Qc Reviewer, Regulatory - Macclesfield, United Kingdom - Bioscript Group

Bioscript Group

Verified Company

Macclesfield, United Kingdom

3 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

Team, Respect, Ownership, Quality, Continuous Improvement

Do these values resonate with you? We could have the perfect role for you. Due to successful growth of our business, we are recruiting a QC Reviewer to join our Regulatory Writing Team.

Our QC Reviewers conduct quality control (QC) and other supportive activities to assist in the delivery of accurate, compliant, and submission-ready documents prepared by Document Authors.

Company Information

Bioscript Group delivers global healthcare communications to international pharmaceutical company clients across multiple therapy areas.

Established in 2005, Bioscript has developed an outstanding reputation as a high-quality strategic partner to its pharmaceutical clients, providing support with regulatory submissions, market access strategy, clinical publications, medical education and commercialisation.

We work collaboratively across functions and capabilities, sharing ideas and outputs to inform each other's work and to learn from each other's experience; providing many opportunities for personal and professional development

The Role

Perform QC review and manage QC projects in accordance with agreed timelines.
Verify internal consistency within a document and across related documents.
Verify uniformity and compliance of documents with internal or client standards (e.g., document templates, style guide, and publishing requirements).
Collaborate with Document Authors and other team members to resolve QC findings.
Support the Project Management team by monitoring the progress of all assigned projects against the agreed QC schedule and QC budget specification.
Proofread, edit, compile, and publish regulatory documents according to Bioscript/client conventions and applicable regulatory and industry guidance.

Requirements:

BSc (or equivalent) in biological or medical sciences, or proven relevant work experience in biological/medical sciences.
Experience in a QC Reviewer role for a range of regulatory writing deliverables (e.g. CSRs, Protocols, IBs, briefing documents).
Good working knowledge of Word, PowerPoint, Excel, and Adobe Acrobat.
Detailed understanding of editorial processes as applied to a range of deliverables.
Understanding of regulatory guidelines (e.g. ICH) and familiarity with all common regulatory deliverables.
Excellent written and verbal communication skills.

Why Bioscript?

We take pride and ownership in the quality of our work
We have a genuine focus on employee wellbeing
We offer a friendly, supportive and engaging environment in which individuals can thrive.

Bioscript is committed to promoting a diverse and inclusive community - a place where we can all be ourselves and succeed on merit