Senior Medical Writer
Senior Medical Writer
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Job Description
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 113000 colleagues serve people in more than 160 countries.
For years Abbotts medical device businesses have offered technologies that are faster more effective and less invasive. Whether its 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 10000 people have healthier hearts improve quality of life for thousands of people living with chronic pain and movement disorders and liberate more than 500000 people with diabetes from routine ngersticks.
We currently have an exciting opportunity for a Senior Medical Writer Clinical Evaluation - China available 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 YOULL 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 guidances (ISO13485 ISO14155 ISO14791 China NMPA regulations NMPA guidance IMDRF guidance etc.) and applicable Abbott SOPs and DOPs.
EDUCATION AND EXPERIENCE YOULL BRING
:
- Full professional working proficiency in both English and Standard Chinese/Mandarin
- Bachelors 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:
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 on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is
N/AIn 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
Required Experience:
Senior IC
Employment Type
Full-Time
