CSR Narrative Writer (Pharma)

TL;DR

CSR Narrative Writer (Pharma): Writing safety documents and patient CSR narratives for regulatory submissions with an accent on ICH compliance and high-quality documentation. Focus on managing complex narrative projects, addressing client feedback, and ensuring accuracy in clinical trial reporting.

Location: Must be based in the Philippines and available for US EST shift.

Company

hirify.global is an innovative, data-focused CRO supporting the pharmaceutical, biotech, and medical device industries with scientific approaches to complex trial data and regulatory submissions.

What you will do

• Write safety documents and patient CSR narratives for regulatory agency submissions.
• Manage document lifecycles, including revisions and addressing client comments.
• Ensure all deliverables comply with ICH and regulatory guidelines.
• Interact directly and independently with clients to manage project expectations.
• Review deliverables with limited mentor oversight prior to client release.
• Practice leadership skills in both internal and external customer service contexts.

Requirements

• Must be based in the Philippines and able to work US EST shift.
• Minimum 2 years of experience in a regulated scientific, clinical, pharmaceutical, or biotech environment.
• University degree in a scientific, medical, or clinical discipline.
• Strong understanding of ICH guidelines applicable to medical writing.
• Proficiency in Microsoft Word and Adobe Acrobat.
• Excellent written English skills.

Nice to have

• Experience leading complex CSR narrative projects.
• Background in Oncology.
• Master’s or PhD in a scientific, medical, or clinical discipline.
• Experience with Electronic Document Management systems.

Culture & Benefits

• Opportunity to work with a leading global CRO with a 97 percent customer satisfaction rating.
• Exposure to complex drug development and regulatory submission processes.
• Professional growth within a data-driven, scientific environment.