Biopharmaceutical Documentation Lead
1 day ago
About the Position
">The Senior Technical Documentation Specialist will play a critical role in the creation and management of CMC documentation for biopharmaceutical products. This individual will be responsible for ensuring the accuracy, completeness, and compliance of data for regulatory submissions, as well as contributing to dossier strategy and product development plans.
">Responsibilities:
">- ">
- Develop and maintain high-quality CMC documentation, including regulatory reports and submission packages.">
- Collaborate with cross-functional teams to ensure alignment and consistency in documentation standards.">
- Provide expertise and guidance on regulatory requirements and industry best practices.">
- Lead and supervise documentation authoring activities for early and late-stage projects.">
- Identify and implement process improvements to enhance efficiency and productivity.">
Requirements:
">- ">
- Advanced degree (PhD or equivalent) in a life science or related field, with relevant postdoctoral experience.">
- Proven track record of success in CMC documentation and regulatory affairs.">
- Excellent communication and interpersonal skills, with the ability to work effectively with diverse stakeholders.">
- Strong analytical and problem-solving skills, with the ability to interpret complex regulations and guidelines.">
- Ability to work independently and collaboratively in a fast-paced environment.">
Salary Range:
">$160,000 - $220,000 per year
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