Work as Manager- Clinical Research/Medical Monitor in Panacea Biotec

Panacea Biotec is a leading research based Health Management Company. We are engaged in research, development, manufacture & marketing of Vaccines, Bio-Pharmaceuticals and Pharmaceuticals (Rx & OTC) of international quality and Health Services. All Panacea Biotec plants are accredited by international agencies and they follow current Good Manufacturing Practices, as per WHO guidelines.

We offer stimulating work environment & a career that spells growth. In tune with our plans, we require young, aggressive, dynamic, high performing and result oriented professional.

Post: Manager- Clinical Research/Medical Monitor

Job Description
- Assisting in Planning, execution and scheduling of Clinical trials/BA -BE studies and supervision of activities of clinical trial monitors for global markets including US.
- To provide complete regulatory support for uploading formats and dossier compilation protocol training and medical support to the study team during site evaluation, selection, regulatory and EC approvals, study initiation, conduct and closeoutexecute discussions with CRAs and project manager
- To do medical writing for regulatory submissions for products
- Interact with the scientist to understand product requirements for preparing BA/BE protocol summary for circulation and submission of draft protocol to regulatory authorities.
- Review & prepare clinical trial/ BA - BE study documents & SOP's
- To be a sponsor’s medical monitor for in-house as well as outsourced clinical trials/BA – BE studies for global markets
- To ensure presentation/publication of the results of clinical trials/ BA – BE studies in national/international conferences and journals
- To coordinate with partner CROs for Protocol and other Clinical trial document finalization, and providing medical support during Site evaluation, selection, regulatory and EC approvals, study initiation, conduct and closeout for outsourced clinical trials/BA – BE studies
- To provide complete regulatory support for study uploading to eCTD format and dossier compilation

Additional Information:
Experience: 6-10 Years
Age: 30-40 years
Location: New Delhi
Compensation: As per the Industry
Education: MBBS/MD
Industry Type: Pharmaceutical or Vaccine
Functional Area: Medical Monitor/ Clinical trials/BA – BE studies.
Last Date: 15^th Oct., 2015