Covance

Medical Writer

Job Location(s) PH-Manila
Job Number
2020-41128
Job Category
Medical Writing
Position Type
Full-Time

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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