Regulatory Writer - Amazing company to work for - Remote working offered
- Employer
- Mosaic Regulatory Solutions
- Location
- Home Based / London
- Salary
- Flexible
- Start date
- 12 Jan 2022
- Closing date
- 11 Feb 2022
View more
- Discipline
- Regulatory Affairs, Regulatory Writing
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
Job Title: Regulatory Medical Writer
Reporting to: Director of Regulatory Strategy
Description:
The Regulatory Medical Writer will be responsible for the compilation and writing of documentation for regulatory submissions in accordance with appropriate ICH and GXP guidelines and requirements as well as company/client standards.
Responsibilities:
(In collaboration with Regulatory Consultants) produce regulatory documentation for submission to regulatory authorities in accordance with appropriate regulations, standards and guidelines (ICH and GXP) as well as company/client standards keeping to strict deadlines. Regulatory Documentation includes but is not limited to Module 2 overview documents; Briefing Books; protocols, clinical study reports.
Conduct Literature Searches to support Regulatory Applications
Edit and format regulatory documentation prepared by Regulatory Colleagues as appropriate
Collaborate with interdisciplinary teams, international client functions, vendors and Regulatory Affairs in the production of regulatory documentation
Ensure consistency, completeness, and adherence to agency guidelines, internal/client work instructions and SOPs throughout regulatory documentation
Prioritise multiple tasks in a fast-paced environment while keeping within regulatory timelines
Evaluate, contribute to and review SOPs, Guidelines and Work Instructions to ensure regulatory documentation are standardised and adhere to relevant guidelines
Operate as Subject Matter Expert in Regulatory Medical Writing with responsibility for training and mentoring fellow colleagues as appropriate
Stay current with industry practices and regulatory requirements that affect regulatory medical writing.
Provide companywide individual and group training on Regulatory Medical writing as appropriate
Core competencies:
Technical Competence:
Excellent written communication skills including extensive knowledge of English Grammar
A strong interest in Science and ability to communicate scientific or medical information in a clear and concise manner
Working knowledge of regulatory environment including thorough understanding of ICH, GXP and Global Regulatory Authority regulations and guidelines
Proficiency in Word, Excel, PowerPoint, email and the internet
Good organisational and time management skills
Ability to work under pressure to deadlines
Teamwork:
Work effectively to share responsibility as a team member.
Communication and Negotiation Skills:
Influence individuals or groups to reach consensus and achieve objectives.
Foster good interpersonal relationships.
Build trust and respect with peers and clients.
Strategic and Innovative Thinking:
The ability to think logically and understand complex ideas and data
Demonstrate ability to assess priorities and set strategies to align with/ meet business need.
Customer Focus:
Provide excellent project support to clients
Qualifications:
3+ years Medical Writing degree
Life science or pharmacy degree.
Full UK driving licence.
Company
Mosaic Regulatory Solutions is a specialist recruitment consultancy founded in 2002. Set up to meet the ever increasing demand for regulatory professionals in a market place with a growing skills gap.
Our expertise lies solely in regulatory affairs recruitment. And as such we have a real understanding of this sector. As this is our technical specialty we remain industry leading and preferred supplier of choice to a number of clients and first port of call for many regulatory affairs professionals.
We understand team / environmental “fit” is vital so continue to find the right career and environment to suit all candidates.
Listening to client needs, we respond with a professional, seamless and pro-active style of recruitment.
Mosaic work with an ever growing client base with the UK and Europe. We are dedicated to providing long term relationships with clients and candidates. We are proud that a high percentage of our business is repeat business.
- Website
- http://www.mosaicreg.co.uk/
- Telephone
- 07951 082482
- Location
-
Blackheath
London
SE3
GB
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