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

MMS Holdings Inc; Phoenix (AZ); Remote; USD 90,000 - 130,000; Full time

Job summary

MMS Holdings Inc is a leading data-focused clinical research organization seeking a Senior Medical Writer in Phoenix, AZ. You will contribute to regulatory submissions and medical writing across trial data, ensuring compliance with guidelines and high-quality deliverables.

You will mentor junior writers, manage projects from start to finish, and collaborate with cross-functional teams to meet deadlines and regulatory expectations.

Qualifications

• 6+ years of Regulatory and Medical Writing experience.
• Experience mentoring Medical Writing professionals.
• Familiarity with 21 CFR Part 11, FDA, and GCP.

Responsibilities

• Prepare and manage regulatory submission documents.
• Provide regulatory writing strategies and guidance.
• Lead small writing teams and oversee project timelines.
• Collaborate with clients and cross-functional teams.
• Address client feedback and ensure deliverables meet quality standards.

Skills

Regulatory writing

Medical writing

Project leadership

Mentoring

Client management

CRM proficiency

AI-assisted authoring

Education

Bachelor's degree in scientific/medical discipline

Master's or PhD preferred

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 (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, Master's 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.