Principal Medical Writer

Santa Clara, CA, United States

Principal Medical Writer

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. You’ll also have access to:

Career development with an international company where you can grow the career you dream of.

Free medical coverage for employees* via the Health Investment Plan (HIP) PPO

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 bachelor’s 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.

The Opportunity

This position works out of our Santa Clara, CA., location, and can also be based in the Minneapolis/St Paul area, in the Structural Heart (SH) Division. Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease.

We have an exciting opportunity for the right candidate to join our rapidly growing clinical team within the SH division. The Principal Medical Writer will be responsible for producing podium presentations, scientific publications, and clinical study reports for global regulatory submission using clinical data sets. The work will directly support evidence generation for transcatheter aortic valve implantation (TAVI) program. This position will work collaboratively with clinical scientists, biostatisticians, marketing, and other cross-functional leads. This position will also play a supporting role in interacting with clinical trial investigators to ensure the successful execution of clinical strategies to meet corporate podium and publication goals.

What You'll Work On

This position will work closely with cross-functional stakeholders in marketing, medical affairs, clinical affairs, biometrics, project management, data management, and other clinical groups. This position will also interact with physicians and regulatory authorities. Furthermore, this position will be required to execute the job responsibilities within the corporate policies and standard operating procedures. This position will:

Responsible and accountable for execution of podium presentations, scientific publications, clinical study report writing for regulatory submission in collaboration with clinical program director and scientists

Ensure cross-functional alignment of prioritization of clinical evidence dissemination

Effectively communicate information through the planning and execution of meetings and presentations and present recommendations to all stakeholders

Ensure internal stakeholders are up to date on all activities supporting podium presentations (conference acceptances, presentation status) and publications status as well as clinical study report review

Drive internal and external collaborators to meet submission deadlines for conferences and journal submissions

Drive activities to meet the deadlines for internal approvals of clinical study reports for regulatory submissions

Oversee responses to journal reviewers and ensure they are handled in a timely manner

Ensure all data presented is cohesive and in alignment with Abbott standards

Support publication committee activities (planning and strategy) for key trials

Plays a key role in KOL management through strategic engagement while maintaining a collaborative relationship

Develops and maintains current, in-depth, relevant functional knowledge (such as scientific and technical aspects) of projects in support of the business on a global basis

Will perform this job in a quality system environment.

Prioritization across teams to ensure strategic goals/milestones within Clinical Affairs are met

Works with stakeholders to define business questions, requirements, timelines, objectives, and success criteria to address the need

Required Qualifications

Bachelor's degree required; advanced degree preferred; degree in science, medicine, or a similar discipline is highly preferred.

Minimum of 8+ years of related work experience in clinical trials/medical writing

Cardiovascular and structural heart knowledge is a plus.

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

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 X @AbbottNews.

The base pay for this position is $109,300.00 – $218,500.00. In specific locations, the pay range may vary from the range posted.

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