakeholder agreement, presenting recommendations to upper management, and executing steps to implement. Train team members on guides, templates, checklists and/or job tools, good writing practices and Medical Writing norms. Develop and maintain training strategy for team members and ensure team members are trained. Review training expectations and strategies with management to ensure adequate training completion as well as for alignment with team members' development plans. Maintain the guides used to create instructions for use documents and associated DIV form used to document source documents used in labeling creation; implement current regulatory feedback, ensure guide is correct/accurate and reflects most current information. Lead CFT meetings to obtain agreement on changes with stakeholders. Participate on and present changes to Labeling Process Community. Maintain the best practice document and chapter templates used for outside-of-US submission document creation. Implement current regulatory feedback from country affiliate managers, ensure best practice is correct/accurate and reflects most current information. Lead CFT meetings to obtain agreement on changes with stakeholders. Participate on and present changes to IRIS Process Community. Maintain templates and checklists used for US submission document creation. Implement current regulatory feedback, ensure templates are correct/accurate and reflect most current information. Lead CFT meetings to obtain agreement on changes with stakeholders. Present changes to users. Stay up-to-date on eSTAR versions and assess new versions for impact on templates and checklists. Maintain study record templates and user guides for study record creation. Implement current regulatory feedback, ensure templates and user guides are correct/accurate and reflect most current information. Lead CFT meetings to obtain agreement on changes with stakeholders. Create new templates/user guides as new study designs are created. Present changes to users. Maintain troubleshooting guide templates. Implement global service and support feedback. Present changes to users.

Required Qualifications

-Education: PHD, Masters or MD in Lifesciences or Engineering

-Strong communication skills both written and verbal

-Experience on the Clinical side of Med Device

Apply Now (https://www.jobs.abbott/us/en)

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com (http://www.abbottbenefits.com/pages/candidate.aspx)

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 $97,300.00 - $194,700.00. In specific locations, the pay range may vary from the range posted.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com

Abbott

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