Job Summary (Primary function)
The Associate Director, Principal Medical Writer II is responsible for the development of clinical documents for submissions to regulatory authorities globally. Provides strategic direction to cross-functional project teams with minimal oversight to ensure that clinical documents (eg, Investigators' Brochures [IBs], Clinical Study Reports [CSRs], and marketing authorization submission documents) accurately and consistently present key data-driven clinical messages in accordance with program goals and regulatory requirements. Writes or provides direction and leadership to other writers to ensure the timely delivery of high quality documents that are scientifically rigorous, logically organized, and have accurate data presentation and interpretation. Oversees the medical writing activities of multiple compounds and serves as lead writer for individual summary documents. Has a broad understanding of clinical research processes and global regulatory document standards. Mentors less experienced writers. Reports to a Director of Medical Writing or above.
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 authoring standards, as applicable, in adherence with study/project timelines and corporate objectives.
▪ Lead, manage, and coordinate all internal and external clinical medical writing activities associated with the preparation, compilation, and submission of applications to regulatory authorities globally for the assigned programs/compounds.
▪ Participate in cross-functional meetings to provide input regarding medical writing deliverables, timelines, and any process(es) needed for the completion of regulatory documents.
▪ Review other documents associated with the assigned project(s) (eg, Protocols and Statistical Analysis Plans), as appropriate.
▪ Lead or participate in cross-functional process improvement initiatives.
▪ Lead or participate in defining and writing standard operating procedures and best practices for an efficient preparation of quality documents.
Mentors more junior medical writing staff.
Qualifications (Minimal acceptable level of education, work experience, and competency)
▪ Bachelor's degree required. Advanced degree in a relevant scientific/clinical/regulatory field preferred.
▪ At least 7 years medical writing experience in the biopharmaceutical/CRO industry required or comparable experience within clinical or preclinical development.
▪ Demonstrated ability to understand and interpret clinical and scientific data with minimal oversight; ability to define data presentation to meet key messages developed by the clinical team.
▪ Excellent project management skills including in depth understanding of clinical timelines (study and submission level) and working knowledge of roles of other functional areas and the interdependencies among groups.
▪ Strong verbal, written, and interpersonal communication skills needed to work effectively in a team environment.
▪ Proficient understanding and knowledge of global regulatory requirements is needed and knowledge of therapeutic areas in all phases of clinical development desired.
▪ Demonstrated ability to independently lead the development, review, and approval of clinical documents and the ability to identify any new or unique document types that may require a different approach.
▪ Proficient in MS Word. Experience with an electronic document management system and templates is required.
▪ Ability to interact effectively with team members/leaders and senior leaders at proactively facilitating effective information exchange/communication (including problem solving and issue
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.
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