Senior Manager, Regulatory and Medical Writing - Remote Job at Drmarbys in Toled

Senior Manager, Regulatory and Medical Writing - Remote

Join to apply for the Senior Manager, 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.

We are looking for a motivated leader to join our Regulatory and Medical Writing Team!

Responsibilities:

1. Oversee a team of Regulatory and Medical Writers, accountable for performance, team engagement, coaching, and mentorship.
2. Consider impact intra- and extra-departmentally, and respond accordingly (training, initiatives, tools, templates, etc.).
3. Proficient with QC, MW tools, training, and processes; provide mentorship to others.
4. Work on complex issues requiring in-depth knowledge of the company.
5. Participate in corporate development of methods, techniques, and evaluation criteria for projects, programs, and people.
6. Direct and control the activities of a broad functional area through several department managers.
7. Oversee planning, staffing, and recommend changes to methods.
8. Manage client meetings and CRMs; provide mentorship to others.
9. Identify and mitigate project risk, including assessing client gaps.
10. Provide strategic input in Resource Management as it relates to potential areas of growth.
11. Function as a Business Lead, promoting the regulatory and medical writing service line.

Requirements:

1. College graduate in Scientific, Medical, or Clinical discipline or related field; 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 and organizational skills.
10. Understanding of CROs and scientific and clinical data/terminology, and the drug development process.

Seniority Level:

Director

Employment Type:

Full-time

Job Function:

Legal

Industries:

Smart Meter Manufacturing

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