CMC Technical Writer - France

Created in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care.

We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 800 Excelyates. Our unique one-stop provider service model – leveraging full-service, functional service provider and consulting – allows our Excelyates to evolve through a diverse array of projects. In collaboration with preeminent experts, Excelya advances scientific, managerial and human knowledge to improve the patient journey.

For our team members, excelling with care means benefitting from a stimulating professional environment that encourages personal, intellectual, and operational participation so that together we can be the best in our field. We commit to giving each Excelyate the means to express their natural talents, develop their full potential and invest their unique selves in our unique project.

What we offer:

Responsibilities:

Prepare, review, and finalize high-quality regulatory submission documents for late-stage clinical phase applications (Phase 3) and marketing applications for small molecule, oligonucleotide, and biopharmaceutical therapeutic assets.
Write drug substance and drug product CMC sections of regulatory submissions including Module 2.3 and Module 3 of the CTD, which may include briefing documents for Health Authority consultations, as applicable.
Work closely with CMC teams, including formulation, process development, analytical, and manufacturing groups to gather and compile necessary information for regulatory submissions.
Contribute to authoring and maintaining CMC regulatory dossier templates. Templates to be updated based on evolving guidelines relevant to CMC and ensure compliance in all submissions working closely with CMC regulatory policy and intelligence.
Work closely with regulatory submission managers.
Manage CMC regulatory submission workflows within the document management system within the company.
Ensure accuracy, consistency, and completeness of data and narratives within regulatory documents.
Manage timelines and deliverables for multiple projects, ensuring that all deadlines are met and potential delays are communicated in a timely manner.

Minimum Requirements :

ducation and Required Skills

Degree in Pharmacy or a relevant science/technical subject such as chemistry, biology, or related field.
Minimum of 5 years within a CMC role in the pharmaceutical industry, with at least 3 years being directly involved with a CMC regulatory submission technical writing role.
Knowledge of CMC-related regulatory requirements and guidelines (e.g., ICH, FDA, EMA) and experience with eCTD submissions.
Solid technical writing skills with the ability to communicate complex scientific information clearly and concisely.
Meticulous attention to detail and accuracy in all aspects of work.
Excellent interpersonal and communication skills with the ability to work effectively in a team-oriented environment.
Strong organizational and project management skills with the ability to prioritize and manage multiple tasks simultaneously.
Proficient in MS Office applications and information regulatory information management software (e.g., eCTD, Veeva).
Proficient in written and spoken English.