Job Description ? Senior Regulatory Documentation Scientist
12 Months, Outside IR35
Senior Regulatory Documentation Scientist
Global Product Development/ Regulatory Documentation
To prepare regulatory documents for submission to regulatory authorities within subject area (clinical/safety). Working with minimal guidance, the Senior Regulatory Documentation Scientist takes accountability for delivering regulatory documents, working effectively and closely with key content owners in the relevant functions. The Senior Regulatory Documentation Scientist applies scientific writing, document and project management expertise and contributes to the functional excellence of regulatory documentation through process management.
Major Responsibilities and Accountabilities:
- Manages the preparation of a suite of regulatory documents e.g. Clinical Dossier, suite of Safety Documents
- Leads Writing/Editing Team for preparation of Clinical Dossiers/Safety Reports
- Reviews documents to ensure compliance with documentation quality standards, regulatory requirements and consistency of messages across all documents for a product/ within a clinical dossier
- Prepares specifications for outsourced work (writing/review of documents) and serves as liaison for project purposes
- Plans and creates timelines for the production of assigned documents e.g. Clinical Dossier/Suite of Safety documents. Ensures proper planning and resourcing of all documents assigned to Writing/Editing Team including work to be outsourced
- Actively contributes to best practices and continuous improvement within Regulatory Documentation. Represents the group in functional and cross functional initiatives/projects when required
- Acts as a mentor to new members/less experienced members of the Documentation group
- In addition, assumes the responsibilities of a Regulatory Documentation Scientist
Global Reporting Line
Functional/Senior Functional Manager
Professional and Technical Requirements
Bachelor?s degree or equivalent.
Advanced degree in life sciences or other relevant field preferred.
Experience, Knowledge, Skills
- Demonstrated clear, high-quality scientific writing style in the English language
- Experience in regulatory affairs or related functions in drug development, knowledge of international regulations, and previous experience of authoring and/or editing regulatory documentation.
- Aptitude or proven ability to guide the work of others
- Ability to independently analyze and synthesize data from a broad range of disciplines
- Project management skills: consistently achieves multiple tasks and goals on-time
- Strong interpersonal and verbal communication skills
- Influencing skills: can influence without authority.
- Ability to work effectively in a team environment, establishes strong collaborative relationships, resolves conflict by creating an atmosphere of openness and trust
- Thinks through problems clearly and logically
- Agency: Achieva Group Limited
- Reference: BH-33848
Website: Achieva Group Limited
- Posted: 21st September 2022
- Expires: 19th October 2022