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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in medical writing, including the creation and editing of complex deliverables such as Clinical Study Reports and Informed Consent Forms, while ensuring regulatory compliance and high scientific quality. Proficient in coordinating cross-functional teams and mentoring junior writers to achieve project goals.
Highest-signal resume keywords
Medical WritingClinical Study ReportsInformed Consent FormsProject ManagementRegulatory Compliance
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Medical WritingClinical Study ReportsInformed Consent FormsClinical Evaluation ReportsCTD SubmissionsProtocols WritingData Accuracy ReviewFormatting StandardsScientific Quality ControlRegulatory Affairs
Soft Skills
Coordination SkillsMentoringNegotiation
Industry Keywords
Life SciencesCROsBiostatisticsData ManagementPV
About the role
Key responsibilities & impact- To write and edit complex medical writing deliverables (including informed consent forms, clinical study reports, clinical evaluation reports, CTD submissions) in accordance with sponsors’ and Excelya’s SOPs, guidelines and applicable legislation.
- To coordinate cross-functional stakeholders and departments (including Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, PV) to ensure the timely collection, review, alignment, and integration of scientific and clinical content required for the development of high-quality medical writing deliverables (including clinical study protocols, IBs, INDs).
- To ensure the accuracy, consistency and regulatory compliance of all information, data and references included in the produced publications/documents, maintaining high standards of scientific quality.
- To contribute to document quality control (reviewing data accuracy, formatting, appropriateness of language and compliance with industry guidelines).
- To mentor and lead less experienced Medical Writers on complex projects, and to support the Principal Medical Writer with the coordination of other Medical Writers or Senior Medical Writers.
- To liaise with sponsors to negotiate changes where necessary and ensure alignment on deliverables and expectations.
Requirements
What you’ll need- Degree in Life Sciences.
- At least 3 years of experience in medical writing.
- Experience with writing of protocols, CSRs and CTDs.
- Fluent in English.
- Previous experience in CROs is a plus.
- Project management and coordination skills.
Benefits
Comp & perks- Why Choose Excelya?
- At Excelya, we lead with Audacity, act with Care, and move with Energy. We nurture your potential through high-impact projects, give your talents the space to shine, and push boundaries to elevate every patient’s journey. Here, you're not just doing a job—you’re becoming a key part of something bigger.
- So, if you're ready to excel with purpose, let’s write the next chapter together.
