Position Summary
Leads the establishment and ongoing development of a Therapeutic Area (TA) team of scientific writers. Demonstrates in-depth expertise in the relevant TA and specific assets, enabling effective leadership in the creation of content libraries when warranted. Applies advanced regulatory documentation skills to guide and/or support the implementation of new processes, tools, and continuous improvements within the scope of departmental responsibilities. Demonstrates strong managerial, scientific, and customer-focused leadership skills. Applies regulatory documentation standards that enhance efficiency and ensure consistency across the entire development and life cycle management of TA assets, across geographic regions. Leads strategic planning for document automation and leads innovative initiatives to support those goals.
_**The person in this role will be required to report to the Lawrenceville, New Jersey location.**_
Duties/Responsibilities
- Work with Head of GSRD and direct reports to develop and lead the TA writing teams in support of global regulatory documentation for the BMS R&D goals and objectives.
- Establish strategic partnerships with other functions within BMS to maintain fully integrated and standardized processes and systems and ensure alignment of roles and responsibilities to meet BMS R&D objectives and priorities.
- Establish and maintain documentation standards, templates, and best work practices that are consistent with internal and external guidelines for regulatory documentation and submissions; facilitate the development of innovative solutions to resolve issues.
- Lead scientific writers in producing high-quality strategically written documents based on good documentation practices within established optimum timelines.
- Seek exceptional talent from across the industry and within BMS.
- Assess resource requirements for all projects, assign resources according to BMS R&D priorities, and prepare criteria and strategies for the selection and maintenance of external documentation support (if applicable) for documents not covered adequately by in-house resources.
- Review regulatory, clinical, and safety documentation according to good documentation practices (organization, clarity, scientific standards), to establish consistency of content within TA and asset, and compliance with BMS documentation standards and worldwide regulatory requirements.
- Support skillset development for scientific writers as needed for BMS pipeline, technological advancements, regulatory developments, and other opportunities. Enable the group to proactively identify and take advantage of career development opportunities.
- Ensure regular entry of data to support departmental metrics and analytics.
- Influence other functions within BMS in matters pertaining to regulatory documentation processes and principles.
- Serve as process owner, lead, or subject matter expert as needed. Lead the development of training on regulatory documents from a variety of disciplines and provide to writers regardless of reporting relationship in matters pertaining to documentation processes and principles. Lead the development of resources for writing team to ensure quality standards.
- Facilitate proactive sharing of knowledge and key learnings within the group and across other functions.
- Interface across multiple functions to mediate conflict resolution, and champion an organizational culture to promote behaviors that lead to meaningful synergies and superior business performance.
- Represents BMS at industry and professional meetings to maintain knowledge of evolving industry standards and trends.
Reports to the Executive Director, Global Scientific and Regulatory Documentation
Qualifications
- A proven record in managing group/project team with exemplary behaviors in cross-functional collaboration and communication.
- Extensive experience in writing and overseeing high-quality regulatory documentation, including high-level summary documents (preferably clinical).
- Significant experience in managing project teams and process workflows and exhibits solid behaviors in cross-functional collaboration and communication.
- Significant experience in working in a rapidly changing environment where decisiveness, adaptability, and communication are critical to success.
- Significant experience in mentoring and professional development of colleagues in a group.
- Advanced understanding of global pharmaceutical drug development and requirements for submission of regulatory dossiers to global health authorities.
- Demonstrated ability to manage timelines and ensure quality of work using strong organizational, communication, facilitation and interpersonal skills in a cross-functional team.
- Experience in the areas of state-of-the-art documentation processes and technology.
Educational/Experience/Licenses/Certifications:
Masters/PharmD/PhD/MD in a relevant scientific discipline with a minimum of 15 years in pharmaceutical regulatory documentation. Prior regulatory documentation leadership in the development and approval of new drug applications/dossiers is preferred.
_If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career._
