Covance

Senior Medical Writer

Job Location(s) PH-Manila
Job Number
2021-75692
Job Category
Drug Safety/Pharmacovigilance
Position Type
Full-Time
Telecommute
No

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
- Author/ review RMPs, ad hoc reports, Safety Update reports, Benefit-Risk 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 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 5 years’ experience in the pharmaceutical industry, with at least 3 years of it in medical writing
- Experience in drug discovery and pharmacovigilance is desirable

Experience

- 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
- Coaching and mentoring of other team members

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