Tata Elxsi Hiring Team Lead – Scientific and Medical Writing

Tata Elxsi Hiring Team Lead – Scientific and Medical Writing

17 April, 2022

POSITION SUMMARY:

The Scientific and Medical Writing Team Lead performs the tactical and operational job responsibilities manage day to day operations of assigned delivery teams and assume overall responsibility of delivery, holds expertise in research, creation, and editing of all documents associated with clinical research and regulatory project teams.

The Scientific and Medical Writing Team Lead supports Tata Elxsi Pharma vertical in PV domain, strengthen existing domain capabilities and competencies and develop new domain capabilities. This position is fundamental to building credibility and strengthening relationships with healthcare providers, patients, and industry clients.

RESPONSIBILITIES:

·Mentors and leads less experienced medical writers on complex projects as necessary

·Acts as lead for assigned writing projects

·Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments

·Develops or supports a variety of documents that includes Clinical study protocols and Clinical protocol amendments, Clinical study reports, Patient narratives, Clinical development plans, IND submissions and annual reports, Integrated summary reports, NDA and (e)CTD submissions, Investigator brochures, Clinical journal manuscripts, Clinical journal abstracts and Client presentations

·Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate

·Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency

·Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables

·Serves as peer reviewer on internal review team providing review comments on draft and final documents

·Adheres to established regulatory standards, including but not limited to ICHE3 guidelines, as well as company SOPs, client standards, and company and/or client approved templates when completing medical writing projects

·Performs online clinical literature searches as applicable

·Maintains familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing

·Completes required administrative tasks within the specified timeframes

·Ensure delivery of services in terms of TAT, quality and volumes meets or exceeds Service Level Agreements

·Conducts periodic discussions with the team members, set performance standards, identify gaps if any, implement quick and long term fixes, discuss career paths, check training needs

·Communicate organizational and leadership directions to the team members

·Ensure client and Tata Elxsi training compliance for self and for team members

·Participate in internal and external audits and inspections

·Team Management – Leaves and allocation of resources – Manage volume peaks – Maintain day to day operations

SKILLS AND QUALIFICATIONS:

·Education: Master/ Bachelor in Pharmacy, Medicine, Nursing or Alternative medicine

·Professional with minimum 4-6 years of Medical writing experience with Biotech/Pharmaceutical or CRO industry engaged in Safety services for pharma clients

·3+ years of experience in people management is desirable

·Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information.

·Strong understanding of drug development, drug safety reporting, regulatory guidance and compliance

·Demonstrate proficiency in interpretations of GCP regulations, SAP, and LIMS

·Proficiency in Microsoft Office Suite (Word, Excel and PowerPoint)

·Ability to apply effective interpersonal, verbal, and written communication skills

·Strong attention to detail, ability to multi-task and deliver on deadline

·Able to maintain up-to-date knowledge in area of practice

·Ability to work independently and in a multi-cultural team environment

·Ability to thrive in a fast-paced, constantly changing environment

Job location: Mumbai

Job code: HLSBU 007

Apply through this Link

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