Senior Scientific Affairs Specialist Job
Job Description Job Attributes+
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Job ID
31096507
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Req #
ABLAUS31096507ENUSEXTERNAL
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Job Location
Alameda, CA, US
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Job Category
Medical and Clinical Affairs
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Job Type
Full time
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Travel
Yes, 10 % of the Time
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Schedule
40 hours per week
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 Alameda, California location with the New Medical Sensors group within Abbott Diabetes Care. Our New Medical Sensors business includes wearable sensors for monitoring numerous analytes in a healthcare setting.
We have an opportunity for a Senior Scientific Affairs Specialist. This position will work closely within the New Medical Sensors medical and clinical study team including the medical director, biostatistician, study management personnel, data management personnel, and other clinical study personnel. This position may also interact with executive leadership, physicians and regulatory authorities.
What You'll Work On
- Serve as an active member of study teams and provide scientific support to trial design and ongoing scientific analysis during protocol development. May include generation of pre-protocol documentation of scientific information.
- Support study-related documents which may include, but are not limited to, reports of prior investigational, investigational brochures, protocols, informed consent forms, and case report forms.
- Synthesize literature and competitive information for trial designs and results for assigned therapeutic area.
- Review and critically analyze statistical analysis plans.
- Review and critically analyze data sets.
- Facilitates communication between Sales and Marketing, R&D, Clinical, Regulatory Affairs, Quality, Risk Management, and Project Management.
- Support study level publication planning including manuscript writing and submission.
- Support publications for clinical study data through coordination with investigator authors and project management of reviews and revisions for abstracts and manuscripts.
- Generate documents to support regulatory submissions and/or respond to questions from regulatory authorities about existing submissions.
Required Qualifications
- Minimum qualification for this position is a Master’s degree in a relevant science or BA/BS with an equivalent combination of education and work experience.
- At least 3 years of relevant work experience (master’s degree); at least 5 years of relevant work experience (BA/BS).
- Experience conducting research in human subjects.
- This position requires strong data analysis and interpretation skills.
- This position will work in a highly matrixed and geographically diverse business environment.
- This position requires strong verbal and written communication skills and interpersonal skills.
- This position requires strong leadership skills as it may require interaction with executive leadership, physicians, and regulatory authorities.
- This position may require some travel (< 10%).
Preferred Qualifications
- Prior clinical research support in Medical Devices clinical trials, working in a regulated environment.
- Familiarity with one or more data analysis software (such as SAS, STATA, R) is highly desirable.
* 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/Abbottand on Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is $83,600.00 – $167,200.00. In specific locations, the pay range may vary from the range posted.
Job Skills
- clinical research
- regulatory affairs
- protocol development
- data analysis
- clinical trials
- data management
- statistical analysis
- data analysis software
- documentation
- stata
- project management
- sas
Additional Information
Who We Are
PUT YOUR TALENTS TO WORK
Abbott values the leadership skills developed through military service and we have a broad range of functional areas to put your talents to work. Our organization is making a difference in the lives of the people we serve with a diverse offering of healthcare products. We have a strong veteran employee community to help with your transition from the military to the corporate world.