Job Description

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. Strong industry experience, technology-enabled services, and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating, and the company has been recognized as a leading CRO in Global Health & Pharma\xe2\x80\x99s international awards programs for the last three consecutive years. For more information, visit or follow MMS on .

MMS is looking for a Director (or Senior Manager) for our growing Regulatory and Medical Writing Team where our corporate culture is unmatched!

Responsibilities

• 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. Reports directly to Operations Head.
• 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 dept mentorship across managers.

• College graduate in Scientific, Medical, or Clinical discipline or related field, or related experience, Masters or PhD preferred.
• Minimum of 10 years\xe2\x80\x99 experience in Regulatory or Medical Writing, or similar field required.
• 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.
• 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.

MMS Holdings