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We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations be future ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship, and is guided by passion, innovation, collaboration and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out www.careers.indegene.com 

What if we told you that you can move to an exciting role in an entrepreneurial organization without the usual risks associated with it?  

We understand that you are looking for growth in your career at this point and we would love for you to join us in our journey and grow with us. At Indegene, our roles come with the excitement you require at this stage of your career with the reliability you seek. We believe in creating leaders of tomorrow and mentor our leads to help them grow and nurture them as people managers and account managers.  

We are a rapidly growing global organization and are scouting for the best talent for this phase of growth. With us, you are at the intersection of two of the most exciting industries of healthcare and technology. We offer global opportunities with fast-track careers while you work with a team that is fueled by purpose. The combination of this will lead to a truly differentiated experience for you.  

If this excites you, then apply below.  

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

As a Senior QC Specialist you will 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.  

Your impact:  
About you:  

• 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

You will be responsible for:  

• 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  
• need not apply. 
• Submission of documents in English: 
• Cover letter specifying how you comply with the experience requirements listed above 
• CV

EQUAL OPPORTUNITY 

Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, candidate’s merit and qualification. 

We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.