Regulatory Documentation Scientist

3 weeks ago

Hertfordshire, United Kingdom Reed Scientific Full time

**Regulatory Documentation Scientist**
**12 Month FTC**

**Hybrid working; in office as required**
- The first week will need to be in the office for training._

**Daily: £55.00 - £70.00ph LTD/Umbrella.**
**Hertfordshire area, UK**

REED Scientific are representing a global pharmaceutical company whose achievements help to transform the lives of millions of people. Their UK site is a key part of their global research and development programme.

**About the Job**
- 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 Roche 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

Ideally: 5 years experience
- 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.

The company is offering a competitive salary as well as a supportive and inclusive culture, with a strong focus on employee development. Plus, you will be part of an amazing team
If this looks of interest and you meet the requirements, don’t miss this opportunity

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