任职资格:
Minimum Job Requirements
·Master degree or above in medical or pharmaceutical area. Experience and knowledge in anti-infectious area or digestive tract disease are preferred.
·Not less than 5 years’ medical writing experience in pharmaceutical companies.
·Mindset of regulatory submission.
·Good communication skill
·Good command of English in listening, reading and writing.
Essential Physical Requirements
·Ability to operate a computer keyboard and telephone.
·Ability to sit for extended periods of time – up to 4 hours at a time.
主要岗位职责:
Compiles, writes, and edits medical writing deliverables, and serves as medical writer within and across departments with moderate supervision.
Develops or supports, a variety of documents that include but not limited to:
CTD dossier and documents to support pre-IND, pre-NDA, IND and NDA for China authority in clinical and non-clinical parts.
Clinical study design, including investigation on competitors trial design and new protocol design(registration class 1,2 and class 5.1).
Clinical study protocols and clinical study protocol amendments;
Clinical study reports; Lead discussion on the issues in CSR between stakeholders.
Patient narratives;
Investigator brochures.
Reviews statistical analysis plans and table/figure/listing specifications for appropriate content and for grammar, format, and consistency. Provides feedback to further define statistical output required.
Interacts with department head and staff members in data management, biostatistics, and medical as necessary to produce writing deliverables.
Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, CDE regulation/guidelines as well as Company Standard Operating Procedures, approved templates when completing medical writing projects, on-time.
Performs on-line clinical literature searches, as applicable.
Continues professional development to keep pace with regulatory guidance affect medical writing and to improve skills.
Completes required administrated tasks within the specified timeframes.