Drmarbys is hiring: Director, Regulatory and Medical Writing - Re...
Drmarbys - Toledo, OH, United States, 43614
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Director, Regulatory and Medical Writing - Remote
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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:
- Oversees a team of Regulatory and Medical Writers, accountable for performance, team engagement, coaching, and mentorship.
- Considers impact intra- and extra-departmentally, and responds accordingly (training, initiatives, tools, templates, etc.).
- Proficient with QC, MW tools, training, and processes; provides mentorship to others and connects different areas to create efficiencies.
- Works on complex issues where analysis of situations or data requires an in-depth knowledge of the company.
- Participates in corporate development of methods, techniques, and evaluation criteria for projects, programs, and people.
- Directs and controls the activities of a broad functional area through several department managers within the company.
- Oversees planning, staffing, and recommending and implementing changes to methods.
- Experienced in understanding the impact of updates in related deliverables; mentors others.
- Competent with managing client meetings and CRMs; provides mentorship to others.
- Proficient with managing a project from start to finish; considers impact to department and business need.
- Proficient with identifying and mitigating project risk, including assessing client gaps.
- Adept at handling client feedback with appropriate follow-up or resolution.
- Provides strategic input in Resource Management as it relates to potential areas of growth.
- Functions as a Business Lead, including being client-facing and promoting the regulatory and medical writing service line.
Requirements:
- College graduate in Scientific, Medical, or Clinical discipline or related field, or related experience; Masters or PhD preferred.
- Minimum of 10 years’ experience in Regulatory or Medical Writing, or similar field required.
- Prior direct line management experience required.
- 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 skills.
- Good organizational and communication skills.
- Understanding of CROs and scientific and clinical data/terminology, and the drug development process.