Drmarbys is hiring: Director, Regulatory and Medical Writing - Remote in Toledo

Director, Regulatory and Medical Writing - Remote

Join to apply for the Director, Regulatory and Medical Writing - Remote role at DRM Arby's.

About MMS: MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating. Our mission is to deliver high-quality service and technology solutions – rooted in strong science and decades of regulatory experience – that will assist our clients in developing and marketing life-changing therapies to positively improve lives worldwide. MMS recognizes that a talented staff is what drives our business forward.

Responsibilities:

1. Oversees a team of Regulatory and Medical Writers, accountable for performance, team engagement, coaching, and mentorship.
2. Considers impact intra- and extra-departmentally, and responds accordingly (training, initiatives, tools, templates, etc.).
3. Proficient with QC, MW tools, training, and processes; provides mentorship to others and connects different areas to create efficiencies.
4. Works on complex issues where analysis of situations or data requires an in-depth knowledge of the company.
5. Participates in corporate development of methods, techniques, and evaluation criteria for projects, programs, and people.
6. Directs and controls the activities of a broad functional area through several department managers within the company.
7. Oversees planning, staffing, and recommending and implementing changes to methods.
8. Experienced in understanding the impact of updates in related deliverables; mentors others.
9. Competent with managing client meetings and CRMs; provides mentorship to others.
10. Proficient with managing a project from start to finish; considers impact to department and business need.
11. Proficient with identifying and mitigating project risk, including assessing client gaps.
12. Adept at handling client feedback with appropriate follow-up or resolution.
13. Provides strategic input in Resource Management as it relates to potential areas of growth.
14. Functions as a Business Lead, including being client-facing and promoting the regulatory and medical writing service line.

Requirements:

1. College graduate in Scientific, Medical, or Clinical discipline or related field, or related experience; Masters or PhD preferred.
2. Minimum of 10 years’ experience in Regulatory or Medical Writing, or similar field required.
3. Prior direct line management experience required.
4. Ability to anticipate and effectively resolve potential problems with client demands.
5. Demonstrates managerial skill and experience.
6. Proficiency with MS Office applications.
7. Hands-on experience with clinical trial and pharmaceutical development preferred.
8. Good communication skills and willingness to work with others to clearly understand needs and solve problems.
9. Excellent problem-solving skills.
10. Good organizational and communication skills.
11. Understanding of CROs and scientific and clinical data/terminology, and the drug development process.

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