Skip to main content

This job has expired

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.

Company info
Website
Telephone
07951 082482
Location
Blackheath
London
SE3
GB

Get job alerts

Create a job alert and receive personalised job recommendations straight to your inbox.

Create alert