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Lead Medical Writing Director
2 months ago
Position Overview
We are seeking a highly skilled Medical Writer to take on a vital role in the development, composition, and refinement of essential clinical documents that support our medical and regulatory objectives. In this capacity, you will be instrumental in ensuring that all communications are scientifically accurate and consistently articulated across various documentation.
Core Responsibilities
- Employ advanced medical writing expertise to manage the creation of complex clinical and regulatory documents, as well as submission packages.
- Serve as a knowledgeable resource in document planning and writing, guiding teams through the different phases of document development and regulatory submissions.
- Lead strategic initiatives with an emphasis on technical accuracy to align with the organization’s goals.
- Contribute to the enhancement of departmental processes, policies, and procedures, while mentoring junior staff members.
- Provide insights that contribute to the overall strategy and advancement of the Medical Writing department.
Qualifications
- PhD in life sciences or a related discipline.
- Proven experience in the pharmaceutical industry, with a preference for backgrounds in Oncology and Immunology.
- At least 10 years of experience in medical or scientific writing.
- Demonstrated ability in drafting protocols, clinical study reports, and clinical components for regulatory submissions.
- Comprehensive understanding of regulatory standards, Good Clinical Practice, and drug development processes.
- Experience with document preparation tools and regulatory requirements.
- Strong collaborative skills to work effectively within cross-functional teams.
- Excellent interpersonal skills and a strong sense of ownership in responsibilities.
- Opportunity for hybrid work arrangements.
