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Mumbai, MH
Job Code:
  • Biotechnology & Science
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Job Details

Job PurposeTo write, edit and manage the production of high quality clinical documentation for submission to regulatory authorities in support of marketing applications . To provide authoritative documentation-related expertise to RMW and other line units. Major Activities1.Act as a member of clinical trial teams and submission teams and write/edit clinical study reports, CTD summary and overview documents, and other regulatory documents, working autonomously. 2.Participate in planning of analysis and data presentation to be used in clinical programs, individual study reports or summary documents.3.Write other strategic documents, as required, in collaboration with project teams and where necessary with guidance from Senior Expert Medical Writers or RMW leadership team members 4.Act as documentation consultant in clinical trial and submission teams to ensure compliance of documentation to internal company standards and external regulatory guidelines.5.Act as project medical writer for complex programs in clinical development. 6.As requested by RMW management, act as lead writer on submissions to ensure provision of adequate medical writing resources and appropriate timelines for dossier preparation and co-ordinate production of summary documentation by medical writing team in collaboration with clinical team.7.Act as liaison between clinical trial teams and publishing to ensure timely delivery of final documents for publishing. 8.Contribute to development of document templates and processes both within RMW and more widely.9.Coach or mentor less experienced medical writers. 10.Supervise outsourcing to external medical writers.Key Performance Indicators 1.Preparation of clinical study reports and submission documents in accordance with the KPIs specified by Development with respect to timelines and compliance to internal and external standards.2.Completion of an adequate number of clinical documents (taking into account complexity) per year in accordance with the KPIs specified by Development. 3.Timely assignment of medical writing resource to each trial or submission within the project medical writers programs. 4.Adequate representation of RMW in the International Clinical Team, International Project Team or submission team, and effectiveness of communication and guidance, as assessed by the Global Program/Brand Medical Director and/or Clinical Trial Leader.5.Provision of adequate coaching and/or mentoring to less experienced writers as assessed by the writer(s) being coached or mentored. Minimum requirementsMinimum university life science degree or equivalent. Higher degree desirable1.At least 4 years medical writing experience. 2.Excellent data interpretation and presentation skills.3.Excellent knowledge of clinical documentation and clinical development process. 4.Excellent communication skills5.Good leadership skills within matrix setting 6.Good influencing and negotiating skills7.Good understanding of statistics and document publishing. 8.Experience of coordinating writing activities for regulatory submissions.9.Good knowledge of regulatory requirements. 10.Good presentation skills.11.Ability to coach/mentor other medical writers. 12.Management of external medical writing
Additional Degree: BA (Arts) | B.Com. (Commerce) | B.Pharm. (Pharmacy) | B.Plan. (Planning) | B.Sc. (Science) | BBA/ BBM/ BBS | BCA (Computer Application) | Diploma-Other Diploma | B.Ed. (Education) | BHM (Hotel Management)

Experience: 4-7


Documentation/Medical Writing | Regulatory Affairs
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