Job Descriptions

The Senior English Writer is responsible for providing functional area leadership in English Writing for ensuring consistent processes and excellence in providing planning and delivery of writing support and/or translation for high quality submission-ready documents, clinical study reports, narratives, regulatory documents, media releases and professional business letters/emails. Works independently and collaboratively in producing appropriate quality level of both English and Chinese documents as per requested under guidance of strategic development team and/or cross functional team. Interfaces with external groups (e.g. KOL, CRO, PI, Regulatory, Medical, Clinical, Publishing, Business Partners) and internal groups (functional heads) to ensure accurate and timely completion/delivery of strategically critical information.

Key Responsibilities

• Serves as English Writing lead to implement translation of submission-ready clinical documents, regulatory paper, media releases and business communications.
• Ensures all translational documents are audience oriented, professional, and based on English language logic/rhetoric.
• Performs literature searches as needed for drafting document content and interprets literature information for recommendation and basis of leadership decisions.
• Knowledgeable of US and international regulations, requirements and guidance associated with clinical regulatory document preparation and submissions. Learns and applies knowledge of pharmaceutical products to scientific and PR publishing projects.
• Must continually train and be compliant with all current industry requirements pertinent to clinical regulatory submissions under guidance of CMO and/or consultant.
• Serves as department representative on cross functional teams and/or external conferences.

Qualifications and Requirements

• Demonstrated ability to ensure excellent translation of professional/specialty Chinese documents to English documents.
• Demonstrated ability to think and write logically in accordance with both Eastern and Western language/culture.
• Experiences in high quality professional translation and production of bilingual documents.
• Must have a minimum of at least 5-year experiences either studying or working in oversea organizations.
• 3 years relevant industry experience in translation/writing in the healthcare or a related area.
• Minimum of a B.S. degree in English, Life Sciences, Clinical, Medical or related field.
• Excellent communication skills (written, verbal, presentations).
• Superior attention to detail. Ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity and accuracy.

Preferred Additional Experience

• Experiences in clinical development and business experience in order to have a thorough understanding of the processes including translational, professional or medical writing.

上班地址：上海市张江高科技园区牛顿路421号