lithasem.blogg.se - Brunswick bristol ii

#Brunswick bristol ii full#
#Brunswick bristol ii trial#

This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana.

#Brunswick bristol ii full#

and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture. 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. 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.īristol Myers Squibb recognizes the importance of balance and flexibility in our work environment.

Ability to interpret global regulations and guidanceĪround the world, we are passionate about making an impact on the lives of patients with serious diseases.

Prepare and manage filings and ensure thoroughness, accuracy and timeliness

Ability to identify, communicate and resolve routine/complex issues.

Demonstrated ability to develop/maintain strong working relationships with the regulatory CMC team and cross functional teams, participate on and/or lead multifunctional teams, handle and prioritize multiple projects and work independently.

Knowledge of pharmaceutical development, including drug substance and drug product and analytical methods.Knowledge of CMC regulatory requirements during development and post-approval.CMC regulatory experience, including post-approval experience desired.4+ years CMC regulatory or related experience. Minimum of Bachelor's Degree, scientific discipline, with 6+ years pharmaceutical or related experience (min BA/BS).Utilize electronic systems for dossier creation and tracking regulatory information.Manage collaborative relationships with diverse teams.Prepare and manage CMC submissions for all global markets while ensuring thoroughness, completeness and timeliness, including creation and maintenance of strategy documents.Review and provide regulatory assessments on change controls (commercial and/or development products).

#Brunswick bristol ii trial#

Represent regulatory CMC on matrix teams while providing strategic guidance related to current regulatory requirements and expectations for marketing applications and/or clinical trial applications for small molecule projects.

We bring a human touch to every treatment we pioneer. 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. At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science.