Neurodiversity Advisors Inc. Jobs

Mobile Neurodiversity Advisors Logo

Job Information

Labcorp Lead Medical Writer in Argentina

Job Overview:

  • Implement and promote use of consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures, and assume accountability for the deliverables

  • Ensure compliance of operations with governing regulatory requirements

  • Create, maintain and assume accountability for a culture of high customer service

  • Efficiency in conducting literature searches for authoring various types of reports

  • Write and review various safety reports (or part of such reports) for global regulatory submissions for Sciformix’s clients, including Annual Reports (IND and other), Periodic Safety Update Reports/ Periodic Benefit Risk Evaluation Reports, Periodic Adverse Drug Experience Reports, Bridging reports and other clinical documents as assigned.

  • Write Common Technical Document Summaries including Non Clinical and Clinical Overviews, Clinical Summaries and other regulatory documents as assigned..

  • Write Investigator Brochures and sections of/entire protocols

  • Write Clinical Study Reports (in whole or in part) for Phases 1-4 trials, including full study reports, abbreviated reports, web synopses, subject narratives

  • Author Informed Consent Forms (ICFs), manuscripts, abstracts, posters for conferences.

  • Resolve and/or escalate issues in a timely manner

  • Timely escalation of unresolved issues to internal and external (client) point of contact

  • Support and contribute to onboarding, training, mentoring, and coaching of new associates

  • Prepare medical information responses for HCPs

  • Act as a writing coach

  • Coordinate activities related to various types of report writing across a team of writers if applicable

  • Liaise with client and act as a primary point of contact for all report writing activities

  • Perform various support activities such as tracking, maintenance of metrics, performing and documenting quality checks and training

  • Assist in estimation of resource requirement and responding to RFPs as needed

  • Internal and external (client) communication & co-ordination to get the required inputs

  • Get resolution on issues affecting project deliverables

  • Creating and updating labels, , e.g. Core Data Sheets, USPI, centralized SPC’s, Med Guides

  • Search literature databases for relevant information, recommend label changes, author proposed label text and preparation of supporting/justification document

Education/Qualifications:

  • Master’s degree in Pharmacy/related science area

  • Bachelor’s degree in Medical Science

  • At least 5-7 years’ experience in the pharmaceutical industry, with at least 4 years of it in medical writing

  • Experience in drug discovery and pharmacovigilance is desirable

Experience:

  • At least 5-7 years’ experience in the pharmaceutical industry, with at least 4 years of it in medical writing

  • Experience in drug discovery and pharmacovigilance is desirable

  • Fluent English

DirectEmployers