CMC Technical Content Creator
7 days ago
Proclinical Staffing seeks a skilled CMC Technical Content Creator to create and drive sections of the CMC dossier, ensuring compliance with regulatory requirements. The successful candidate will support technical functions in developing responses to health authority inquiries and ensure completeness, accuracy, and compliance of data for regulatory submissions.
As a key member of the team, you will contribute to dossier strategy and product development plans, leading and supervising dossier authoring activities for early and late-stage projects. You will also identify and implement business improvements within the functional organization, interfacing with CMC/Tech team members, regulatory bodies, external service providers, and internal stakeholders.
Key Responsibilities:
- Create and drive sections of the CMC dossier, ensuring compliance with regulatory requirements.
- Support technical functions in developing responses to health authority inquiries.
- Ensure completeness, accuracy, and compliance of data for regulatory submissions.
- Contribute to dossier strategy and product development plans.
- Lead and supervise dossier authoring activities for early and late-stage projects.
- Identify and implement business improvements within the functional organization.
Requirements
We are seeking a candidate with a PhD alongside post-doc experience and relevant years of working experience OR University degree with proven years of relevant experience. Recent BLA experience for recombinant proteins is a necessity. A strong background in gene therapies, technical dossier writing, and development is required. You must be able to work independently with limited guidance and have excellent communication and team-working skills. Experience in managing complex projects and leading programs is also necessary.
This is a remote working position that requires a high level of autonomy and accountability, with a focus on timely and accurate quality submissions. The estimated salary range for this role is $120,000 - $180,000 per year.
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