Scientific Writing and Reporting Scientist - Hyderabad

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Job Function:
Discovery & Pre-Clinical/Clinical Development

Job Sub Function:
Pharmacokinetics & Pharmacometrics

Job Category:
Scientific/Technology

All Job Posting Locations:
Hyderabad, Andhra Pradesh, India

Job Description:

Scientific Writing and Reporting Scientist - Hyderabad

Objective of Position:

The Clinical Pharmacology & Pharmacometrics (CPP) Scientific Writing & Reporting (SWR) Scientist is responsible for writing documents, coordinating reviews and document finalization, performing document quality control (QC) and managing (e.g.

timelines, resources, and metrics) of documents related to Clinical Pharmacology trials.

They assist in the preparation (in collaboration with the Clinical Pharmacology Leader)of the following activities in support of Clinical Pharmacology Phase 1 studies: Protocol authoring and CSR writing.

In addition, they may create and provide summaries of performed Clinical Pharmacology studies for inclusion in CTD documents.

Additional responsibilities include QC review of documents.

This function liaises closely with stakeholders to ensure timely & high quality delivery of documents, in line with internal standards and processes while adhering to applicable guidelines and regulations.

Main Accountabilities:



* Authors, coordinates, and facilitates timely reviews and approval ofPhase I clinical and regulatory documents such as, but not limited to, CSRs, protocols, and submission summary documents under close supervision.


* Attends cross-functional (eg, with clinical team) document planning and review meetings.

Interacting with CP TA Project Leads, CP Leader, PK Scientists, and cross-functional colleagues on document content and champion writing processes and best practices.

Responsible for establishing document timelines and strategies in accordance with internal processes, with some mentorship from functional management and the study team, as needed.


* Able to function as the Phase I writer on compounds across all therapeutic areas under supervision.

Is primary point of contact for assigned writing activities for the cross-functional team.


* Performs QC of protocols and CSRs of Phase ...