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This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Principal Medical Writer. In this role, you will take the lead in crafting high-quality regulatory and clinical documents that communicate complex scientific and medical information clearly. Your expertise will directly support client submissions to regulatory authorities, ensuring compliance and enhancing the quality of clinical development. As a key player, you will collaborate with a diverse team, driving innovation and excellence in the industry. This position offers opportunities for professional growth and the chance to influence the future of clinical research.
Accountabilities
- Lead the preparation and review of clinical study reports, protocols, and other regulatory documents to ensure accuracy and clarity.
- Perform medical writing tasks of high complexity and critical importance to ongoing projects.
- Develop clinical trial reports (CTRs) and lay summaries of clinical trial results.
- Create investigator brochures (IBs), clinical evaluation plans (CEP), and clinical evaluation reports (CER).
- Draft pediatric investigational plans (PIPs) and comprehensive regulatory submission documents.
- Collaborate with cross-functional teams to gather and synthesize information for document development.
- Provide guidance on best practices for medical writing, ensuring adherence to regulatory requirements.
Requirements
- Advanced degree in life sciences, medicine, or a related field; relevant certifications preferred.
- Minimum 5 years of experience as a regulatory medical writer.
- Significant experience in medical writing, especially for regulatory submissions.
- Strong understanding of regulatory requirements and industry standards.
- Exceptional writing and editing skills with a keen eye for detail.
- Excellent communication and interpersonal skills for effective collaboration.
- A commitment to maintaining high standards of quality and compliance.
Benefits
- Competitive salary and diverse culture that rewards high performance.
- Various annual leave entitlements.
- Range of health insurance offerings tailored to your needs.
- Competitive retirement planning offerings to maximize savings.
- Access to a global Employee Assistance Programme.
- Life assurance and flexible optional benefits.
- Opportunities for ongoing learning and career development.
Why Apply Through Jobgether?
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.
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We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
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