Senior ICF Project Manager

📋 Description

• Act as the lead author responsible for drafting and contributing to routine documents, including clinical study reports and study protocols, while summarizing data from clinical trials.

• May conduct research, compose, or edit intricate clinical, scientific, and program-level documents, such as Investigational Brochures (IBs), Investigational New Drug applications (INDs), and Marketing Authorization Applications (MAAs).

• Evaluate routine documents created by junior team members and may offer training and guidance for junior writers and program managers on document preparation, software for document development, document types, regulatory standards, and knowledge of therapeutic areas.

• Ensure adherence to quality processes and requirements for assigned documents. Contribute insights and independently develop best practices, methods, and techniques to achieve optimal outcomes, including various client-specific processes.

• May support program management tasks by identifying and addressing out-of-scope activities. Responsibilities may include developing timelines, budgets, forecasts, and contract modifications.

• Represent the department during project launch meetings, review meetings, and project team discussions.

⛳️ Requirements

• Bachelor's degree in a scientific field or an equivalent and relevant formal academic/vocational qualification; advanced degree preferred.

• Prior experience that equips the candidate with the knowledge, skills, and abilities necessary to perform the role (approximately 5+ years).

• Experience in the pharmaceutical or Contract Research Organization (CRO) industry is preferred.

• Additional certifications in medical writing (AMWA; EMWA; RAC) are a plus.

🏝️ Benefits

• Health insurance

• 401(k) matching

• Paid time off

• Remote work options