国产一区二区免费,翔田千里AV,无码电影,红杏亚洲影院一区二区三区,国产精品欧美激情

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