Associate Manager Medical & Regulatory Writing

Job Description:

The Associate Manager Medical & Regulatory Writing (China) works independently to prepare anddeliverclinicalandregulatorydocumentsforawiderangeoftherapeuticareas,performing the tasks listed below.

Job Duties and Responsibilities:

·Manage and coach directly a team of less experienced members of the Medical & Regulatory Writing

·Create, monitor, and maintain timelines for medical and regulatory writing projects

·Lead the authoring of clinical and regulatory documents, e.g., clinical study reports, protocols and amendments, investigator brochures, clinical and non-clinical summary documents, etc.

·Coordinate overall quality review of documents

·Manage large and complex medical and regulatory writing projects which may include supervision of other medical writers and quality reviewers to ensure delivery of documents according to timelines and within budget and to acceptable quality standards

·Provi...