Senior Project Manager, Clinical Evaluation - China (on-site)
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Locations: United States - California - Santa Clara
Time Type: Full time
Posted on: Posted 30+ Days Ago
Job Requisition ID: 31095672
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.
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. 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.
- 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.
For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Our medical device technologies are designed to help people live their lives better and healthier.
The Opportunity
We currently have an exciting opportunity for a Senior Project Manager, Clinical Evaluation - China available on-site in Santa Clara, CA. In this role, you will provide project management, regulatory strategies, and medical writing expertise to support marketing applications and post-market surveillance filed with China National Medical Products Administration (NMPA). Your deliverables include Clinical Evaluation Report (CER), Periodic Risk Evaluation Report (PRER), and other related regulatory documents. Daily activities are related to managing cross-functional teams and authoring the regulatory deliverables for Vascular, Structure Heart, Cardiac Rhythm Management, Heart Failure, Neuromodulation, and Electrophysiology products.
What You’ll Work On
- Facilitate bilingual communication with cross-functional teams in both English and Standard Chinese/Mandarin.
- Acquire and implement expertise in clinical evaluation and up-to-date China NMPA regulations.
- Strategize and deliberate on clinical data/evaluation-related regulatory strategies.
- Communicate with external medical writing vendors on project strategy and timelines.
- Develop regulatory deliverables (CER, PRER, etc.) with support from external medical writing vendors.
- Ensure regulatory deliverables are completed on-time and within budget.
- Engage proactively in drafting responses during China NMPA’s review processes.
- Provide regular project status updates to management teams.
- Manage competing and/or shifting priorities.
- Contribute to process improvement efforts.
Required Qualifications
- Bachelor’s Degree in related field or an equivalent combination of education or work experience.
- Minimum 6 years related work experience with a strong understanding of specified functional area.
- Solid understanding and application of business concepts, procedures, and practices.
- Ability to work in a quality system environment.
- Ability to analyze diverse scope problems and exercise judgment within defined practices.
Preferred Qualifications
- Bachelor’s Degree in Life Sciences; Advanced degree(s) in relevant fields.
- Full professional working proficiency in both English and Standard Chinese/Mandarin.
- Relevant working experience in clinical evaluation, project management, or related experience.
- Working knowledge on relevant regulations and guidance.
- Excellent written, verbal, and presentation skills.
- Demonstrated ability to identify and adapt to shifting priorities.
- High attention to detail with excellent organizational skills.
Apply Now
* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan.
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.
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 FAMILY:
Regulatory Operations
DIVISION:
MD Medical Devices
LOCATION:
United States > Santa Clara: Building B - SC
WORK SHIFT:
Standard
TRAVEL:
Yes, 5% of the Time
MEDICAL SURVEILLANCE:
No
SIGNIFICANT WORK ACTIVITIES:
Awkward/forceful/repetitive (arms above shoulder), Continuous sitting for prolonged periods.
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
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