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

MMS; Austin (TX); On-site; USD 110,000 - 140,000; Full time

Job summary

MMS Holdings, a data-focused clinical research organization, seeks a Senior Medical Writer to lead regulatory writing and ensure compliant, publication-ready documents. You will mentor teammates, manage complex deliverables, and collaborate with clients across the drug development continuum.

With a global footprint and commitment to best practices, you will drive process improvements, apply AI-assisted tools, and oversee end-to-end project execution from initiation to submission, ensuring

Qualifications

• College graduate in scientific, medical, clinical discipline or related field; Master's or PhD preferred.
• Minimum of 6 years’ experience in Regulatory and Medical Writing or similar field.

Skills

Regulatory knowledge

Medical writing styles

QC & MW tools

AI-assisted authoring

Complex issue analysis

Strategic policy implementation

Team supervision/SME

Update impact awareness

Client meetings & CRMs

End-to-end project management

Risk mitigation

Client feedback handling

Education

Master's or PhD preferred

Bachelor's degree in science/medical field

Tools

MS Office

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