Job Title: Regulatory Writer
This is a high-profile role that involves creating, reviewing and managing the production of top-notch clinical and safety documentation for submission to regulatory authorities in support of marketing applications.
The successful candidate will be responsible for crafting and reviewing high-quality clinical and safety documents including non-registration Clinical Study Reports (CSRs), Development Safety Update Reports (DSURs) and Risk Management Plans (RMPs).
Key Responsibilities:
* Create and review high-quality clinical and safety documents
* Lead outsourced Narrative projects
* Coordinate other outsourced activities in RWS
* 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
Requirements:
* Excellent communication skills (written, verbal, presentations)
* Very good understanding of biostatistics principles
* Ability to prioritize and manage multiple demands and projects
* Ability to define and solve complex problems
* Proven track record in matrix environment
* Experience in contributing to global, cross-functional projects
Education and Experience:
* Minimum university life science degree or equivalent is required
* Advanced degree or equivalent education/degree in life sciences/healthcare is desirable
* Medical writing experience or other relevant pharma industry experience combined with scientific and regulatory knowledge, plus strong knowledge of the medical writing processes