Bristol-Myers Squibb Company

Associate Director, Scientific Writing

Location
Princeton, NJ
Posted
Aug 09, 2019
Ref
R1517017
Required Education
Doctorate/PHD/MD
Position Type
Part time
Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Position Objective:
To author complex regulatory documents ensuring the coordination and integration of the scientific, medical and regulatory input from development team members. Contribute to the planning and execution of the regulatory document strategy that supports Early Development teams (EDT) development plans. To support the performance goals (including quality and timeliness) for filing worldwide regulatory dossiers as planned by the EDT.

Expected Areas of Competence:
Strategy:
1. Participates in the development of worldwide regulatory documentation strategy in support of the development team's target labeling objectives, timely approvals, and other regulatory commitments
2. In partnership with the Documentation Lead, implements regulatory documentation strategy and standards that support speed and consistency of regulatory submissions across all assets and geographies
3. Champions the GSRD organization across multiple functions and identifies meaningful synergies
4. Identifies opportunities to participate / influence regulatory policy and climate with respect to documentation and dossier presentation in support of project goals and BMS preferences
5. Applies knowledge of internal and external guidances in providing feedback to the EDTs on issues related to regulatory documentation

Execution:
1. Drives 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
2. Reviews project-specific story boards, prototypes, and model documents, as needed
3. 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
4. In collaboration with the Documentation Lead, 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
5. 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

People:
1. Collaborates with members of the expanded Global Scientific and Regulatory Documentation (GSRD) organization
2. Influences a diverse group of authors of regulatory documents from a variety of disciplines without a reporting relationship in matters pertaining to documentation processes and principles
3. Proactively shares knowledge and key learnings within and across development teams

Knowledge Desired:

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:

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, etc), 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 global health authorities (e.g., 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

Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.