JOB DESCRIPTION:

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 113,000 colleagues serve people in more than 160 countries.

For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s 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 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.

We currently have an exciting opportunity for a Senior Medical Writer, Clinical Evaluation - China available in Beijing. In this role, you will provide medical writing expertise to support marketing applications and post-market surveillance filed with the China National Medical Products Administration (NMPA). Your deliverables include the Clinical Evaluation Report (CER), Periodic Risk Evaluation Report (PRER), and other related regulatory documents. Daily activities are related to authoring CER, PRER and related regulatory documents for Vascular, Structure Heart, Cardiac Rhythm Management, Heart Failure, Neuromodulation, and Electrophysiology products.

WHAT YOU’LL DO  

• Writes and contributes to the CERs, PRERs, Regulatory Responses and other related documentation.  
• Evaluates and summarizes clinical evidence including data from sources such as clinical investigations, literature, post-market surveillance, risk management, and post market clinical evaluations.  Analyzes results in preparation for product applications and submissions to China NMPA.   
• Effectively communicates in both English and Standard Chinese/Mandarin and collaborates with team members and stakeholders, in completing clinical evaluation project related deliverables.
• Supports additional clinical, regulatory and related deliverables as assigned.
• Engage proactively in the preparation of and presentation at the meetings with China NMPA.
• Ensures quality in all deliverables and documentation with attention to detail, consistency and integrity of data. 
• 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.
• Ensures compliance to applicable regulations and guidance’s (ISO13485, ISO14155, ISO14791, China NMPA regulations, NMPA guidance, IMDRF guidance, etc.) and applicable Abbott SOPs and DOPs.

EDUCATION AND EXPERIENCE YOU’LL BRING  

REQUIRED:

• Full professional working proficiency in both English and Standard Chinese/Mandarin
• Bachelor’s  Degree with 4+ years of medical writing experience in the medical or pharmaceutical industry or 7+ years general technical writing experience required
• Experience may include writing experience in a medical, pharmaceutical, medical device, clinical research, medical or research industry , or combination of these skills
• Excellent written and verbal communication skills
• Strong commitment to meeting timelines
• Proactive learner and self-motivated worker
• Flexible to accommodate US working hours as needed
• Willingness to take ownership

PREFERRED:

• Advanced degree(s) in biomedical, sciences, medicine, clinical/mechanical engineering, regulatory affairs, or related fields preferred
• CER writing experience preferred
• Experience with collaborative, cross-functional teams
• Excellent analytical skills and ability to manage complex tasks and manage time effectively
• Proficient with Microsoft Office 365  

WHAT WE OFFER  

At Abbott, you can have a good job that can grow into a great career. We offer: 

• Training and career development, with onboarding programs for new employees and tuition assistance  
• Financial security through competitive compensation, incentives and retirement plans  
• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs 
• Paid time off  
• 401(k) retirement savings with a generous company match 
• The stability of a company with a record of strong financial performance and history of being actively involved in local communities 

Learn more about our benefits that add real value to your life to help you live fully:  www.abbottbenefits.com  

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. 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 and @AbbottGlobal. 

     

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Clinical Affairs / Statistics

     

DIVISION:

MD Medical Devices

        

LOCATION:

China > Beijing : 27 Dong San Huan Bei Lu

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Not specified

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable