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1815 - Associate Director/Director, Global Submissions

Company: Certara Inc.
Location: New Haven
Posted on: June 12, 2021

Job Description:

Certara is hiring an Associate Director/Director, Global Submissions for our Synchrogenix division! The role can be based out of any US Certara office, or full time remote.

Certara is the global leader in advancing modern, efficient drug development.

We provide proven modeling & simulation, regulatory and real-world value assessment software platforms and services. In partnership with our clients, we help reduce clinical trial burden, accelerate regulatory approval and increase patient access to medicines.

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:

Associate Directors/Directors, lead Submission project teams to support our client's goals for medical development. AD/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 AD/Directors, 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 the client to make better business decisions
  • Owns all communications with the client, managing conflict with professionalism, including ambiguous situations and stressful circumstances to keep the project on time and within budget
  • Coaches others in submission tasks and strategies, providing support for internal process improvement across the organization
  • Serve as subject matter expert at conferences and professional meetings to promote the expertise of our organization
  • Use experience to support the creation of a technically expert organization with a strong depth of technical expertise, which include but are not limited to knowledge transfer, technical and soft skill development and training

Education and Experience Requirements

Associate Director:

  • 10+ years of regulatory writing experience with nonclinical, clinical, CMC or pharmacovigilance reporting
  • PhD/PharmS/MS/MA or BS/BA with commensurate experience

Director:

  • 15+ years of regulatory writing experience with nonclinical, clinical, CMC or pharmacovigilance reporting
  • PhD/PharmS/MS/MA or BS/BA with commensurate experience
  • RAC certification is preferred

Required Skills & Abilities:

  • Demonstrated ability to lead, develop, and manage all documents in a submission and to ensure consistency in messaging from the bottom up and from the top down
  • Strong understanding of the incorporation of key stakeholder input
  • Strong understanding of the document creation process, document and submission project management, clinical development and regulatory requirements from conceptual study design to final summary documents across the product lifecycle
  • Understands regulatory requirements for different phases of development and different regulatory pathways
  • Knowledge of global health authority requirements
  • Collective experience writing a range of study-level documents in their entirety and able to lead/own a study-level document
  • Strong understanding of the document creation process and of clinical development and study-level clinical operations from conceptual study design to final CSR/CTR
  • Intermediate proficiency with Microsoft Word skills (editing tools, creating and modifying tables and inserting figures) and document management techniques
  • Practice blameless problem solving, effectively managing all crisis communications, managing risks and realizing business opportunities
  • Ability to communicate difficult and complex ideas clearly and effectively to all stakeholders
  • Ability to own the overall submission taking responsibility for clarity of purpose, leading others toward the common goal within timeline and budget
  • Ability to collaborate with others to create and manage timelines for a submission, identifying dependencies, coordinating staff, vendors and clients toward successful completion of project
  • Participate and/or lead interaction with clients and/or health authorities
  • Clear and concise communicator, detail and process oriented
  • Strong interest in a submission leadership role that includes writing, team management, and collective accountability for product excellence

Certara bases all employment-related decision on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.

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Keywords: Certara Inc., New Haven , 1815 - Associate Director/Director, Global Submissions, Other , New Haven, Connecticut

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