Company Jobs

The Manager Drug Safety Content Analysis will manage and supervise project’s PV Operations/training staff on a day-to-day basis, guiding performance of PV Operations staff in ongoing projects in terms of training, quality of deliverables, compliance with the timelines and relevant trainings.

Develop strategy to configure, distribute, and collect, and review and approve, high quality country specific and or site specific documents or essential regulatory documents and any updated or amended regulatory documentation.

Project Managers provide business and technical leadership for one or more projects within a business unit, leading project teams through the identification, justification, prioritization, initiation, development and implementation processes. This Sr. Specialist position will act as a Project Manager leading commercial launches in US and Global markets within the Pharmaceutical Business segment.

Evaluation and submission of application on online portal for getting domestic manufacturing and marketing permission from DCGI. Evaluation and submission of applications on online portal for import registration, import license of drugs and medical devices in India. 

As an Associate Global Scientific Advisor, you will Provide timely, accurate and credible scientific and medical input for a variety of projects pertaining to scientific communication around Novo Nordisk’s products. Collaborate closely and communicate effectively with various cross-functional stakeholders including colleagues from the US affiliate, global medical affairs, and other functional areas. Engage in dialogue with Key Opinion Leaders (KOLs) in different settings with focus on medical and scientific information. Prepare presentations for Novo Nordisk standalone events and international medical congresses.

Analytical method development, stability samples analysis and impurities identification by using instruments like HPLC, GC, LC-MS, and other analytical techniques.

Write brief narratives summarizing the ICSR criteria and other potentially safety-relevant information in each article. Demonstrates understanding of client’s drugs labels and uses that knowledge effectively when performing the safety assessments.

Compile appendices to clinical study reports in compliance with appropriate regulatory requirements, with support of the project lead and lead medical writer. Work with internal or external Clinical and or Project Leadership functions to ensure that appendix documentation is complete and complies with the relevant guidelines.

You will be responsible for executing or assigning in-process activities during shifts, conducting line clearances, material verification, overseeing start-up of machines, and coordinating sampling activities to ensure product quality and compliance.