Nibr Global Regulatory Submission Manager - East Hanover, NJ Or Basel

Novartis Pharmaceuticals East Hanover , NJ 07936

Posted 2 months ago

Job Description:
150 plus global submissions ranging from INDs/CTAs to NDAs for you to be involved in your role as Submissions Manager as part of the Clinical Sciences & Innovation team within NIBR's Translational Medicine group.

The Novartis Institutes for BioMedical Research (NIBR) is the innovation engine of Novartis, focusing on powerful new technologies that have the potential to help produce therapeutic breakthroughs for patients. NIBR includes about 6500 associates across 7 locations worldwide. Translational Medicine (TM) is the clinical research arm of NIBR, and includes about 1000 associates globally. TM plays a pivotal role in bringing innovative medicines to patients, by building on research advances to develop new therapies, and bridging drug discovery and clinical application. Within TM, Clinical Sciences and Innovation (CS&I) is a dynamic group of clinical scientists who plan and manage all NIBR's Phase I and Phase IIa clinical trials worldwide, ensuring they run smoothly, on time and most importantly with patients' interests to the fore.

In the Global Regulatory Submission Manager role your responsibilities will include but are not limited to:

  • Lead the global NIBR submission team and manage NIBR deliverables for submissions such as INDs, IMPDs and CTA, Health authority responses and annual reports.

  • Develop and track timelines for NIBR components of submissions by partnering with NIBR authors and contributors

  • Serve as the subject matter expert for the above submission activities and provide guidance to line functions.

  • Support senior team members on NDAs and MAAs.

Position can be based in East Hanover, NJ or Basel, Switzerland

Employment Type

Regular


icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Full Time Administrative Assistant East Hanover NJ

Bright Horizons

Posted 3 days ago

VIEW JOBS 4/20/2019 12:00:00 AM 2019-07-19T00:00 Job Description Bright Horizons' Novartis Early Learning Center in East Hanover is looking for a full time Administrative Assistant to join their team! As an Administrative Assistant, you will manage the business, computer and communications functions of the center. Organize and operate the center's office systems while representing the company and the center positively to the community. Update and maintain center files in an orderly manner in accordance with state and federal regulations and within Bright Horizons Family Solutions guidelines. Provide all necessary reports and paperwork as needed. Coordinate and distribute center correspondence. Greet all visitors and ensure that all security procedures are upheld. Monitor sign-in and sign-out procedures. Answer all calls in a courteous manner, route calls, take messages and provide information to customers. Maintain appearance of front lobby, office and common areas. Maintain center calendar. Support the leadership and administrative team. Maintain positive relationships with parents, children and co-workers. Ensure safety and supervision of children at all times by meeting the physical demands of the position. Job Requirements * Must be 18 years of age and have a high school degree or GED. * Associates Degree in Business, Secretarial, related field or ECE (Early Childhood Education) degree preferred. * Experience in an office setting and excellent verbal and written communication skills. * Computer proficiency. * Strong organizational skills and ability to maintain high level of confidentiality is essential. Additional Information Bright Horizons is dedicated to creating a workforce that promotes and supports diversity and inclusion. We provide equal employment opportunities to all individuals without discrimination. Bright Horizons complies with the laws and regulations set forth in the following EEO is the Law Poster: EEO IS THE LAW. Applicants requiring reasonable accommodation for any part of the application and hiring process should contact the recruitment helpdesk at 855-877-6866 or bhrecruit@brighthorizons.com. Determinations on requests for reasonable accommodation will be made on a case-by-case basis. Having technical issues with your online application? Contact us at bhrecruit@brighthorizons.com or 855-877-6866. Bright Horizons East Hanover NJ

Nibr Global Regulatory Submission Manager - East Hanover, NJ Or Basel

Novartis Pharmaceuticals