Medical Writer – Pasig City – Sciformix Philippines

Job Description / Requirements
Perform various writing activities in the area of drug safety and drug development
Strong working knowledge of anatomy, physiology, disease states, medical treatments and procedures, medication names and drug therapy
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
Write parts of various safety reports for global regulatory submissions, including Annual Reports, Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Bridging reports
Assist in writing Investigator brochures and sections of protocols
Assist in writing Clinical Study Reports for Ph 1-4 trials, including full study reports, abbreviated reports, web synopses
Assist pharmacovigilance teams in writing narratives for the adverse drug reactions and adverse events they process

Experience in Clinical Research
Experience in Pharmacovigilance
Experience in Medical Writing
Candidates who can start ASAP will be prioritized
Good understanding of regulatory requirements and ICH-GCP guidelines
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
Proficient in Microsoft Office applications
Candidate must possess at least a Bachelor’s/College Degree, Professional License (Passed Board/Bar/Professional License Exam), Nursing, Pharmacy/Pharmacology, Medicine or equivalent
At least 2 year(s) of working experience in the related field is required for this position
Minimum of 2 years experience in Medical Writing with PSUR experience.
10 Full-Time position(s) available

How to Apply
Interested applicants may email their most recent CV to