Medical Writer II needed with strong clinical and regulatory experience

Summary of Position

The Drug Safety (DS) Medical Writer II is responsible for coordinating and participating in the production of DS medical, regulatory, and other controlled documents in the DS department.

Job 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, Development Editing) to ensure overall compliance 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 influences all levels throughout a highly matrixed organization, and builds successful working relationships across disciplines.

Education, Experience & Other 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

• Bachelors degree in Science or Business-related field; clinical education and experience preferred.

• Minimum five 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.

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