Job Description

We seek an ambitious and energetic Medical Writer for authoring of aggregate safety reports to join our Safety team The successful candidate will be responsible for authoring/performing QC/review of safety documents. 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 simple to medium 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 peer 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). 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. Assist senior medical writers in authoring complex deliverable types. 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. Volunteer in training programmes to develop skills in areas relevant to the job in addition to the areas of interest. Interface with clients on a regular basis to meet their expectations. 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. About you: 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: Good knowledge of document management systems and other relevant applications (eg Excel, Outlook). Good knowledge of regulatory documentation and drug development process and templates. Excellent written and verbal communication skills. Excellent organizational and time management skills. Excellent data interpretation and presentation skills. Nice to have: Strong interpersonal skills and the ability to be flexible in varying environments Cognitive abilities including; verbal reasoning, attention to detail, critical thinking, and analytical ability

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