Medical Writer
covance
Manila, Philippines
1d ago

Job Overview :

  • Efficiency in conducting literature searches for authoring various types of reports
  • Author / 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 Adverse Drug Experience Reports, Periodic Benefit-Risk Evaluation Reports, Bridging reports and other clinical documents as assigned.
  • Perform / review Signal detection activities
  • Author / review RMP, ad hoc reports, Safety Update reports, Benefit-Risk Evaluation, CCDS supporting document, ACOs, Addendum reports
  • Perform allied activities like : Generation of linelistings and summary tabulation, CFIs CFCs
  • Write Common Technical Document Summaries including Non Clinical and Clinical Overviews, Clinical Summaries and other regulatory documents as assigned.
  • Author Investigator Brochures and sections of / entire protocols, Informed Consent Forms (ICFs), Case Report Forms (CRFs)
  • Write Clinical Study Reports (in whole or in part) for Ph 1-4 trials, including full study reports, abbreviated reports, web synopses
  • Author / review manuscripts, abstracts, posters for conferences
  • Prepare medical information responses for HCPs
  • Write subject narratives for adverse drug reactions and serious adverse events
  • Internal and external (client) communication & co-ordination to get the required inputs
  • Create and update 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 prepare supporting / justification document
  • Author / review SOPs / WIs / process documents or sections as applicable
  • Impart / conduct Trainings for peers and team members
  • Any additional activities as per the project requirement or manager’s discretion on completion of relevant trainings
  • Education / Qualifications :

    Master’s degree in Pharmacy / related science area

    Bachelor’s degree in Medical Science

    At least 3 years of experience in the pharmaceutical industry, with at least 2 years of

    it in medical writing

    Experience :

    HCP with 2-4 years of experience in Medical Writing / PV industry with experience in ophthalmology is preferred

    Drug discovery and development

    Clinical Research, Pharmacovigilance

    Good understanding of regulatory requirements and ICH-GCP, GLP guidelines

    Technical proficiency with Microsoft Office suite applications

    Clinical and Pre-Clinical Research, Good Clinical Practice, Good Laboratory

    Practice

    Strong working knowledge of anatomy, physiology, disease states, medical

    treatments and procedures

    In-depth knowledge of medication names and drug therapy

    Thorough understanding of drug safety and management of benefit / risk assessment

    Orientation to pharmacokinetic, pharmacodynamic and toxicology principles

    Strong written and verbal language skills

    Ability to analyze and synthesize medical information

    Basic understanding of statistical concepts

    Concern for quality, detail orientation

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