Senior Specialist, Submission Management
Posted on: 24 Jan 2021
Princeton, NJ
Job Description
At Bristol Myers Squibb, we are inspired by a single vision transforming patients lives through science. In oncology, hematology, immunology and cardiovascular disease and one of the most diverse and promising pipelines in the industry each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
* Drives the execution of the Global Submission Plan through collaborating with team members and vendors.
* Tracks the progress of all components for submissions to health authorities.
* Interacts with responsible parties to aid in ensuring that components are received in a timely manner and provide direction to assure quality results are produced.
* Assures regulatory guidelines are followed for electronic format and review both submission ready documents and dossiers for compliance to these guidelines.
* Demonstrates a good working knowledge of global regulatory practices and requirements and supports liaisons, CMC, Safety, and other regulatory functions as appropriate.
* In depth knowledge of dossier production and provides advice, mentoring, and guidance regarding regulatory and submission requirements, submission strategies, dossier content, and format.
* Supports research for legal due diligence activities, document and submission management for acquisitions, partnerships and divestitures, assisting in internal audits and regulatory agency inspections
* Other miscellaneous regulatory operational activities (e.g. US export waivers, translation document management, etc.)
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
Celgene
Summit, NJ
Celgene Corporation, a biopharmaceutical company, discovers, develops, and commercializes therapies for the treatment of cancer and inflammatory diseases worldwide. It offers REVLIMID, an oral immunomodulatory drug for multiple myeloma (MM), myelodysplastic syndromes (MDS), and mantle cell lymphoma; POMALYST/IMNOVID to treat multiple myeloma; OTEZLA, a small-molecule inhibitor of phosphodiesterase 4 for psoriatic arthritis and psoriasis; and ABRAXANE to treat breast, non-small cell lung, pancreatic, and gastric cancers.
The company’s products also include IDHIFA for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (rrAML) with an isocitrate dehydrogenase-2 mutation; VIDAZA, a pyrimidine nucleoside analog for intermediate-2 and high-risk MDS, chronic myelomonocytic leukemia, and AML; THALOMID to treat patients with MM; and ISTODAX, an epigenetic modifier. Its preclinical and clinical-stage product candidates include small molecules, biologics, and cell therapies for immune-inflammatory diseases, myeloid diseases, epigenetics, protein homeostasis, and immuno-oncology.
The company has agreements with BeiGene, Ltd; Acceleron Pharma, Inc.; Agios Pharmaceuticals, Inc.; bluebird bio, Inc.; Lycera Corp.; Juno Therapeutics, Inc.; EXSCIENTIA LTD.; and IMIDomics SL, as well as immuno-oncology collaboration with Sutro Biopharma. Celgene Corporation was founded in 1980 and is headquartered in Summit, New Jersey.
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IndustryBiopharmaceuticals
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No. of Employees8, 852
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Website
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Jobs Posted1399
