BioSRL - Protocol Designer/Senior Medical Writer (4-8 yrs)
Protocol Designer/ Sr. Medical Writer: BA/ BE Studies:
Location : Mumbai, Mira Road
Designation : Protocol Designer/ Senior Medical writer
Principle duties and responsibilities of Protocol Designer :
1) Responsible for Project Assessment and initiation.
2) Preparation of feasibility reports for projects and providing the same in the Study Protocol.
3) Deliver business proposals, cost scientist comparison, negotiation and finalization.
4) Conducting literature search for drug molecules.
5) Responsible for sponsor's query resolution related with protocols.
6) Preparation of study protocol for BA/BE studies.
7) Preparation of study documents Inform consent form, case report forms for BA/BE studies and other study related documents
8) Responsible for ensuring that the projects are progressing according to contract and quality standards, SOPs, ICH-GCP and available regulatory guidelines
9) Compilation of study related documents.
10) Coordination with ethics committee for the approval of study protocol.
11) Preparation and submission of documents to regulatory authorities.
12) To effectively manage timelines and communications for all across departments in order to achieve target filling date.
Interested candidates can send their resumes
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