To author and review high quality clinical and safety documents: non-registration clinical Study Reports (CSR), Development safety Update Reports (DSUR), Risk Management Plans (RMP). Core member of clinical Trial Team/participate in safety Management Team.
Actively participate in planning of data analyses and presentation used in CSRs.
Act as documentation consultant in CTTs and SMTs to ensure compliance of documentation to internal company standards and external regulatory guidelines.
May Act as Program Writer ensuring adequate medical writing resources are available for assigned Program and consistency between documents.
Qualifications
Minimum university life science degree or equivalent is required. Advanced degree or equivalent education/degree in life sciences/healthcare is desirable.
≥ 2 years medical writing experience or other relevant pharma industry experience combined with scientific and regulatory knowledge, plus strong knowledge of the medical writing processes.
Good knowledge of and some experience in global regulatory environment and process (key regulatory bodies, key documents, approval processes, safety reporting requirements).
Knowledge of process for and some experience in global registering of drugs (simple submissions).
Excellent communication skills (written, verbal, presentations). Very good understanding of biostatistics principles.
