Director Regulatory and Medical Writing
Director Regulatory and Medical Writing
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Salary Not Disclosed
1 Vacancy
Job Description
About MMS
MMS is an innovative datafocused 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 highquality service and technology solutions rooted in strong science and decades of regulatory experience that will assist our clients in developing and marketing lifechanging therapies to positively improve lives worldwide.
MMS recognizes that a talented staff is what drives our business forward. Identifying and attracting top talent and continual training to strengthen core skills are essential to its core mission. At MMS enthusiasm collaboration and teamwork are fostered knowing that a global and diverse talent pool makes the company stronger.For more information visitwww.mmsholdings.comor follow MMS onLinkedIn.
We are looking for a motivated leader to join our Regulatory and Medical Writing Team!
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 indepth 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 followup 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 crossfunctionally and the marketing team for various initiatives.
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.
- Handson 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 problemsolving skills.
- Good organizational and communication skills.
- Understanding of CROs and scientific andclinical data/ terminology andthe drug development process.
Required Experience:
Senior Manager
Employment Type
Full-Time
