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Sr. Manager, Regulatory Services

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 Senior Regulatory Services Manager (Sr RSM) supports the Regulatory Services organization by managing a team of direct reports (8-10 employees) in matters of compliance, oversight and line management, coaching and mentoring, onboarding and development, ongoing billable activities, retention and employee engagement. Our people are our most valuable asset. The Sr RSM is a key contributor to developing our people and providing opportunities to learn, improve current skills and remain committed to our overall mission. The Sr RSM will still contribute subject matter expertise to the regulatory services provided to our clients but your main responsibility will be to support the staff in development of the final quality work.

 

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.

 

Proactively and effectively communicate to all stakeholders across the business to drive seamless professional development and optimal resource utilization

Provide administrative direction, provide solutions to obstacles of success, consistently encourage employees to learn new skills, guide professional development, recognize good and lagging performance, giving timely, specific and constructive feedback

Take steps to identify employee skills and work to strengthen those skills while developing new skills; have career discussions with employees to help them achieve the right skills to meet those objectives using a mix of silence, questioning and challenge

Strive to hire top talent and reduce undesirable turnover and learn to identify factors that help engage staff

Maintain strong understanding of corporate strategy, financial and structural processes and communicate appropriate information in a timely manner

Proactively alert senior management of issues requiring intervention, communication, or additional support

Conduct effective and regular 1:1 meetings and perform expedient follow-up (as applicable) and performance assessment

Communicate organizational changes, support employees through times of ambiguity or stressful workloads

Education, Experience, Training, and Knowledge:

BS/BA degree in relevant field, PhD, MD or PharmD preferred

3-5 years of regulatory writing experience as a lead author on multiple clinical documents such as Protocols, CSRs, ISS, ISE, and clinical sections of submission documentation.

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:

Understand how coaching differs from other helping behaviors, such as counseling and mentoring

Understands when own skills are not sufficient and refers an individual to a more experienced coach

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... 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: 845478

Posted On: Sep 17, 2021

Updated On: Oct 09, 2021