Senior QC Specialist

This is a fully remote position, open to applicants in Germany.

📋 Description

• Act as an independent QC Specialist on any QC project.

• Verify that all numerical data in text, tables, and statements derived from data are accurate by consulting the source tables, figures, or listings.

• Ensure compliance with the required style guide for consistency in hyphenation, capitalization, reference formatting, Word styles, and more.

• Review text to confirm it is well-structured, logically organized, and consistent with the supporting data.

• Validate facts and raise any queries with the author.

• Ensure tables, figures, and captions are accurate.

• Provide support to other QC Specialists and/or cover absences on any project.

• Assist other medical writers with straightforward writing tasks and other activities involved in document preparation (e.g., creating a List of Abbreviations, populating tables with data, or verifying literature references).

• For projects where they serve as the Lead QC Specialist, monitor QC timelines.

• Attend client meetings as necessary to coordinate and proactively manage client QC activities.

• Supervise and mentor Associate QC Specialists.

• Act as a Client QC Manager for a specific client.

⛳️ Requirements

• At least 3 years of relevant experience as a QC Specialist in a clinical regulatory environment.

• A scientific qualification (BA, BSc, MA, MSc, PhD, or equivalent).

• Proficient written and spoken English skills.

• Conducted QC activities on a minimum of 5 different key regulatory documents (e.g., CSR, CSP, Module 2.7 summary for CTD).

• Demonstrated ability to accurately identify scientific text through a QC assessment.

• Appreciation for well-written documents and a keen eye for detail.

• Possess a skillset to actively engage in a team with diverse personalities (i.e., strong interpersonal skills).

• Advanced proficiency in MS Office applications (i.e., Word and Excel) and Adobe.

• Capability to manage all phases of the QC process for complex documents.

• Responsible for all interactions with Lead Writers without the assistance of another QC Specialist.

• Oversee and coordinate other QC Specialists supporting them as the Lead QC Specialist on a complex QC project.

• Recognize when to seek assistance from other QC Specialists to meet deadlines, if necessary.

• A positive demeanor with the ability to work under pressure, find practical solutions to challenges, and maintain oversight of QC activities throughout a complex project.

🏝️ Benefits

• Competitive base salary based on experience level and the company's compensation policies.

• Annual bonus based on both company and individual performance.

• A generous allowance of paid time off (vacation, holidays, birthday, illness).

• Additional country-specific benefits.

• Complimentary weekly yoga sessions.

• Various fun and engaging events to promote team bonding and development.