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Help bring science to life and join a leading pharmaceutical company to play a key role in delivering impactful research that drives healthcare innovation! Proclinical is seeking an experienced and dynamic Sr Manager to give leadership support in the development and delivery of high-quality clinical and regulatory documents. This role involves collaboration to ensure compliance with global standards, consistency in scientific messaging, and timely documentation to support clinical development and regulatory submissions.
Job Responsibility:
Define and implement medical writing strategies across multiple clinical programs
Collaborate with Regulatory Affairs, Clinical Development, and Safety teams to align submission planning and timelines
Oversee, mentor, and develop medical writing team members and project leads
Oversee outsourced medical writing activities, ensuring quality and timely delivery
Author and review clinical and regulatory documents, ensuring adherence to internal standards and regulatory requirements
Manage multiple projects, balancing timelines, scope, and resources effectively
Contribute to process improvement initiatives, including the development of tools, templates, and workflows
Communicate complex scientific information clearly to diverse audiences and provide constructive feedback to team members
Promote compliance with health, safety, and environmental requirements, ensuring adherence to internal procedures
Requirements:
Background in Life Sciences or related discipline
advanced degree preferred
Expertise in medical writing within pharmaceutical or CRO environments
Experience leading regulatory writing for major submissions (e.g., marketing applications)
Strong understanding of ICH guidelines, GCP, and global regulatory requirements
Proven ability to manage teams and external vendors in a matrixed or global setting
Excellent leadership, organizational, and time-management skills
High standards for data integrity, quality, and compliance
Professional medical writing certification or training is advantageous