Director, Global Submissions

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

Job Overview:
Directors, lead Submission project teams to support our client's goals for medical development. Directors of Global Submissions enjoy the opportunity to author sections of the submission as well as assist clients with developing the regulatory strategy. You will lead project teams and work with Synchrogenix writers from around the world who are highly specialized in the CTD. Our Director, Global Submission work closely with client, internal and partner organization teams to lead development of strategies for organizing and preparing regulatory documents.
Responsibilities include, but are not limited to:
Lead project teams comprising internal and client team members as well as partner organizations.
Serve as liaison and subject matter expert internally and for clients, guiding and advising them on strategies and best practices for achieving approval from regulatory authorities for all document types that Synchrogenix publishes
Author and/or manage contributing writers and editors to develop documents per regulatory authority guidelines and requirements
Act as client advisor and proactive consultant to collaborate and anticipate the needs of the client based on your relationship and knowledge while pursuing new business opportunities
Manage overall budget for the project, liaise with finance and mentor others in fiscal responsibility and outcomes
Usher documents through the review process, conduct comment resolution meetings (CRMs)
Maintain collaborative, proactive, and effective communication with both client and internal teams
Lead project-related meetings and teleconferences and coach others in same
Provide coaching to writing staff and ensure all staff comply with company standard operating procedures (SOPs) and training requirements
Functions as a subject matter expert, guiding and advising clients on strategies for achieving approval from regulatory authorities (e.g., pooling strategies, data presentation, regulatory responses)
Leads multiple submissions concurrently (including more complex submissions): authoring, reviewing, overseeing budgets and timelines; developing submission plans/timelines including contingencies; prepares for agency meetings
Consults with and educates internal employees and external clients on regulatory submissions either in meetings or at conferences
Brings in new clients and leads/participates in long-term strategic client relationships for expanded or continued business opportunities
Communicates complex submission strategies clearly and effectively leading... 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: 1008853

Posted On: Jul 24, 2022

Updated On: Aug 19, 2022