2019- Associate Director/Director, Global Submissions

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Company: Certara
Category: Management Occupations
Published on 2021-07-25 19:04:15

Responsibilities:

 
  • 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
  • Associate Director/Director:

  • 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
  • Skills & Abilities: 

  • 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 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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