Location : Basel, Switzerland 

Who is Aixial Group ? 

Aixial Group, we are a CRO (Clinical Research Organization), specialized in Life Science. We work with laboratories to provide technical support on clinical projects from phases I to IV and post market.

Since 2014, we have been part of the Alten family.

We are developing our activities in Switzerland, France, Belgium, Czech Republic, Denmark, UK, US…with even more prospects for expanding internationally.

Aixial Group, operates in outsouring, insourcing, for pharmaceutical, cosmetic, medical device, biotechnology, nutrition,… activities in clinical operations, regulatory affairs, quality, biometrics, pharmacovigilance, HEOR…

Aixial Group continues to grow, and to recruit in the clinical trial professions. Come and join us, and discover our site to follow the news of our offers.

The Team of Aixial Group Switzerland is looking for his next CMC Technical Writer – DP Drug Product Lyophilization (M/F) !

CORE RESPONSIBILITIES:

The CMC Technical Writer – DP Lyophilization, is responsible, with limited guidance from the manager, for developing the technical eCTD sections to support Regulatory CMC dossier applications.

• Coordinates and provides technical oversight for the generation of the CMC dossier of marketing submissions.
• Coordinates the timeline, virtual document, and the generation of the Quality module.
• Assumes personal ownership and accountability for business results and solutions, working with some managerial supervision.
• Represents the department on multi-functional project development teams to support regulatory filings.
• Represents the department on multi-functional project development teams to support regulatory filings.
• Has technical expertise in appropriate CMC regulatory applications specifically in writing dossier for DP Lyophilization.
• Authors/drives, as appropriate, sections of the CMC dossier and evaluates/ensures that final versions comply with regulatory requirements and fulfill regulatory agency expectations with limited guidance from the manager.
• Supports the technical functions in the development of responses to health authority inquiries in support of major applications with limited guidance from the manager.
• Evaluates and ensures the completeness, accuracy and compliance of data provided for all regulatory submissions with limited guidance from the manager.
• Ensures all Quality submissions are completed in a timely manner.

REQUIREMENTS:

• Relevant PhD with Post-doc experience with 6+ years relevant experience
• OR University degree with 8+ years relevant experience
• Experience with Biologics/Large Molecules CMC Technical Writing
• Preferred experience with BLA or MAA

Why Join Us?

• Make a positive impact and be at the forefront of project: You will be part of ground breaking advancement in clinical research that has positive impacts on millions of people’s lives globally.

• Career Development: People are our biggest asset. We are committed to empower our team continually and build a positive and supportive environment that fosters growth, flexibility, and teamwork. At Aixial Group, you will be coached and mentored throughout your journey to help you advance your professional and personal growth.

• Our commitment to Diversity, Equality, and Inclusion: We aim to create a workforce which promotes dignity and respect, where individual differences are recognized and valued, and where each employee can give their best. Gender equality is at the core of the development strategy of Aixial Group.

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#TogetherWeCreateValue