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Maidenhead, England, United Kingdom
Hybrid
About This Role:
As a PV Scientist Quality Document Manager, you will play a pivotal role in ensuring that all documents authored by the Safety Surveillance and Aggregate reports (SSA) team, or by vendors overseen by SSA, adhere to the highest quality standards set by Biogen. You will be responsible for managing the quality of these documents, ensuring they are suitable for their intended audience. This position involves a critical eye for detail, where you will verify data accuracy, ensure stylistic consistency, and maintain compliance with Biogen's style guide. Your contributions will be key in maintaining the integrity and reliability of SSA documentation, supporting the overarching mission of Biogen to deliver safe and effective pharmaceutical solutions. By collaborating with internal and external stakeholders, you will uphold the quality of our pharmacovigilance efforts and drive improvements in our quality documentation processes.
This is a hybrid role requiring 50% weekly office attendance in Maidenhead.
What You’ll Do:
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.
Who You Are:
You are an individual with a keen eye for detail and a passion for maintaining high-quality standards. You thrive in a collaborative environment and are adept at working with various stakeholders to achieve common goals. Your strong organizational skills and ability to prioritize tasks independently make you an asset to any team. You are comfortable with medical terminology and can clearly present scientific and medical data, both verbally and in writing. Your English writing skills are exceptional. Your experience in pharmacovigilance and familiarity with drug development processes enhance your ability to contribute effectively to the team.
Required Skills:
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).
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about Biogen.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
