Back to job search

Associate Regulatory Writer Graduate

SRG • Contract • Remote (London, London, GB) • 1d ago

Job Title: Associate Regulatory Writer Graduate

Location: White City, London

Contract: 12 Months / Hybrid 3 days onsite

Hours: 37.5 per week

Rates: £31,050 p/a

Job Description

SRG are looking for an associate regulatory writer to join a leading pharmaceutical company based in London. The main purpose of this role is to write and/or edit under guidance high quality clinical and safety documentation.

Duties and Responsibilities

To write and/or edit under guidance high quality clinical and safety documents: Clinical Study Protocols (CSP) and protocol amendments, non-registration Clinical Study Reports (CSR), Development Safety Update Reports (DSUR), Clinical Trial Registration Documents.
May coordinate outsourced activities in
Main sub-team representative at the Clinical Trial Team (CTT).
Participate in planning of data analyses and presentation used in
May act as documentation consultant in CTTs to ensure compliance of documentation to internal company standards and external regulatory guidelines.
May act as liaison between CTTs and publishing teams to ensure timely delivery of final documents for publishing.
May contribute to development of processes within
Maintain audit, SOP and training

Experience and Qualifications

Education:

(minimum/desirable)

Minimum university life science degree or equivalent is required. Advanced degree or equivalent education/degree in life sciences/healthcare is desirable.

Languages:

Fluent English (oral and written).

Experience / Professional Requirement:

· Some medical writing experience or other relevant pharma industry experience combined with scientific and regulatory knowledge.

· Understanding of global regulatory environment and process (key regulatory bodies, key documents, approval processes, safety reporting requirements).

· Excellent communication skills (written, verbal, presentations)

· Understanding of biostatistics principles.

· Ability to prioritize and manage multiple demands and projects.

· Ability to define and solve complex problems ("Problem- solver")

· Broad knowledge and future oriented perspective

· Understanding of matrix environment

· Global, cross-cultural perspective and customer orientation.

Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.

SRG

Apply for this job

Share this opportunity

Graduate job seekers also viewed these roles

Junior Commercial Analyst

Hearst UK • Full-time • London, Greater London, England, United Kingdom • 8h ago

Media, Publishing, & Journalism Commercial Commercial Analyst

8h ago

Apply

Social Executive (Entertainment)

Hearst UK • Full-time • London, Greater London, England, United Kingdom • 8h ago

Media, Publishing, & Journalism Social Media Entertainment

8h ago

Apply

Executive Assistant

LADbible Group • Full-time • London, Greater London, England, United Kingdom • 8h ago

Media, Publishing, & Journalism Executive Assistant

8h ago

Apply

REGISTER YOUR INTEREST: Creative Opportunities

LADbible Group • Full-time • London, Greater London, England, United Kingdom • 8h ago

Media, Publishing, & Journalism Creative Arts & Design Creative Jobs

8h ago

Apply

London Legal Training Contract

Slaughter & May • Contract • London, Greater London, England, United Kingdom • 1d ago

Law Graduate Opportunity Law Graduate Graduate Job Training Contract

1d ago

Apply

London Trainee Contract

Morgan, Lewis, & Bockius LLP • Contract • London, Greater London, England, United Kingdom • 1d ago

Law Graduate Opportunity Law Graduate Graduate Job Training Contract

1d ago

Apply

Retail Apprentice Travel Advisor, Orpington

TUI Group • Full-time • Orpington, Greater London, England, United Kingdom • from £8.05 / hour • 2d ago

Hospitality, Travel, & Tourism Apprenticeship Travel School Leaver Opportunity No Degree Required

2d ago

Apply

Front Office Graduate

The Landmark London • Full-time • London, Greater London, England, United Kingdom • £25,500 - £29,000 / year • 3d ago

Hospitality, Travel, & Tourism Customer Service Hospitality Graduate Opportunity Graduate Job

3d ago

Apply

Wardrobe Assistant

ATG Entertainment • Full-time • London, Greater London, England, United Kingdom • 5d ago

Creative Arts & Design School Leaver Opportunity Arts No Degree Required Arts Jobs

5d ago

Apply

Technology Support Internship

The Walt Disney Company • Full-time • London, Greater London, England, United Kingdom • 5d ago

Creative Arts & Design Technology Internship University Student Opportunity Computer Science

5d ago

Apply