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

MMS Holdings Inc; Austin (TX); À distance; USD 110 000 - 170 000; Plein temps

Résumé du poste

MMS Holdings Inc. is seeking an experienced Regulatory and Medical Writer to join our clinical research leadership team in Austin, TX.

You will mentor staff, manage complex writing projects, and ensure compliance with regulatory standards across FDA, GCP, and ISO guidelines. Ideal candidates bring a strong background in regulatory strategy, document planning, and communications with sponsors, along with hands-on experience using MW tools and AI-assisted authoring as appropriate.

Qualifications

• Requires degree in life sciences or related field with strong regulatory/medical writing background.
• Minimum of 6 years’ experience in Regulatory and Medical Writing or related field.
• Proven experience managing, mentoring, and developing Medical Writing professionals.
• Familiar with ISO 9001 and ISO 27001 standards.

Responsabilités

• (Not explicitly stated in HTML; no responsibilities listed)

Connaissances

Regulatory writing

Medical writing

Mentoring

Project management

Client meetings

ISO 9001 knowledge

ISO 27001 knowledge

FDA 21 CFR Part 11

GCP knowledge

MS Office proficiency

Formation

Bachelor's degree or higher in life sciences

Outils

MS Office

MS Word

MS Excel

Description du poste

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.