Job Summary (Primary function)
The Senior Medical Writer is responsible for the development of clinical documents for worldwide submissions to regulatory authorities. Works directly with multidisciplinary project team members with the goal of
independently writing scientifically valid, complete, and consistent documents, such as clinical study reports (CSRs), investigator's brochures (IBs), and collaborating on clinical summary documents. Demonstrates strong interpersonal and organizational skills and can interpret and describe results. Responsible for the medical writing activities for one or more compounds. Understands the 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 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.
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.
By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.
