senior Medical writerLaboratory Corporation of America

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
Laboratory Corporation of America

Manila City, Metro Manila
Permanent
Full-time