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

MMS; Phoenix (AZ); On-site; USD 110,000 - 160,000; Full time

Job summary

MMS is an award-winning, data-focused clinical research organization (CRO). We are a Great Place to Work Certified organization, recognized for our culture and industry-leading employee retention.

We support 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

Qualifications

• 6+ years’ experience in Regulatory and Medical Writing or similar field.
• Proven experience mentoring and developing Medical Writing professionals.
• Ability to anticipate and resolve potential client demands.
• Demonstrates managerial skill and experience.
• Familiarity with ISO 9001, ISO 27001, FDA, and GCP.

Responsibilities

• Mentor medical writing staff and lead project teams from start to finish.
• Manage client meetings and CRM effectively.
• Incorporate regulatory updates into deliverables with accuracy.
• Identify and mitigate project risks; resolve client feedback promptly.

Skills

Regulatory knowledge

Medical writing

Project management

Client meetings

CRM

Mentorship

Leadership

MS Office

Problem solving

Communication

ISO 9001 familiarity

ISO 27001 familiarity

GCP familiarity

FDA Part 11

AI-assisted authoring

Clinical trial knowledge

Education

Bachelor's in scientific/clinical field

Master's or PhD preferred

Tools

MS Office

CRM software

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