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

MMS; Chicago (IL); On-site; USD 110,000 - 160,000; Full time

Job summary

MMS, a data-focused clinical research organization, invites a senior Medical Writer to guide regulatory documentation and regulatory submissions. You will mentor staff, lead complex documents, and ensure quality and compliance across clinical trial programs.

Join a Great Place to Work-certified team with a collaborative culture, driving innovative solutions for pharmaceutical, biotech, and medical device clients worldwide.

Qualifications

• Minimum 6 years’ experience in Regulatory and Medical Writing or similar field.
• Proven experience mentoring Medical Writing professionals.
• Strong understanding of ISO 9001 and ISO 27001 standards preferred.
• Familiarity with 21 CFR Part 11, FDA, and GCP requirements.
• Proficient with MS Office; experience with clinical trial data.

Responsibilities

• Oversee regulatory and medical writing projects from start to finish.
• Mentor and develop Medical Writing professionals; act as SME.
• Lead client meetings and manage CRMs; mitigate project risk.
• Implement strategic policies for document standards and timelines.
• Collaborate with cross-functional teams to meet deliverables.

Skills

Regulatory writing

Medical writing styles

QC tools

AI-assisted writing

Project leadership

Client meetings

Risk management

Issue resolution

Education

Bachelor/advanced degree in scientific field

Tools

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