
Senior Scientific Medical Writer
1 day ago
Our medical writing team is seeking a highly skilled and experienced medical writer to join our ranks. The ideal candidate will have a strong background in scientific writing, with experience in regulatory medical writing for the pharmaceutical industry.
- Key Responsibilities:
- Write high-quality, compliant clinical study reports, study protocols, informed consent forms, and other regulatory documents;
- Develop project timelines, standards, budgets, forecasts, and contract modifications;
- Collaborate with internal teams, including project management, clinical, QA, data management, biostatistics, and regulatory;
- Escalate out-of-scope project activities and propose solutions;
- Represent the department as a primary contact on projects, including project launch meetings, review meetings, client audits, bid defenses, and capabilities presentations;
- Bachelor's degree in a scientific discipline or equivalent qualification;
- Minimum 2-5 years of experience in medical writing or a related field;
- Advanced degree preferred;
- Experience working in the pharmaceutical/CRO industry preferred;
- Additional qualifications in medical writing (AMWA; EMWA; BELS; RAC) advantageous;
- Significant knowledge of global, regional, national, and other document development guidelines;
- In-depth knowledge in a specialty area such as therapeutic, regulatory submissions, healthcare communications, etc.
- Excellent written English skills, with ability to produce well-organized, error-free documents;
- Aptitude to accurately work with numerical information and data;
- Ability to analyze complex issues and evidence, identify information gaps, and generate effective solutions;
- Sound professional judgment in analyzing and responding to enquiries, issues, and escalations;
- Facilitate conflict resolution among team members and clients.
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