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.
任职要求：
• 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