Sr. Medical Writer

2 weeks ago

Manila, National Capital Region, Philippines CLINCHOICE, INC. Full time

About us

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services. With over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific, we are positioned to fulfil our clients' business requirements locally and globally. We offer high-quality, full-service clinical development and post-marketing solutions. For our clients, it means a reliable partner and quality results.

Qualifications & experience

• Bachelor's degree in science or above and in alignment with project / business team requirements• Minimum of 3 to 5 years years of relevant experience in identified functional domain/ business workstream.Tasks & responsibilities• Assists in developing and review of clinical study documents: clinical study reports (CSR), study protocols/synopses, informed consent (IC), investigator's brochure (IB), safety management plan, and safety reports (PBRERs, DSURs, PADERS, etc.)• Conducts literature scans/searches and review for summaries and reports• Proactively incorporates team input and comments into edits and revisions.• Performs and completes quality review and verification vs source data.• Completes project/workstream/ClinChoice specific work instructions (WI), process guidelines, SOP trainings as per identified schedule.• Contributes knowledge on diverse topics within the Medical Device arena.• Streamlines the clinical research writing approach to ensure that clinical and epidemiologic data are presented coherently

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