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 Manager, Medical Writing - China** available in Beijing. In this role, you will provide training to and supervise Medical Writers; review and provide feedback on the regulatory deliverables created by Medical Writers to support marketing applications and post-market surveillance filed with the China National Medical Products Administration (NMPA). The deliverables include the Clinical Evaluation Report (CER), Periodic Risk Evaluation Report (PRER), and other related regulatory documents for Vascular, Structure Heart, Cardiac Rhythm Management, Heart Failure, Neuromodulation, and Electrophysiology products. The Manager, Medical Writer works with the Clinical Evaluations Director, and interacts with Clinical Evaluation Project Managers to prioritize CER projects and create CER workloads for the writing team. **WHAT YOU’LL DO** + Supervises and manages a team of Medical Writers to deliver clinical evaluation documents to support product registration and approvals in China. + Ensures Medical Writers are adequately assigned to deliverables. Reviews and writes, if needed, clinical evaluation and other regulatory deliverables. + Provides guidance and training to Medical Writers and other personnel as needed on the clinical evaluation process, China NMPA regulations, NMPA guidance documents and on Abbott procedures, work instructions and templates related to clinical evaluation. + Interacts with the Clinical Evaluation Project Managers and China Regulatory Affairs to confirm regulatory strategy for, and timing of, submissions to China NMPA. May also interact with the Global business unit stakeholders to gain clarity on deliverables needed for CERs and other regulatory documents. + Collaborates in drafting new or in revising existing templates and procedures. + Engages proactively in the preparation of and presentation at the meetings with 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. + 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 6+ years of medical writing experience in the medical or pharmaceutical industry experience required; Experience may include writing experience in a medical, pharmaceutical, medical device, clinical research, medical or research industry , or combination of these skills + Experience as a manager with direct reports and/or oversight of project teams. + Proactive learner and self-motivated worker + Flexible to accommodate US working hours as needed + Must be able to effectively manage multiple projects and timelines **PREFERRED** : + Advanced degree(s) in biomedical, sciences, medicine, clinical/mechanical engineering, regulatory affairs, or related fields preferred + Contributor and/or review of CER content (CER writing experience strongly preferred) + Preference for management experience over CER activities + 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 (http://www.abbottbenefits.com/pages/candidate.aspx) 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. An Equal Opportunity Employer Abbot welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call 224-667-4913 or email corpjat@abbott.com