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Bachelor's degree in science, health profession, or journalism required.
At least 5 years experience writing for pharma or biotechnology required. 3+ years of electronic documents and submissions required.
Experience as lead writer for key documents included in major US and/or international regulatory submissions required
Experience managing writing activities for a major US or international regulatory submission (project or people management) preferred.
Clear understanding of clinical development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission and support for marketed products.
Understanding of FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to document preparation and production (including CTDs).
Ability to understand Takeda guidelines and requirements related to the preparation and production of regulatory documents and submissions.
Well-developed oral and written communication skills; ability to clearly present technical information within and across functional areas.
Demonstrated problem-solving and interpersonal skills that facilitate effective interactions within functional and cross-functional teams and with external providers.
Knowledge of team dynamics and ability to function as a team leader.
Intellectt INC
