Type of Position:
6-month, on-site contract
Responsibilities:
Actively coordinate and participate in the production of periodic and ad hoc DS medical and regulatory reports including, but not limited to, safety sections of Clinical Study
Reports and health authority submissions, periodic safety update reports, and issue work-ups.
This includes writing, editing, and coordinating production of adverse event narratives and safety-related documents.
Create and maintain departmental and safety-related document templates and controlled documents as needed.
Proactively review and understand molecules and protocols (where applicable) that are associated with specific writing projects to facilitate efficient and effective handling of data and document structure
Effectively communicate new developments within the regulatory writing field to internal and external groups (e.g., Regulatory, Clinical Science, etc.) to ensure overall alignment with industry standards
Participate in committees, departmental initiatives, clinical team filing activities, and special projects in collaboration with DS management
Effectively interact on multiple projects working independently as well as within intra- and inter-department functional teams
Maintain effective communication with and influence all levels throughout a highly matrixed organization, and builds successful working relationships across disciplines
Requirements:
Excellent verbal and written communication skills, organizational skills, and time and resource management skills.
Able to partner effectively with internal and external partners in a proactive, positive and constructive manner
Able to manage multiple projects and timelines, and accommodate multiple priorities in a fast paced and changing environment.
Organized and detail oriented, demonstrates a high level of commitment and drive for excellence, and generates enthusiasm
Strong collaboration, communication and leadership skills to effectively and clearly coordinate across multiple functional areas with a diverse group of team members
Bachelor's degree in Science or Business-related field; clinical education and experience preferred.
Minimum 5 years of medical writing or equivalent experience.
Highly skilled in Microsoft Office applications, Adobe Acrobat, PowerPoint, and other relevant applications for writing, editing, development of controlled documents, etc.
Knowledge of biotechnology/pharmaceutical industry, the clinical drug development process, and drug safety preferred.
Knowledge of regulatory requirements and ICH Guidelines as related to regulatory writing.