Senior Manager, Regulatory and Medical Writing (Remote - US)

Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is an award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work® Certified organization, recognized for our exceptional culture and industry-leading employee retention. We support the pharmaceutical, biotech, and medical device industries with our proven scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join MMS and be part of a team that is shaping the future of clinical research. Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit www.mmsholdings.com or follow MMS on LinkedIn. Job Specific Skills Maintains a strong understanding of regulations and guidance as they pertain to medical writing; mentors others; advises on MMS updates related to regulatory updatesExpert on styles of writing for various document types, including more complex document types; mentors others; document SMEProficient with QC, MW tools, training, and processes; provides mentorship to others, SMEUtilizes and trains others on technologies such as AI-assisted authoring technologies where ableProficient on resolving complex issues where analysis of situations or data requires an in-depth knowledge of organizational objectivesImplements strategic policies when selecting methods, techniques, and evaluation criteria for obtaining resultsProvides immediate supervision to their team, assigning tasks, checking work at regular intervals. Also takes on SME roles and other departmental leadership, including leading important initiatives. Mentor's managers (Associate and I/II levels); identifies leadership roles for their reportsExperienced in understanding impact of updates in related deliverablesCompetent with managing client meetings and CRMsIndependently manages a project from start to finishProficient with identifying and mitigating project risk, including assessing client gapsAdept at handling client feedback with appropriate follow-up or resolution Job Requirements College graduate in scientific, medical, clinical discipline or related field, or related experience, Master's or PhD preferredMinimum of 6 years’ experience in Regulatory and Medical Writing or similar field requiredProven direct experience managing, mentoring, and developing Medical Writing professionalsAbility to anticipate and effectively resolve potential problems with client demandsDemonstrates managerial skill and experienceProficiency with MS Office applications. Hands-on experience with clinical trial and pharmaceutical development preferred. Good communication skills and willingness to work with others to clearly understand needs and solve problems. Excellent problem-solving and organizational skills. Familiarity with current ISO 9001 and ISO 27001 standards preferred. Familiarity with 21 CFR Part 11, FDA, and GCP requirements. Basic understanding of CROs and scientific & clinical data/terminology, & the drug development process