Medical Writer- Aggregate Reporting

2 days ago

Bengaluru, India Theron Solutions Full time

Job Insights:


Our client is seeking an ambitious and energetic Medical Writer for the authoring of aggregate safety reports to join their Safety team


Responsibilities:

  • Responsible for the entire life cycle of the document and accountable for maintaining quality and timeliness, and compliance to internal/client SOPs and regulations.
  • Responsible for end-to-end authoring of complex deliverables - periodic aggregate reports, including PBRERs, DSURs, SUSAR, PADERs/PAERs, ACOs, RMPs, and ad-hoc regulatory and safety reports, send documents for review on a timely manner, liaise with subject specific stakeholders, set up review comments resolution meetings when needed, facilitate QC process, reference linking, ensure documents are submission-ready before facilitating approval and handover of the document.
  • Perform review to validate accuracy and relevance of the data presented in all the documents against the source data or references used in the document.
  • Perform QC review of documents (Data discrepancy/inaccuracy, misinterpretation of data, missing data, improper sentence structuring, inconsistency of data[text/number] within the document, Grammatical errors, typos, inconsistency/non-compliance to client-specific style)
  • Ensure that clinical documents adhere to current global standards, US Food and Drug Administration (FDA), ICH and Good Clinical Practices (GCP) guidelines and are in accordance with electronic publishing standards.


Qualifications:

  • Medical/M. Pharm/Pharm D/Life sciences degree
  • Minimum 2 years’ experience in medical writing or equivalent experience in life sciences domain with experience in End-to-End authoring of periodic aggregate reports, including PBRERs, DSURs, SUSAR, PADERs/PAERs, ACOs, RMPs, and ad-hoc regulatory and safety reports

Must have:

  • Knowledge of regulatory documentation, drug development process and global regulations and guidelines.
  • Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook).
  • Excellent written and verbal communication skills
  • Excellent organizational and time management skills


EOE: Our client is an Equal Opportunity Employer, committed to a workplace free from discrimination and harassment. Employment decisions are based on business needs, job requirements, and individual qualifications without regard to race, color, religion, gender, age, disability, sexual orientation, gender identity, marital status, military service, genetic information, or any other status protected by law.

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