At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at .
As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
Medical Affairs GroupJob Sub Function:
Medical WritingJob Category:
ProfessionalAll Job Posting Locations:
Beijing ChinaJob Description:
Lead and independently deliver complex CERs and related clinical evaluation documents.
Develop and execute literature search strategies; conduct evidence synthesis equivalence assessment and risk analyses; and generate highquality clinical sections.
Independently draft additional medical writing deliverables as assigned.
Collaborate closely with RA Clinical and R&D teams to ensure timely achievement of project milestones.
Support the preparation of regulatory responses and documentation for regulatory agency interactions.
Contribute to the enhancement of SOPs templates and associated documentation standards and assist in their implementation.
Adhere to SOPs and documentation workflows to ensure timely complete and highquality project delivery.
Provide guidance and oversight to specialists and new team members as needed.
Required Skills:
Preferred Skills:
Business Writing Clinical Research and Regulations Clinical Trials Operations Coaching Collaborating Communication Copy Editing Data Synthesis Industry Analysis Medical Affairs Medical Communications Problem Solving Process Oriented Proofreading Quality Standards Research Ethics Standard Operating Procedure (SOP)Required Experience:
Manager
About Johnson & Johnson A t Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s larges ... View more