Job Summary (Primary function)
Essential Functions of the Job (Key responsibilities)
- Develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines, standards and processes, and Company authoring standards, as applicable, in adherence with study/project timelines and corporate objectives.
- Manage medical writing projects, including developing timelines (working with the study/project teams, as necessary) and communication with cross-functional team members to maintain awareness of review cycles and expectations.
- Administer as appropriate the receipt, collation, and incorporation of review comments needed for the completion of regulatory documents
- Participate in cross-functional meetings to provide input regarding medical writing deliverables, timelines and any processes needed for the completion of regulatory documents.
- Review other documents associated with the assigned project(s) (eg. Protocols and Statistical AnalysesPlans), as appropriate
- May participate in cross-functional process improvement initiatives.
- Assist in defining and writing standard operating procedures and working practices to allow the effective and efficient preparation of quality documents.
Qualifications (Minimal acceptable level of education, work experience, and competency)
- Bachelor's degree required or equivalent experience. Advanced degree in a relevant scientific/clinical/regulatory field preferred.
- Proficient in MS Word. Experience with an electronic document management system and templates is preferred
- Understanding of global regulatory requirements is needed and knowledge of therapeutic areas in all phases of clinical development preferred.
- Strong verbal, written, and interpersonal communication skills needed to work effectively in a collaborative environment.
- Proficiency in organizing and communicating clinical information required with minimal oversight.
- Strong organizational, time management, and project management skills are required.
- Medical writing experience in the biopharmaceutical/CRO industry required or comparable experience within clinical or preclinical development.
- Strong verbal, written, and interpersonal communication skills needed to work effectively in a team environment.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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