SENIOR SCIENTIST CMC DOSSIER DEVELOPMENT (GHENT)

Consultancy

Information

THE COMPANY The company is a commercial stage biopharmaceutical company that is creating and developing a deep pipeline of differentiated antibody therapeutics. We offer you the chance to join a unique opportunity to contribute to the development of innovative therapeutics to treat patients with severe auto‐immune diseases. JOB DESCRIPTION You will contribute to the CMC development of pre‐clinical, clinical and commercial stage programs in close collaboration with the CMC team members by: - Participate to the authoring and preparing for clinical trials: IND , IMPD, scientific briefing documents, investigator brochures and regulatory agency response documents for therapeutic compounds in development in close collaboration with external and internal stakeholders; - Participate to the authoring and preparing of CMC regulatory documentation for new filings (BLA, J‐MAA, MAA and ROW applications (module 2 and 3) and related life cycle documents); - Ensuring submission packages are complete and compliant with applicable regulatory and country specific requirements; - Coordinating activities with external partners ensuring that deliverables are executed with the right priorities and to the required standards; - Authoring technical source protocols and reports related to drug development activities; - Providing strategic input into CMC development activities; - Tracking execution of regulatory commitments.
MindCapturebooth 48MindCapture is a talent and consultancy company, providing advanced consultancy solutions to the biotech, pharma, medical devices & IVD, lab, healthcare and the chemical industry. The idea of an agile talent consulting company was conceived to cope with the drastic increase in high value and high quality talents in the life sciences industry. At MindCapture, we combine scientific experience and job content with high level consultancy advice. We work with a strong referral program for key positions in innovative organisations. In order to match this demand for expertise, the MindCapture team built a smart matching process, resulting in an AI driven SaaS platform “SmartlyMatched”, based on solid understanding of the scientific and technical job content and the understanding of the ambitions of the talents. This way, we can provide the best consultants for the job or the best project for our consultants. Our team members have a solid scientific background, combined with years of experience in the life sciences industry. We have built agile outsourcing programs for 6 specific expertise domains: QA/RA, validation, data analysis, project management, lab IT, scientific business development. Let us together inspire talents as well as companies, to expand each other’s comfort zones, hence stepping into promising new talent-project combinations.

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