This position is responsible for the preparation of clinical documents for worldwide submissions to regulatory authorities. 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), Investigators Brochures (IBs), clinical Module 2 summary documents, Clinical Development Plans, and other regulatory documents. Has broad understanding of clinical research processes and global regulatory document standards. Demonstrates understanding of intermediate biostatistical methods and can interpret and describe results. This individual may serve as lead writer on major submissions. This position reports to the Head of Medical Writing.
- Lead, manage, and coordinate all internal and external writing activities associated with the preparation, compilation, and submission of applications to worldwide regulatory authorities.
- Oversee and manage internal and contract medical writing resources as required to ensure timely completion of assigned projects.
- Prepare regulatory documents for the purpose of submission to regulatory agencies, IRB/Ethics Committees, and other relevant parties, in accordance with ICH and GCP guidelines, standards, and processes and AMA Medical Writing styles, as applicable, in adherence with study/project timelines and objectives.
- Actively participate in study and/or project team meetings to provide input regarding 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.
- Assist in defining and writing standard operating procedures and working practices which will allow the effective and efficient preparation of quality documents in accordance with stated objectives and timelines
- 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) is desirable.
- Strong verbal, written, and interpersonal communication skills needed to work effectively in a team environment.