PV Quality Document Lead: Scientific Editing & Compliance

Biopharma Careers; Maidenhead; Hybrid; GBP 55,000 - 75,000; Full time

Job summary

Biogen in Maidenhead, United Kingdom, is seeking a PV Scientist Quality Document Manager to ensure SSA documents meet the highest quality standards and Biogen style guidelines. You will verify data accuracy, maintain consistency, and collaborate with stakeholders to uphold pharmacovigilance documentation integrity.

The role is hybrid with 50% office attendance in Maidenhead, and involves leading reviews, developing templates, and driving process improvements in quality documentation within a

Qualifications

• Bachelor’s degree in biologic or natural science, or healthcare discipline.
• Previous experience in pharmacovigilance, medical writing, scientific editing and/or publishing.
• Significant years of writing and editing experience, preferably in the pharmaceutical or biotech industry.
• Comfortable with medical terminology.
• Familiarity with pharmacovigilance and drug development, including knowledge of clinical trial safety regulations and post-marketing safety regulations.
• Ability to interpret, analyze, and present scientific and medical data.
• Strong organizational skills and ability to prioritize independently.
• In depth knowledge of common data processing software (e.g., Excel, PowerPoint, Microsoft Word, Business Objects).

Responsibilities

• Perform source data verification to ensure consistency with source documents.
• Conduct editorial, technical, and scientific reviews for grammatical and stylistic accuracy.
• Identify document findings and collaborate with authors to address issues.
• Review and oversee vendor work, providing necessary guidance.
• Collaborate with the Senior PV Scientist Quality Document Manager on quality metrics and QC planning.
• Maintain and update SSA QC checklists as needed.
• Document issues with format, linking, and cross-referencing for quality oversight.
• Present quality trends in team meetings and discuss standards.
• Create and maintain SSA document templates.
• Drive process improvement initiatives for quality documentation.
• Perform administrative tasks and communicate results to stakeholders.

Skills

Pharmacovigilance

Medical writing

Scientific editing

Medical terminology

Data interpretation

Organization

Education

Bachelor’s degree in biologic or natural science

Tools

Excel

PowerPoint

Microsoft Word

Business Objects

Job description

Biogen in Maidenhead, United Kingdom, is seeking a PV Scientist Quality Document Manager to ensure SSA documents meet the highest quality standards and Biogen style guidelines. You will verify data accuracy, maintain consistency, and collaborate with stakeholders to uphold pharmacovigilance documentation integrity.

The role is hybrid with 50% office attendance in Maidenhead, and involves leading reviews, developing templates, and driving process improvements in quality documentation within a