Regulatory/Sr. Regulatory Project Manager

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.
Synchrogenix, a Certara Company: Achieving Regulatory Success
As Certara's Regulatory Science division, Synchrogenix accelerates the regulatory submissions of medical innovations worldwide through customized regulatory solutions, including strategy, communications, operations and technology. Synchrogenix is comprised of some of the most respected talent in the industry, including thought leaders, writers and editors, and regulatory submissions specialists. Our people are talented, quality-minded, and client and stakeholder-oriented.
Synchrogenix's people are at the core of our success, and our most successful people are:
collaborative and value being part of a team
experts with a thirst for continued learning
consultative with an ability to articulate process and expertise
deadline-driven and able to operate in a fast-paced environment

Sr. Regulatory Project Manager
Job Overview:
The Senior Regulatory Project Manager collaborates cross-functionally within the Regulatory Services division to provide project management support to finite projects such as submissions to health authorities as well as to longer-term engagements at the portfolio level. This individual will be a member of the services delivery team taking responsibility for project management related tasks including but not limited to creating and managing timelines, tracking milestones, and facilitating communication within teams, with other functional divisions, and with clients to ensure alignment and efficiency while meeting the objectives of the project or the overall engagement in a timely manner.

Provides project management leadership for both simple and complex projects.
Oversees the entire portfolio of activities for an individual client coordinating across departments and business units. Serves as the main point of contact for a client in these engagements.
Anticipates the next step or phase of a project and proactively facilitates the successful execution of future activities.
Identifies barriers to successful engagements. Listens to stakeholders to understand their needs and goals relative to team goals. Successfully uses negotiation tactics to bring about issue resolution.
Identifies root cause drivers in various situations to promote efficiency and decision making.
Collaborates cross-functionally with other roles such as business development, finance, and contracting, escalating contractual requests or the need for changes to business development.
Leads a project team by eliminating hurdles to deadlines and raising awareness early when you identify risks. Contribute to risk minimization and mitigation activities.
Support internal organizational and continuous improvement initiatives.
Maintain current knowledge and understanding of relevant legal, regulatory, market, and technological developments, actively seeking out new learning opportunities for same.
Continually improve your understanding of typical project lifecycles encountered during therapeutics development and how individual projects fit within the landscape of therapeutic products development.
Provides supplemental financial oversight maintain awareness of budget burn rate and potential overages.
Schedules and manages internal and external team meetings, captures minutes, follows action items to completion.
Creates and maintains timelines for multi-component projects, implementing... 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: 897777

Posted On: Jan 15, 2022

Updated On: Feb 14, 2022