Job Description

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

Job Location: Shanghai, or homebased

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

·Provide support to other medical and regulatory writers to ensure delivery of documents according to timelines and within budget and to acceptable quality standards

·Support business development in project bids and new business proposals

·Mentor and/or supervise Medical and Regulatory Writers and Quality Reviewers as required

·Train other Medical and Regulatory Writers and Quality Reviewers as required

·Support Regulatory Strategic Development team efforts on medical and Regulatory Writing projects

·Act as the primary client contact for medical writing projects

·Participate in client meetings and other project-related meetings and teleconferences as needed

·Any other activities related to the position as required by direct supervisor

·Write scientific papers, meeting abstracts, and other medical and/or scientific documents, as necessary

Supervisory Responsibilities:

·Manages and coaches directly a team of MW I/II and Senior Medical Writers, with clear goal settings and performance review

·Provides work direction and oversight to team’s daily work

·Tracks and plans resource allocation and utilizations.

Job Requirements:

• Education
  • A university degree in the field of Life Sciences, Medicine or related field; Graduate/postgraduate degree highly preferred

• Experience
  • At least 4years of relevant Medical and Regulatory writing experience in the pharmaceutical industry, CRO, or consultancy experience a plus
  • Proven track record in preparing clinical and regulatory documents with minimum supervision according to budget and timelines
  • Experience in managing medical and regulatory writing projects
  • People management experience is a plus

• Skills/Competencies
  • Strong leadership skills
  • Strong scientific writing skill in Chinese
  • Strong computer skills, including Microsoft Office
  • Proficiency in medical terminology
  • Ability to manage large and complex medical and regulatory writing projects
  • In-depth knowledge of local and international guidance and regulations relevant to medical and regulatory writing
  • Ability to exercise judgment within defined procedures and practices and to determine appropriate action independently
  • Excellent attention to detail
  • Superior problem-solving skills
  • Strong interpersonal and communication skills
  • Ability to forge and maintain client relationships
  • Ability to perform client-facing tasks
  • Strong written and verbal communication skills in English is a plus

·Capabilities

• Ability to work in a digital environment using computer systems
• Ability to work within a team
• Ability to manage a team
• Ability to work on the MW KPIs and resource planning
• Ability to travel, if needed