Senior QC Specialist

Senior QC Specialist (f/m/d) (Germany, UK, Portugal, Italy, Ireland) 

Trilogy Writing & Consulting is currently looking to hire a Senior Quality Control Specialist (f/m/d) to perform quality control of clinical and nonclinical regulatory documents. The position (onsite or remote) will support our growing company in producing regulatory documentation for the international pharmaceutical industry. 

Applicants must live in one of the following countries: Germany, UK, Portugal, Italy, Ireland (freelancers need not apply) and must have the following skills and experience: 

• A minimum of 3 years’ /relevant experience as a QC Specialist in a clinical regulatory setting 

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

• Fluent written and spoken English skills 

• Performed QC activities on at least 5 different key regulatory documents (e.g., CSR, CSP, Module 2.7 summary for CTD) 

• Proven ability to correctly identify scientific text (based on a QC test) 

• An appreciation for a well written document and an eye for detail 

• An appropriate skillset to proactively participate in a team with diverse personalities (i.e., good interpersonal skills) 

• Advanced knowledge of MS Office software (i.e., Word and Excel) and Adobe 

• Ability to handle all stages of the QC process on complex documents 

• Managing all interactions with Lead Writers without the support of another QC Specialist 

• Oversight and coordination of other QC Specialists who are supporting them as the Lead QC Specialist on a complex QC project 

• Understanding when to request support from other QC Specialists to meet deadlines, if required 

• A positive attitude and an ability to work under pressure, find pragmatic solutions to problems, and maintain oversight of QC activities across a complex project 

Responsibilities for this position will include: 

• Function as an independent QC Specialist on any QC project. For example, you must be able to: 

• Check that all numbers used in text and tables and statements based on data are correct using the source tables, figures, or listings 

• Ensure the text is in line with the required style guide to ensure consistency in hyphenation, capitalization, formatting of references, Word styles, etc… 

• Check text to ensure it is well written, logically structured, and consistent with the supporting data 

• Check facts and raise queries with the author 

• Check tables/figures and captions are correct 

• Support other QC Specialists and/or cover absences on any project 

• Support other medical writers in simple writing and other activities involved in the preparation of documents (e.g., creating a List of Abbreviations, populating tables with data or checking literature references) 

• For projects on which they are the Lead QC Specialist 

• Monitor QC timelines 

• Attend meetings with clients, as needed, to coordinate and proactively manage client QC activities 

• Oversee and coach Associate QC Specialists 

• Be a Client QC Manager for a specific client 

Trilogy offers the following: 

• Competitive base salary (dependent on experience level and the company’s compensation practices) 

• Annual bonus based on company and individual performance. 

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

• Additional country-specific benefits 

• Free weekly yoga sessions 

• Other fun and exciting events to encourage team bonding and development. 

Trilogy Writing is a dynamic, growing company with offices in Frankfurt, Germany, Cambridge, UK and Durham, NC, USA. We provide services to a broad range of pharmaceutical companies who are among the best-known names in the European and US pharmaceutical industry. We value our people and offer a competitive salary and a wide range of benefits. Visit our website to get further insight into who we are (Trilogy Writing & Consulting). 

If you meet the listed requirements, you will be asked to complete a QC test on a 30-page CSR. 

Please submit your cover letter and CV on our careers website (Trilogy Writing Jobs). 

Applicants who do not meet the experience specified above will not be considered. 

Trilogy Writing & Consulting complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state/provincial, and local law. We passionately believe in creating a supportive environment in which everyone can grow, flourish, and do their best work. 

 

It is important to Trilogy to ensure the highest possible degree of protection for your personal data. All personal data collected and processed within the scope of an application for employment with Trilogy are protected against unauthorized access and manipulation by technical and organizational measures and are not forwarded to third parties. Your data will be collected for the purpose of filling employment opportunities offered by Trilogy Writing & Consulting GmbH in Germany or its subsidiaries Trilogy Writing & Consulting Ltd in the UK, and Trilogy Writing & Consulting, Inc. in the USA. By submitting your data with this application, you consent to its use for this purpose within Trilogy. You can revoke this consent at any time without needing to give a reason. In the event of revocation, we will delete your personal data immediately.