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

MMS; Jersey City (NJ); On-site; USD 120,000 - 170,000; Full time

Job summary

MMS is a data-focused clinical research organization seeking an experienced Medical Writing Lead to guide regulatory writing within trials and submissions. The role emphasizes mentorship, process improvement, and collaboration with cross-functional teams across a global CRO.

You will steward complex documents, ensure regulatory compliance, and drive quality across deliverables. Ideal candidates hold advanced scientific credentials, 6+ years in regulatory/medical writing, and strong leadership

Qualifications

• Regulatory writing expertise with familiarity in clinical documentation.
• Mentor and guide Medical Writing professionals.
• Proficient with QC and MW tools; understands regulatory updates.
• Experience with AI-assisted authoring technologies.
• Strong client-facing skills and CRM experience.
• Ability to manage projects end-to-end.

Responsibilities

• Lead regulatory writing projects from initiation to submission.
• Mentor junior writers and coordinate with SMEs.
• Manage client meetings and regulatory deliverables.

Skills

Regulatory writing

Clinical documentation

Regulatory updates

AI-assisted authoring

Client meetings & CRMs

Project leadership

Mentoring teams

Document SME

QC & MW tools

Risk management

Education

Master's or PhD preferred

Science/medical/clinical background

Tools

MS Office

MW tools

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 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

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