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Collaborate with clinicians, statisticians, clinical pharmacologists and other project team members to develop clinical study protocols and IBs to enable clinical studies and write CSRs when the clinical studies conclude. ? Collaborate with key project team stakeholders, develop clinical/regulatory documents in regulatory submission dossiers (IND, NDA/BLA, sNDA/sBLA) including CTD clinical summaries and clinical overviews. ? Prepare meeting preparation materials such as briefing documents to facilitate communication with regulatory agencies (e.g., CDE and US FDA). ? Work closely with project team leaders and function leads to develop resourcing strategies and implement new best practices in communication and submission development, and train and develop less experienced writers. ? Work with the MW&MS head to continuously improve the quality and efficiency of the medical writing group by training, optimizing and implementing SOPs/working instructions/templates, and improving project/time management and team communications skills. 任職要求： ? A bachelor’s degree in life sciences; an advanced degree in life sciences with 3 years or more experiences working as a regulatory/medical writer preferred. ? Ability to integrate information from all phases of drug development into cohesive clinical documents. ? Excellent oral and written communication skills. ? Experiences in developing processes and standards to ensure the quality and compliance of clinical documents. ? Experiences working with medical writing vendors/CROs ? Teamwork experiences and strong interpersonal skills in promoting teamwork and to ensure effective team communication; ability to develop others (coaching, mentoring) in medical writing ? Strong knowledge of drug development, GCP regulations, regulatory guidelines and reviewers’ expectations