Project Coordinator II/ Project Manager, Discovery
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
In partnership with Discovery Project and Safety Pharmacology teams, prepare non-clinical regulatory documents which will be used to support global clinical trial and marketing applications. The Discovery regulatory submission coordinator/project manager will be responsible for ensuring the standardization of Discovery pharmacology reports across Discovery sites, the coordination and quality assurance of summary documents submitted to global regulatory agencies and the management of non-clinical regulatory timelines for multiple assets. The Discovery regulatory submission team works collaboratively with Discovery Project teams, DMPK, Toxicology, and Regulatory Affairs Project Management. The Discovery regulatory submission team is responsible for ensuring the incorporation of non-clinical pharmacology into global regulatory filings through the regulatory submission process. By having knowledge of both drug discovery and the regulatory submission process, the coordinator/project manager is in the unique position to ensure that regulatory submissions supporting clinical trials proceed in a timely manner.
- As the Discovery primary contact, responsible for the management of non-clinical regulatory deliverables for global regulatory submissions.
- Collaborate with Discovery project teams, Development Science, Clinical Medical Writing and Regulatory Affairs to ensure timely delivery of accurate, standardized non-clinical regulatory documents across all Discovery sites.
- Write and ensure quality of reports, IB, IND, IMPD and NDA scientific summaries and coordinate queries from regulatory agencies.
The position grade level can be adjusted commensurate with education and experience levels.
- Degree in Biology (molecular biology, biochemistry, or pharmacology)
- PhD & 0-4+ years of experience
- Masters & 5-8+ years of experience
- Bachelors & 7-10+ years of experience
- This role requires a scientific background with experience; preferentially in a drug discovery laboratory and familiarity with the drug discovery process.
Significant Work Activities
Yes, 5 % of the Time
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.