Principal Medical Writer

Job Summary:

This position is responsible for the development of clinical documents for submissions to regulatory authorities globally. Works directly with multidisciplinary project team members with the goal of writing scientifically valid, complete, and consistent documents such as clinical study protocols and amendments, clinical study reports (CSRs), Investigator’s Brochures (IBs), clinical Module 2 summary documents, and other regulatory documents. Has broad understanding of clinical research processes and global regulatory document standards. The Principal Medical Writer will oversee the medical writing activities of multiple compounds and will serve as lead writer on major submissions. Demonstrates strong interpersonal and organizational skills and can interpret and describe scientific data. This position reports to the Head of Medical Writing.

Responsibilities:

• Lead, manage, and coordinate all internal and external writing activities associated with the preparation, compilation, and submission of applications to regulatory authorities globally.
• Oversee and manage internal and contract medical writing resources as required to ensure timely completion of assigned projects.
• Develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines, standards and processes, and AMA Medical Writing styles, as applicable, in adherence with study/project timelines and corporate objectives.
• Actively participate in study and/or project team meetings to provide input regarding medical writing deliverables, timelines, and any process(es) needed for the completion of regulatory documents.
• Administrate as appropriate, the receipt, collation, and incorporation of review comments needed for the completion of regulatory documents.
• Lead or participate in defining and writing standard operating procedures and working practices which will allow the effective and efficient preparation of quality.
• Lead or participate in cross-functional process improvement initiatives.
• Mentor more junior medical writing staff.

Minimum Requirements:

• A Bachelor's degree in a life science discipline, with Master's degree in life science discipline preferred.
• At least 6 years writing experience in the biopharmaceutical/CRO industry required.
• Proficient understanding and knowledge of domestic and international regulatory requirements required and knowledge of therapeutic areas in all phases of clinical development desired.
• Proficiency in organizing and communicating clinical information necessary.
• Strong communications, organizational, time management, and project management skills are required.
• Proficient in MS Word. and experience with template systems(eg, StartingPoint).
• Experience with an electronic document management system(eg, MasterControl, Documentum) and use of templates preferred.
• Strong verbal, written, and interpersonal communication skills needed to work effectively in a team environment.