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Director, Global Submissions
vor 2 Wochen
Overview:
**About Certara**
Certara accelerates medicines using proprietary biosimulation software, technology and services to transform traditional drug discovery and development. Its clients include more than 2,000 biopharmaceutical companies, academic institutions and regulatory agencies across 62 countries.
Directors, at minimum, perform at the Principal Regulatory Writer Level with additional expectations and responsibility to contribute to leadership and strategy. As a Principal Writer, the Director of Global Submissions will:
- Work closely with client, internal and partner organization teams to lead development of strategies for organizing and preparing regulatory documents
- Lead project teams comprising internal and client team members as well as partner organizations.
- 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 considering 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 best-practices
- Provide coaching to writing staff and ensure all staff comply with company standard operating procedures (SOPs) and training requirements
**Responsibilities**:
- 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, clients, and external colleagues on regulatory submissions either in meetings or at conferences
- Brings in new clients and leads/participates in long-term strategic client relationships, enabling 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
- 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 skills development, and training
Qualifications:
**Education, Experience, Training, and Knowledge**:
- 15+ years of regulatory writing experience in clinical, nonclinical, CMC or pharmacovigilance reporting results
- PhD/PharmD/MS/MA or BS/BA with commensurate experience
- RAC certification is preferred
- 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 and publishing process, document and submission project management, clinical development and regulatory requirements from conceptual study design to final summary documents across the product lifecycle
- Strong understanding of the regulatory requirements for different phases of development and different regulatory pathways
- Knowledge of global health authority requirements
- Hands-on experience as the lead writer for a range of study-level and summary-level documents from start to finish
- Strong understanding of the clinical development process and detailed knowledge of clinical, nonclinical, or CMC document requirements for global submissions
**Skills & Abilities**:
- Intermediate proficiency with Microsoft Word skills (editing tools, creating and modifying tables, and inserting figures), macro-driven toolbars, and document management techniques
- Practice blameless problem solving, effectively managing all crisis communications and risks, and realizing business opportunities
- Ability to communicate difficult and complex submission-related 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 a negotiated 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 in and/or lead project interactions with clients and/or health authorities on a client’s behalf
- Clear
