Associate Director, EDT Documentation Lead, Early Development

We are an EasyHiring recruiting company that is looking for candidates for our partners for the position of Associate Director, EDT Documentation Lead, Early Development in Frenchtown, NJ for work in Frenchtown, NJ

Position Objective:

Provide strategic direction to effectively drive the development and implementation of the regulatory documentation strategy to deliver key R&D business objectives, support “speed to patient”, and facilitate submissions of investigational applications for early development of new molecular entities (NMEs) in the intended key markets. Provide leadership in planning and supporting the regulatory submission(s) by Early Development teams (EDT), and align with Early Development Committee (EDC) on prioritization and execution of overall global development strategy.

Expected Areas of Competence:

Submission Strategy:

1. Develops and communicates strategic direction for worldwide regulatory documentation in support of investigational applications in alignment with BMS R&D goals and objectives.

2. Implements regulatory documentation standards that support speed and consistency of regulatory submissions across all assets and geographies.

3. Drives regulatory documentation strategy and processes to ensure timely submission of investigational applications for early development of NMEs in the intended key markets in accordance with BMS R&D objectives and commercial priority.

4. Facilitate transition between early and full development with emphasis on speed-to-patient and high-velocity projects

5. Champions the GSRD organization across multiple functions and identifies meaningful synergies.

6. Identifies opportunities to participate / influence regulatory policy and climate with respect to documentation and dossier presentation in support of project goals and BMS preferences.

7. Applies knowledge of internal and external guidances in providing feedback to the EDTs on issues related to regulatory documentation.

Execution:

1. Proactively addresses business need, prioritization of regulatory submissions, and allocates resources to meet strategic BMS R&D early development goals.

2. Contributes to the development of effective documentation processes and standards; ensures (i) implementation of the processes that support EDT goals and (ii) maintenance of BMS R&D good documentation principles and standards.

3. Implements major BMS R&D-wide change management initiative to improve cycle time and quality of regulatory documentation for global investigational applications.

4. Reviews project-specific story boards, prototypes, and model documents, as needed.

5. Advises and authors complex clinical documents (e.g. IBs, Phase 1/2 clinical study reports, high-level summary documents, background documents) for timely submission to health authorities worldwide

6. Proactively reviews progress against the investigational application/dossier plans, leads group members in identifying opportunities and threats in terms of documentation activities, and drives potential solutions with key team members.

7. In conjunction with appropriate disciplines, identifies and ensures management of external documentation when required for in-licensed asset packages.

8. Comply with internal and external processes and guidelines while managing the review process and, on an ongoing basis, resolve issues, errors, or inconsistencies with pertinent team members to ensure timely completion and high quality of assigned documents

Knowledge Desired:

(3-5 pre-hire areas of knowledge)

1. PhD/MD/PharmD in a relevant scientific discipline, or MS/BS with thorough understanding of scientific principles and hypothesis testing and at least 5 years of pharmaceutical regulatory documentation.

2. Analyzed and interpreted complex data from a broad range of scientific disciplines, including pharmacokinetics, pharmacodynamics, ECG, immunogenicity, bioanalytical and pediatric reporting requirements.

3. Thorough understanding of global pharmaceutical drug development, both non clinical and clinical, and requirements for submission of regulatory dossiers for investigational applications to global health authorities.

4. Broad knowledge of the pharmaceutical industry and major worldwide regulatory agencies, including their process and organization.

5. Thorough understanding of the US and EU regulatory requirements; good understanding of Japanese and other major international regulatory requirements and procedures with an emphasis on early development deliverables to facilitate global readiness of full development program.

Experiences Desired:

(5-7 pre-hire ideal experiences)

1. Prior early development clinical trial experience preferred, with an emphasis on PK, PD, ECG, immunogenicity, bioanalytical, and pediatric reporting requirements.

2. At least three major submissions (IND/CTx/NDA/MAA/J-NDA), preferably in different therapeutic areas and a strong depth and breadth of knowledge of the submission process and significant experience in writing high-level summary documents for global registrations.

3. Exhibits solid behaviors in cross-functional collaboration and communication.

4. Experience working with FDA/EMEA/PMDA/TGA/SFDA on a wide range of issues including responding to questions, project-related meetings, and Advisory Committee meetings

5. Experience in the areas of state-of-the-art documentation processes and technology.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Job Type: Full-time

Work Location: On the road