Senior Manager Regulatory and Medical Writing (Remote UK)

Are you looking to join a company where your contributions truly matter and where youll 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.

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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. Mentors managers (Associateand 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 disciplineor related field or related experience Masters or PhD preferred.
• Minimum of 6years 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.

Required Experience:

Senior Manager

Employment Type : Full-Time
Experience: years
Vacancy: 1