Key skills
- Scientific and medical writing with strong command of clinical terminology
- Regulatory document preparation (IND, NDA, BLA submissions)
- Research analysis and literature review synthesis
- Ability to translate complex data into clear, compliant documentation
- Proficiency with medical writing software and content management systems
- Project management and cross-functional collaboration with R&D and compliance teams
- Attention to detail with strong editing and proofreading capabilities
Frequently asked questions
What does a Medical Writer do on a daily basis?
Medical Writers develop and produce technical documentation for pharmaceutical, biotech, and healthcare organizations. Daily responsibilities include drafting clinical study reports, regulatory submissions, safety summaries, and scientific publications. They research clinical data, analyze study findings, collaborate with scientists and regulatory specialists, review feedback, and revise documents to meet strict compliance standards. Medical Writers also manage timelines, maintain documentation standards, and ensure all materials meet FDA and international regulatory requirements.
What certifications or qualifications are required for a Medical Writer?
Most Medical Writer positions require a bachelor's degree in life sciences, chemistry, pharmacy, or related field. Many employers prefer candidates with advanced degrees (MS or PhD) or specialized certifications such as AMWA (American Medical Writers Association) credentials. Candidates should have 2-5+ years of experience in clinical documentation, pharmaceutical writing, or biotech environments. Familiarity with FDA regulations (21 CFR Part 11) and ICH guidelines is highly valuable. Experience with therapeutic areas, clinical trial knowledge, and regulatory pathway understanding are strong differentiators.
How does hiring a Medical Writer through ECLARO work?
ECLARO matches your organization with qualified Medical Writers based on your specific project needs, therapeutic area, and regulatory requirements. Whether you need a contract writer for a specific submission, a full-time staff addition, or project-based support, ECLARO manages the entire recruitment and onboarding process. We handle candidate screening, credential verification, and compliance checks, allowing you to focus on your core operations. Our Medical Writers integrate quickly into your teams and are familiar with standard pharmaceutical development workflows and documentation practices.
What therapeutic areas and document types do Medical Writers at ECLARO support?
ECLARO places Medical Writers across all therapeutic areas including oncology, cardiovascular, infectious disease, rare disease, and medical devices. They produce a range of deliverables: regulatory submissions (INDs, NDAs, BLAs, CTAs), clinical study reports, safety updates, protocol summaries, patient-friendly materials, and scientific publications. Many of our Medical Writers have specialized expertise in specific document types or therapeutic areas, allowing us to match the right talent to your project requirements and timelines.
Ways to hire through ECLARO
ECLARO can fill this role through contract or contract-to-hire staffing, direct placement, an Employer of Record (EOR), recruitment process outsourcing (RPO), or a dedicated offshore team in the Philippines (ECAPTIVE).