Medical Writer

1 week ago

Hyderabad, Telangana, India Spectrum Talent Management Full time
Job Description

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).
- Assist junior writers with incorporation of review comments, tracking and communication. Assist and mentor colleagues on the scientific formats required to prepare the documents, to ensure consistency and completeness of the report, provide guidance and support with regard to format, style, content, and compliance.
- Review formatting per the client -specific style guide and format PDF documents in Adobe Acrobat and ISI Toolbox which includes review of TOC, list of abbreviations, formatting of tables and figures for consistency in font, alignment, foot note references, portrait and landscape adjustments, etc; endnotes, cross referencing, pagination, bookmarking and hyper-linking.
- Responsible for continuous process improvement in the team for developing content.
- 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.
- Responsible to participate in assigned training programmes relevant to the job.
- Create, maintain and disseminate training materials and guidelines and conduct training seminars as necessary.
- Control/reduce effort, cycle time and error rates in projects.
- Work and interact extensively with clinical and regulatory experts, as well as external contacts to ensure high quality with regard to scientific content, organization, clarity, accuracy, format and adherence to regulatory and internal guidelines, styles and processes.
- Provide peer review for colleagues in support of all documents.
- Interface with clients on a regular basis to meet their expectations.
- Orientation Compliance to quality, confidentiality and security.
- Adhere and follow quality systems, processes and policies.
- Comply to training and specifications.

Qualifications:

- Medical/M.Pharm/Pharm D/life sciences degree.

Education:

- 5-7 years of relevant experience

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