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Associate Director, Regulatory Services Management

at Certara USA, LLC in Wilmington, Delaware, United States

Job Description

At Certara, we accelerate medicines to patients by partnering with life science innovators.

In the past 6 years, over 90% of companies that received new drug approvals by the FDA used our software or services. Our integrated and proprietary end-to-end platform with biosimulation, regulatory science, and market access solutions combined with our strong team of scientists and subject matter experts enable our clients to have:

informed decision-making & reduced clinical trial burden

higher R&D productivity

improved patient outcomes & increased patient access to medicines

accelerated regulatory approval

Certara is a global team that fosters and nurtures a diverse and inclusive culture. We are proud to be an Equal Opportunity Employer. The collective sum of our individual differences, life experiences, knowledge, innovation, self-expression, and unique capabilities and talent represents a significant part of our culture, our reputation and our achievement.

Together with our partners, we use biosimulation and technology-enabled services to transform drug discovery and development across all therapeutic areas and innovative therapies.

 

Job Overview:

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.

 

Responsibilities:

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... For full info follow application link.

 

Certara is an Equal Opportunity Employer. Certara does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.        

 

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Job Posting: 845475

Posted On: Sep 17, 2021

Updated On: Oct 09, 2021