Medical Writer

Job Description

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. "Degree in Medical/M.Pharm/Pharm D/Life Sciences. Strong experience in safety reports (PBRERs, DSURs, SUSAR, PADERs, RMPs), QC/review, document lifecycle management, client interactions, and compliance with FDA, ICH, and GCP guidelines. Expertise in formatting using Adobe Acrobat and ISI Toolbox. Mentoring and peer reviewing skills.5–7 yrs of hands-on experience in authoring & reviewing safety reports (PBRERs, DSURs, SUSARs, RMPs, etc.) Proven expertise in QC & data accuracy validation against source data, including formatting (Adobe Acrobat, ISI Toolbox) Strong understanding of FDA, ICH, and GCP guidelines, with experience ensuring regulatory compliance Solid mentoring and peer review experience, with the ability to guide junior writers and handle client communication" Job Type: Full-time Pay: ₹500,000.00 - ₹1,000,000.00 per year Application Question(s): Do you have a degree in Medical, M.Pharm, Pharm D, or Life Sciences? Do you have 5-7 years of hands-on experience authoring and reviewing safety reports (PBRERs, DSURs, SUSARs, RMPs)? Are you proficient in formatting using Adobe Acrobat and ISI Toolbox? Do you have experience ensuring compliance with FDA, ICH, and GCP guidelines? Have you mentored junior writers and handled direct client communications in previous roles? Please select the location(s) the candidate is comfortable working from: * Bangalore Mumbai Hyderabad Pune Delhi NCR How soon can you join? Work Location: In person