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 I clinical and regulatory documents developed within the department.
• Learns and adheres to SOPs, templates, internal standards, and regulatory guidelines and regulations.
• May participate in process working groups for writing processes within CPP.
• Complete all time reporting and training as required in relevant company systems

Minimum Qualifications / Experience

• A university/college degree in scientific discipline is required. An advanced degree (eg, Masters, PhD, MD) is preferred.

Minimum Technical Knowledge and Skills:

• Proficiency in written and spoken English is essential, along with the ability to collaborate with global teams and stakeholders across time zones, requiring some flexibility in your daily routine.
• Good technical skills with MS Word.
• Desire to learn how to interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in various document types under supervision.
• Learns and applies knowledge of regulatory guidance documents such as ICH requirements.
• Demonstrate learning agility (self-development).
• Apply relevant technical trainings/learnings to daily responsibilities, with focus on opportunistic delivery of value/impact.
• General understanding of overall process of drug development and clinical data is a plus.
• Attention to detail, proficient in time and project management
• Adding value to the organization assuming responsibility and accountability for successfully completing assignments or tasks.
• Builds and maintains solid and productive relationships with cross-functional team members.

Other Requirements:

• Estimated both domestic and international travel of about 5% of time.

 

 

Required Skills:

 

 

Preferred Skills:

Analytical Reasoning, Clinical Data Management, Clinical Operations, Clinical Pharmacology, Data Savvy, Detail-Oriented, Drug Discovery Development, Execution Focus, Pharmacokinetic Modeling, Pharmacokinetics, Pharmacometrics, Regulatory Environment, Relationship Building, Report Writing, Scientific Research, Study Management, Technologically Savvy