About this opportunity
MMS lists this Senior Manager, Regulatory and Medical Writing (Remote - US) opportunity in chicago, Illinois. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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 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 updates
Expert on styles of writing for various document types, including more complex document types; mentors others; document SME
Proficient with QC, MW tools, training, and processes; provides mentorship to others, SME
Utilizes and trains others on technologies such as AI-assisted authoring technologies where able
Proficient on resolving complex issues where analysis of situations or data requires an in-depth knowledge of organizational objectives
Implements strategic policies when selecting methods, techniques, and evaluation criteria for obtaining results
Provides 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 reports
Experienced in understanding impact of updates in related deliverables
Competent with managing client meetings and CRMs
Independently manages a project from start to finish
Proficient with identifying and mitigating project risk, including assessing client gaps
Adept 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 preferred
Minimum of 6 years’ experience in Regulatory and Medical Writing or similar field required
Proven direct experience managing, mentoring, and developing Medical Writing professionals
Ability to anticipate and effectively resolve potential problems with client demands
Demonstrates managerial skill and experience
Proficiency 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
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Worksite address
chicago, IL, 60290, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.