The Associate Director Regulatory Services Manager (AD, RSM) supports the Regulatory Services organization by managing a team of direct reports. Our people are our most valuable asset. The AD, RSM is a key contributor to developing our people by supporting the coaching and development efforts of the Sr RSMs and engaging in employee retention and engagement programs. An AD, RSM will also be accountable for providing support for resource management, strategy and business development, process improvement and technology enablement. The AD, RSM will still contribute subject matter expertise to the regulatory services provided to our clients but your main responsibility will be to support staff development and corporate positioning.
This role has dual responsibilities as a major contributor to leading and managing authorship for a variety of written deliverables across various therapeutic areas as well as supporting staff development and corporate positioning.
- Take overall accountability for the quality delivery of the work within Regulatory Services
- Proactively and effectively communicate with all employee stakeholders to drive seamless professional development and optimal resource utilization
- Maintain strong understanding of corporate strategy, financial and structural processes and communicate appropriate information in a timely manner
- Sponsor efforts that look at technology improvements to our business, both the core business and supporting service lines
- Provide leadership representation in customer interactions and work toward creating new channels of business from one project to the next
- Mentor managers- help them to work with their direct reports to identify and achieve goals that lead to advancement and career development within Synchrogenix
- Give frequent and candid performance feedback to build strengths and celebrate success and close any performance gaps
- Coach team members on ways to enhance their level of performance and develop their skills.
- Demonstrate trust in others by delegating responsibility
- Identify critical success factors in candidates to hire the right people
- Conduct effective and regular 1:1 meetings and performs expedient follow-up (as applicable) and performance assessment
Education, Experience, Training, and Knowledge:
- BS/BA degree in relevant field with 8-10 years of relevant experience required; PhD, MD or PharmD preferred
- Lead author on multiple clinical documents such as Protocols, CSRs, ISS, ISE, and clinical sections of submission documentation. Experience working on submission-level documents is required.
- Extensive knowledge of drug development and global regulatory requirements and submissions process
- Understand regulatory requirements for different phases of development and different regulatory pathways
- Knowledge of global health authority requirements
- Prior experience managing employees
Skills & Abilities:
- Proven leadership ability working with a team of high-level, high-intensity writers and editors at a variety of experience levels
- Ability to make independent decisions with the company and staff’s best interests in mind
- Ability to earn the respect of other company leaders
- Demonstrated ability to manage and oversee projects and/or resourcing for projects
- Ability to provide high-quality customer service and follow-through on all assignments
- Professional, personable demeanor
- Seeks out new ideas, is open to new ways of thinking from a wide range of sources, and works to implement those ideas;
- Comfortable with ambiguity; will confront unfamiliar situations with confidence and optimism
- Skilled at working with large, diverse teams
- Seeks opportunities to share information for the benefit of others
- Seeks the input of group members to encourage participation
- Sources and listens to all points of view and respects differing opinions when developing solutions