The Pre-submissions Project Manager will be embedded within the vaccines team at a leading
pharmaceutical company. The nature of this work may involve extended hours or periodic
weekends when pre-submissions are due with tight deadlines (only about 5% of the time).
The Project Manager will manage the quality control and preparation of marketing materials for
submission to the FDA. Track marketing materials throughout the review and approval process
until they are approved. Coordinate with job owners and agencies to review final versions of their
submission materials ensuring adherence to FDA submission regulations. Provide editorial and
QA assistance for accuracy in formatting. Communicate and review required changes with all
partners prior to final submittal to the FDA.
Other responsibilities include:
Interface with the company vaccines group to ensure that all sub-part E advanced approval
indication submissions reach the FDA submissions in a timely manner, while maintaining
required standards and quality.
Attend the weekly pre-submissions priority call; maintaining pre-submission scheduling
standards and coordinating workload.
Improves quality control through communication and partnership with OPAR and agencies.
Creating standards and procedures to maintain consistency.
Collaborates daily with multiple internal and external partners to ensure that projects are
prioritized and processed according to brand and FDA standards.
Continue to partner and train agencies to control quality and reduce recertification rates as
standards and processes evolve.
Skills and experience needed:
Bachelor's degree in a related field or equivalent experience
Veeva PromoMats experience highly desired
2-3 years' experience in content review/ quality assurance preferred
Demonstrated familiarity with references and editorial standards, communication standards,
and classification systems
Project Management experience required
Ability to work independently, as well as, in a collaborative environment.
Excellent customer service skills with strong verbal and written communication skills
Solid technology background including Microsoft Office Suite software and Adobe Acrobat,
and familiarity with trends in delivery of electronic information
Experience working in a regulated industry preferred
Editorial skills and attention to detail desired
Prior experience working with tight deadlines
Demonstrated ability to be flexible and able to work in a fast-paced environment
Process oriented, with an eye for quality control and process improvements
Compensation Range: $70-75k
The range provided is our reasonable estimate of the compensation for this role. The actual amount may be higher or lower, based on factors such as experience, knowledge, skills, abilities and location.
Our eligible talent gets access to amazing benefits like subsidized health, vision, and dental plans, paid sick leave, and retirement plans with a match. We also offer free online training through AquentGymnasium.
Client Description
Aquent Studios is a global creative studio that delivers scale, speed and efficiency to the world's most recognized brands. We create the work that matters the most to them-work that has a real impact on their business. As an Aquent Studio team member, you'll have the opportunity to engage with the largest and most influential companies in the world, solving design challenges and extending their brands across tactic types and platforms, including digital design, UI/UX, video, motion, content, print design, web development, and more. If you want to do work that matters in a collaborative setting that values ingenuity and personal growth, you have found the right place!
