Job ID :133148BR
Position Title : Senior Medical Writer
Division : Vaccines & Diagnostics
Business Unit :Global Development
Country : India
Work Location : Hyderabad
Company/Legal Entity : Nov Hltcr Shared Services Ind
Functional Area : Development & Medical
Job Type : Full Time
Employment Type : Regular
Job Description
To meet the business need of writing high quality clinical study documents for submission to regulatory authorities in support of marketing applications and other medical writing needs through writing and coordinating, timelines and quality, managing customer expectations and providing other medical writing support to global teams. • Write, edit and co-coordinate preparation of Clinical Study Reports (CSR) • Drive the CSR process and coordinate a medical and scientific team within a matrix • Participate in review of analysis plan and advise on required tables • Develop and maintain effective working relationships among document contributors on multifunctional platforms • Ensure reviewers and other contributors are identified and can perform tasks according to the agreed process • Ensure CSR process is completed according to SOP within the time specified by the SOP or otherwise agreed with the team, whicever is shorter. • CSR tracking and status reporting, including identifying milestone timelines • Contribute to the development of both, the CSR process and product, to match changing business needs • Obtain feedback from customers; and help define and implement customer management • Support process improvement initiatives • Comply with and support group's project management tool, standards, policies and initiatives • Maintain records for all assigned projects including archiving • Help maintain audit, SOP and training compliance • Train and mentor new joiners, fellow colleagues as and when required
Minimum requirements
B.Sc/ M.Sc in a scientific discipline, Doctoral Degree or MD is desiredDesired – Doctoral Degree or Qualification in Medical Sciences (MBBS/MD/equivalent) Fluency in written and spoken English with strong ability to interpret and present data Five years of experience in medical/scientific writing As and when required for trainings, meetings and audits
Apply online
Position Title : Senior Medical Writer
Division : Vaccines & Diagnostics
Business Unit :Global Development
Country : India
Work Location : Hyderabad
Company/Legal Entity : Nov Hltcr Shared Services Ind
Functional Area : Development & Medical
Job Type : Full Time
Employment Type : Regular
Job Description
To meet the business need of writing high quality clinical study documents for submission to regulatory authorities in support of marketing applications and other medical writing needs through writing and coordinating, timelines and quality, managing customer expectations and providing other medical writing support to global teams. • Write, edit and co-coordinate preparation of Clinical Study Reports (CSR) • Drive the CSR process and coordinate a medical and scientific team within a matrix • Participate in review of analysis plan and advise on required tables • Develop and maintain effective working relationships among document contributors on multifunctional platforms • Ensure reviewers and other contributors are identified and can perform tasks according to the agreed process • Ensure CSR process is completed according to SOP within the time specified by the SOP or otherwise agreed with the team, whicever is shorter. • CSR tracking and status reporting, including identifying milestone timelines • Contribute to the development of both, the CSR process and product, to match changing business needs • Obtain feedback from customers; and help define and implement customer management • Support process improvement initiatives • Comply with and support group's project management tool, standards, policies and initiatives • Maintain records for all assigned projects including archiving • Help maintain audit, SOP and training compliance • Train and mentor new joiners, fellow colleagues as and when required
Minimum requirements
B.Sc/ M.Sc in a scientific discipline, Doctoral Degree or MD is desiredDesired – Doctoral Degree or Qualification in Medical Sciences (MBBS/MD/equivalent) Fluency in written and spoken English with strong ability to interpret and present data Five years of experience in medical/scientific writing As and when required for trainings, meetings and audits
Apply online
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