Key Accountabilities
Write documents for submission to FDA, including but not limited to: independent review charters, acquisition guidelines, reviewer training manuals, protocols, Case Report Forms (CRFs), and other documents required by Perceptive SOPs.
Write any of the clinical documents associated with drug or device applications to regulatory bodies. Write documents associated with clinical trials, which are not necessarily part of regulatory submissions, including but not limited to: study manuals, CRF completion instructions, articles and manuscripts
Coordinate and conduct interdivisional team review and document deliverables according to Perceptive guidelines/SOPs, including distributing drafts, chairing round table meetings, incorporating revisions, and completing the sign-off procedures.
Perform quality control review such as copy editing, content editing, and number checking for other writers as required.
Perform literature searches/reviews and research current guidelines as necessary to gather background information and training for development of documents.
Review analysis plans to assist in determination of appropriateness of content/format for clinical writing.
Attend internal technical team and client team meetings as required.

Serve as Medical Writing representative on assigned Project teams.
Regularly communicate project related issues with the Associate Director Medical Writing and the project team, as appropriate.
Assemble client deliverables to be filed appropriately in Central Files and project archives.
Adhere to ICH, FDA or other appropriate regulatory body guidelines with respect to document content and style, and compliance with departmental guidelines and corporate SOPs.
Meet client expectations by following any templates, styleguides, or SOPs provided by the client for document development (within the appropriate regulatory guidelines).
Keep abreast of professional information and technology through workshops and conferences.
May assist in development of formats, templates, and general guidelines for clinical documentation and workflow procedures.
May participate in departmental or interdivisional process improvement and training initiatives.
May provide guidance to junior staff members.

Skills
Excellent written and oral communication and interpersonal skills, and knowledge of the drug development process essential; strong word processing skills, familiarity with Microsoft Word for Windows.

Education
Bachelor's degree in Life Sciences/Health Related Sciences (minimum)

Language Skills
Fluent in English

上班地址：朝外大街乙12 號昆泰國際大廈11樓1115室