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 Senior Manager – CMC Dossier Manager (M/F) !

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MAIN RESPONSIBILITIES:

The CMC Dossier Manager (M/F) is responsible, with limited guidance from the manager, for developing the technical eCTD sections to support Regulatory CMC dossier applications. With limited guidance from the manager, coordinates and provides technical oversight for the generation of the CMC dossier of marketing and clinical trial 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 limited supervision from the manager. Represents the department on multi-functional project development teams to support regulatory filings. Has expertise in appropriate CMC regulatory applications.

JOB SCOPE / SPAN OF INFLUENCE :

• Contributes to dossier strategy/complex product development plan creation at a compound level and to limited degree at a functional level
• Communicates and executes dossier strategy/product development plan with high level of autonomy and accountability
• Leads and supervises dossier authoring activities for early and late stage projects with limited or no guidance from manager
• Identifies business improvement areas and helps, under regular supervision of the manager, drive implementation of improvements

Develops process and business improvements within own functional organization, and aligns with other departments as needed, with managerial support.
• With limited or no guidance, interfaces directly with CMC/Tech team members, Regulatory, external service providers and internal stakerholders.
• Interfaces with internal and external functional stakeholders
• Influences or persuades others to accept new ideas, approaches or concepts or gains alignment on divergent issues with limited guidance.
• Combines technical expertise with team working skills. Coaches/mentors others on a regular basis.
• Manages several complex projects with potentially accelerated or standard priority OR leads complex programs.
• Challenges status quo and has ability to assist in identifying innovative approaches to improve products/processes
• Scope is a mix of incremental and transformational innovation, within own dept/team.
• Independently resolves isolated cross-functional issues.
• With regular guidance, appropriately identifies and manages key stakeholders, and escalates when needed to obtain senior management support
• Works independently on a day to day basis, checks in with supervisor as needed for identified high-priority issues
• Acts as a mentor to one or more individuals
• May coach project teams.

EXPERIENCE & EDUCATION:

• Strong background in Gene therapies, Technical Dossier Writing and Development
• Technical Regulatory CMC Biologics experience, including BLA, MAA etc
• Strong expertise concerning recombinant proteins or Large Molecules
• PhD with Post-doc experience with 8+ years relevant experience OR University degree with 12+ years relevant experience OR Equivalent by experience

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