Senior Director, Regulatory and Medical Writing

Summary

Join MMS, a leading CRO, as a motivated leader for our Regulatory and Medical Writing Team! You will oversee a team of writers, mentoring and coaching them to success. This role demands strong leadership, problem-solving, and client management skills. A minimum of 10 years' experience in Regulatory or Medical Writing and prior direct line management experience are required. You will be responsible for strategic input in resource management and functioning as a business lead, collaborating with various teams. The ideal candidate possesses a scientific or medical background and proficiency in MS Office applications. This is an opportunity to contribute to a company committed to delivering high-quality service and technology solutions.

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
• 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

Responsibilities

• Oversees a team of Regulatory and Medical Writers which includes being accountable for performance, team engagement, coaching and mentorship
• Considers impact intra- and extra- depart, and responds accordingly (training, initiatives, tools, templates, etc.)
• Proficient with QC, MW tools, training, and processes; provides mentorship to others, SME; 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 impact of updates in related deliverables; mentors others; advises on how initiatives and training in one area can impact other areas; mentorship across managers and departments
• Competent with managing client meetings and CRMs; provides mentorship to others; advises on how initiatives and training in one area can impact other areas; mentorship across managers
• Proficient with managing a project from start to finish; provides mentorship to others; considers impact to dept and business need; considerations across clients and dept; mentorship across managers
• Proficient with identifying and mitigating project risk, including assessing client gaps; provides mentorship to others; considers impact to dept and business need; considerations across clients and dept; mentorship across managers and departments
• Adept at handling client feedback with appropriate follow-up or resolution; provides mentorship to others; considers impact to department and business need; considerations across clients and department mentorship across managers
• Provides strategic input in Resource Management (project resourcing and utilization) as it related to potential areas of growth; training of existing colleagues, recruiting needs and changes to the organizational structure
• Functions as a Business Lead which includes being client facing, promoting the regulatory and medical writing service line, stays in close collaboration with the commercial team on proposals, the business development team on capabilities and bid defenses, with other Business Leads cross-functionally, and the marketing team for various initiatives

Preferred Qualifications

Hands-on experience with clinical trial and pharmaceutical development preferred