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Medical Writer II

1.00 to 5.00 Years   Delhi   05 Oct, 2020
Seneos Health
Job LocationDelhi
EducationNot Mentioned
SalaryNot Disclosed
IndustryMedical / Healthcare
Functional AreaMedical Transcription
EmploymentTypeFull-time

Job Description

*Scope

  • Work with cross-functional departments e.g. R&D, LOC, medical, regulatory and commercial departments
  • Takes responsibility for preparation of medical information responses to a high standard, working in accordance with guidelines and SOPs
  • Participates in both internal and external project team meetings and liaises directly with the customer on medical information issues, as appropriate and with senior support as needed.
  • Keeps abreast of current data, trends in medical information and/or medical affairs, developments and advances in area of drug development/medical and/or technical writing.
Job Functions This role is meant to support global medical information and medical affairs team. Job holder should support the product related enquiries on all global products across client and the regulatory submissions (primarily disclosures and redactions). Job holder should have expertise in health sciences whose job will be to draft responses to enquiries maintain enquiry database and regularly track the status of enquiry till it is closed.
  • Provides up-to-date, accurate, timely and appropriate written responses to unsolicited inquiries in collaboration consultation with category medical, wherever applicable. This involves literature search skills and therapeutic area knowledge
  • Keep updated with published medical literature relating to the product line/therapeutic area. Develop strategies and initiatives to implement best practices in medical information within GMI to improve medical information services to internal and external customers.
  • Providing evidence based responses to medical enquiries (especially efficacy/safety related queries) in collaboration consultation with category medical, wherever applicable. This involves literature search skills and therapeutic area knowledge
  • Updating existing responses as per label change as and when required
  • Working on different databases simultaneously
  • Maintaining the tracker and updating it on daily basis
  • Preparation of Global Guidance Documents in response to frequent queries
  • Develop documents supporting clinical drug development
  • Defining search strategy, conducting literature searches and literature evaluation and preparing expert reports based on scientific literature evaluation
  • Responsible for complying with client or company procedures for completing deliverables, obtaining reviews, incorporating edits, and working with teams to complete/finalize deliverables
  • Work in clinical trial disclosures for posting protocol and results in internal website and www.clinicaltrial.gov
, *Minimum Required Education And Experience Master s degree /PhD in a life science-related discipline/BDS/MBBS with at least 1-5 years of broad-ranging relevant experience as a medical writer
  • Must have excellent verbal/written communication skills and excellent presentation skills
  • Experience in medical content generation is preferred
  • Excellent interpersonal and conflict resolution skills
  • Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner
  • Ability to assess and prioritize workload
  • Careful attention to detail and accuracy
  • Knowledge/experience with OTC products will be useful

Keyskills :
clinical trialsexpert reportsmedical affairssearch strategytherapeutic areacontent generationconflict resolutionstatements of work sow

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