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Senior Medical Writer, Regulatory
2 months ago
About the Role:
We are seeking a highly skilled and experienced Principal Medical Writer, Regulatory to join our Clinical Development team at BioMarin Pharmaceutical Inc. As a key member of our team, you will be responsible for providing medical writing support for clinical development programs, including authoring and editing documents.
Responsibilities:
- Provide medical writing support for clinical development programs, including authoring and editing documents such as protocols, clinical study reports, and regulatory filings.
- Work with cross-functional teams to develop and implement medical writing strategies and plans.
- Manage and coordinate the development of medical writing deliverables, including timelines, resource allocation, and quality control.
- Collaborate with regulatory agencies to ensure compliance with regulatory requirements and guidelines.
- Develop and maintain relationships with internal stakeholders, including clinical development teams, regulatory affairs, and quality assurance.
- Stay up-to-date with industry trends, regulatory requirements, and best practices in medical writing.
Requirements:
- 8+ years of experience in medical writing, with a focus on regulatory affairs.
- Proven track record of delivering high-quality medical writing products on time and within budget.
- Strong understanding of regulatory requirements and guidelines, including ICH, FDA, and EMA regulations.
- Excellent communication and project management skills, with the ability to work effectively in a team environment.
- Strong analytical and problem-solving skills, with the ability to interpret complex data and develop clear, concise writing.
What We Offer:
At BioMarin Pharmaceutical Inc., we offer a dynamic and supportive work environment, with opportunities for professional growth and development. We are committed to attracting and retaining top talent, and offer a competitive compensation and benefits package, including:
- Competitive salary and bonus structure.
- Comprehensive benefits package, including medical, dental, and vision insurance.
- 401(k) retirement plan with company match.
- Flexible work arrangements, including remote work options.
- Professional development opportunities, including training and education programs.
How to Apply:
If you are a motivated and experienced medical writer looking for a new challenge, please submit your application, including your resume and a cover letter, to [insert contact information]. We thank all applicants for their interest; however, only those selected for an interview will be contacted.
