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Senior Scientist I, CMC Position
1 month ago
AbbVie is seeking a highly skilled Senior Scientist I, CMC to join our team. As a key member of our regulatory affairs team, you will be responsible for coordinating cross-functional data gathering and preparing high-quality CMC sections for regulatory submissions.
Key Responsibilities- Author CMC submission documentation for all phases of clinical development, ensuring compliance with global regulatory requirements.
- Develop and implement efficient processes for preparing CMC sections, ensuring timely and cost-effective delivery.
- Collaborate with internal and external stakeholders to gather data and ensure alignment with clinical/regulatory development strategy.
- Manage completion of CMC regulatory submission documentation for multiple projects, utilizing a matrix management approach.
- Develop and maintain expertise in regulatory guidance documents and coordinate authoring and reviews across CMC functions.
- Bachelor's Degree with at least 8 years of CMC functional experience; Master's Degree with at least 6 years of CMC functional experience or PhD Degree with at least 2 years of CMC functional experience.
- Excellent scientific writing skills and working knowledge of regulatory requirements.
- Excellent communication skills, written and verbal, with a demonstrated ability to summarize and communicate findings in a timely and efficient manner.
- Demonstrated ability to make decisions based on scientific data, to manage and prioritize multiple projects simultaneously, and to work with a sense of urgency.
- Demonstrated skills in negotiation, influencing others, and leadership.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.
