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Head Medical Writing and Regulatory Affairs

10.00 to 12.00 Years   Kolkata   08 Sep, 2019
Sygene
Job LocationKolkata
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaSBU Head / CEO / Director
EmploymentTypeFull-time

Job Description

1] Head - Medical affairs (MA):

  • Overall responsibility for all activities carried out by the MA.
  • Review of departmental SOPs and training of MA personnel and stake holders on same.
  • Preparation. review, approval and amendments of clinical trial related documents like protocols, ICFs. data collection tools (except CRF), clinical study reports as per the departmental SOPs.
  • If designated as Medical Monitor for a specific clinical trial project, carry out the responsibility of safety management. Review serious adverse events (SAE) reports and ensure reporting of SAEs according to applicable regulations and sponsor requirements.
  • Review and follow-up of pregnancy events as a Medical Monitor of a particular clinical trial project.
  • Provide expert assistance in all phases of a trial e.g. during recruiting, data collection etc.
  • Guidance to designated Project Physician during analysis and report writing in co-ordination with Sponsor.
  • Performance appraisal of MA Personnel.
  • Financial management of MA activities and projects.
  • Co-ordination with the Legal department for finalizing all relevant agreements and contracts necessary during the conduct of in-house clinical trials.
  • Prepare & Co-ordinate for CQA Audits.
  • Work towards the companys business objectives.
  • Infrastructure/ manpower requirements identification.
  • Carry out any other job assigned by Head of Clinical Development from time to time.
2] Head - Regulatory Affairs:
  • Overall responsibility for the activities carried out by the Regulatory Affairs department.
  • Review and approval of departmental SOPs and training of RA personnel and stake holders on same. Whenever Required.
  • Overall responsibility for the registration of the clinical trials with Clinical Trial Registry - India (CTRI) wherever applicable.
  • Review of application along with the documents/information required for obtaining permission to conduct clinical trials/ BNBE studies and procuring licenses (Import, and Export NOC) wherever applicable.
  • Review of the Safety reports and Clinical study progress reports for the compliance as per the prevailing requirement of the Regulatory authority wherever applicable.
  • Responding to the queries if any. raised by the regulatory authority regarding application to conduct clinical trials, BNBE studies, Licenses.
  • Communicating with the Regulatory authorities for study related issues wherever applicable.
  • Coordinating with the sponsor on study related issues wherever applicable.
  • Review of document Syngene Clinical Development Site Master File for its completion.
  • Performance appraisal of RA personnel.
  • Financial management of RA activities and projects.
  • Co-ordination with the Legal department for finalizing all relevant agreements and contracts necessary during the conduct of RA functions.
  • Work towards the company s business objectives.
  • Infrastructure/ manpower requirement identification.
  • Carry out any other job assigned by Head of Clinical Development from time to time.
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Keyskills :
adverseevents datacollection clinicaltrials clinicaldevelopment clinicalstudy clinicaltrial cqa trials medical writing training business analysis clinical tudyrep rep twriting regulat yaffairs exp

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