MMS
Senior Manager, Regulatory and Medical Writing (Remote - UK)
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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 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.
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Job Requirements
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- 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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