CMC Project Manager
- Employeur
- Profile Group
- Lieu
- Liège
- Date de clôture
- 8 août 2021
Détails de l'offre
La société
Our client Aquilon Pharmaceuticals is a company active in the development of innovative drugs in the respiratory field. As the company is growing, they are currently looking for a Project Manager (CMC)
Function
Your Mission:
The successful candidate will contribute as Project Manager to the development and execution of Regulatory CMC strategies, submissions and compliance activities from development to market and post-marketing, including the preparation and submission of correspondence and applications (IMPD’s, MAA’s,…) to regulatory agencies.
Your responsibilities:
As Project Manager (CMC) you will also:
- Undertake the full responsibilities for the development of products (planning, coordinating and supervising the activities of products developed by external centres and reporting their progress to the Management, other departments and partners), including leading and directing the formulation development,
- Ensure that R&D department meets the timelines and manage delays, negotiate delivery time and cater efficient information flow between internal and external teams,
- Plan and negotiation of Project budgets and assessment of appropriate project scopes.
- Manage external providers related to the CMC activities.
Profile
Your profile:
Hard skills:
Soft skills:
- Strong interpersonal skills with the ability to influence others in a positive and effective manner
- Demonstrated ability to contribute to a continuous learning and process improvement environment
- Proven track record in product management or equivalent with knowledge of product management techniques and tools.
- Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies.
- Ability to understand and analyze scientific data and results and review scientific documents including drug development reports, publications and regulatory submissions.
- Strategic thinking, strong problem-solving and analytical skills
- Understanding the scientific principles and regulatory requirements
- Communication and motivation skills
- Ability to work in a team
- Detailed oriented
- Strong sense of planning and prioritization
- Good understanding of and respect for cultural differences and the capacity to work effectively in a multicultural environmen
Offer
Our offer:
- Stimulating challenges in a flexible & fast growing Start-up
- Expert and passionate colleagues with friendly working surrounding
- Career growth as the company grows
- Autonomy and independence
Languages
- Excellent knowledge of English (both spoken and written); with fluency in French being an asset
Entreprise
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