Associate Manager Medical and Regulatory Writing

2 weeks ago

Shanghai, Shanghai, China Caidya Full time

Job Overview:

The Senior Medical and Regulatory Writer works independently to prepare and deliver clinical and regulatory documents for a wide range of therapeutic areas, performing the tasks listed below.

Job Duties and Responsibilities:

Write, edit, format, compile and review assigned documents requested by internal cross-functional teams and/or clients Create, monitor and maintain timelines for medical and regulatory writing projects Prepare 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 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 May provide oversight to less experienced members of the Medical and Regulatory Writing team

Supervisory Responsibilities:

No supervisory responsibilities.

Job Requirements:

Education A university degree in the field of Life Sciences, Medicine or related field; Graduate/postgraduate degree highly preferred Experience At least 5 years of relevant Medical and Regulatory writing experience in the Pharmaceutical industry, CRO experience a plusProven track record in preparing clinical and regulatory documents with minimum supervision Skills/Competencies Strong written and verbal communication skills in EnglishStrong computer skills, including Microsoft OfficeProficiency in medical terminologyAbility to manage large and complex medical and regulatory writing projectsIn-depth knowledge of local and international guidance and regulations relevant to medical and regulatory writingAbility to exercise judgment within defined procedures and practices and to determine appropriate action independentlyExcellent attention to detailSuperior problem-solving skillsStrong interpersonal skillsAbility to perform client-facing tasks Capabilities Ability to work in a digital environment using computer systemsAbility to work within a teamAbility to manage a teamAbility to work on global projects in a multi-cultural environmentAbility to travel, if needed

The company will not accept unsolicited resumes from third party vendors.

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