Covance

Senior Medical Writer

Job Location(s) PH-Manila
Job Number
2020-41129
Job Category
Drug Safety/Pharmacovigilance
Position Type
Full-Time

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 Adverse Drug Experience Reports, Periodic Benefit-Risk Evaluation Reports, Bridging reports and other clinical documents, as assigned.
 Perform/review Signal detection activities
 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 Adverse Drug Experience Reports, Periodic Benefit-Risk Evaluation Reports, Bridging reports and other clinical documents, as assigned.
 Perform/review Signal detection activities
 Author/ review RMPs, ad hoc reports, Safety Update reports, Benefit-Risk
JOB DESCRIPTION FORM
(Form SC-HR09B_v0)
SC-HR09B Job Description Form Version 0, Dated 03-Nov-2014
Company Confidential Page 2 of 2
Evaluation, CCDS supporting document, ACOs, Addendum reports
 Write Common Technical Document Summaries including Non Clinical and Clinical Overviews, Clinical Summaries and other regulatory documents as assigned.
 Author/Review Investigator Brochures, Protocols, Informed Consent Forms (ICFs), and Case Report Forms (CRFs)
 Author/review Clinical Study Reports for Ph 1-4 trials, including full study reports, abbreviated reports, web synopses, subject narratives
 Author/review manuscripts, abstracts, posters for conferences
 Prepare medical information responses for HCPs
 Act as a writing coach, devise training programs
 Author/review SOPs/WIs/process documents or sections as applicable
 Impart/conduct Trainings for peers and team members
 Coordinate activities related to various types of report writing across a team of writers if applicable
 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
 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
 Any additional activities as per the

Education/Qualifications

 Master’s degree in Pharmacy/related science area OR Bachelor’s degree in Medical
Science

Experience

 HCP with 2-4 years of experience in Medical Writing/PV industry with experience in ophthalmology
 At least 5 years’ experience in the pharmaceutical industry, with at least 3 years of it in
medical writing
 Experience in Pharmacovigilance is desirable
 Clinical Research, Good Clinical Practice
 Strong working knowledge of anatomy, physiology, disease states, medical treatments
and procedures, medication names and drug therapy
 Thorough understanding of drug safety
 Orientation to pharmacokinetic and pharmacodynamic principles
 Strong written and verbal language skills
 Ability to analyze and synthesize medical information
 Basic understanding of statistical concepts
 Concern for quality, detail orientation
 Coaching and mentoring

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