Senior Director, Protocol Writing Manager
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
To function as a strong people manager and technical leader with demonstrated management, scientific, and customer-focused leadership skills. Implements regulatory documentation standards that support speed and consistency of global interventional protocols across Phase 1 through 4 assets. The role will liaise within pharmaceutical/biotech industry to maintain knowledge of evolving/emerging industry standards and trends, and influence the industry environment regarding protocol writing.
Develop and communicate strategic direction for the group to ensure that the worldwide regulatory documentation supports BMS R&D goals and objectives.
Establish strategic partnership with other functions within BMS to maintain fully integrated and standardized processes and systems and a complete 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; facilitate the development of innovative solutions to resolve issues.
Ensure consistency in process, quality, and compliance standards for protocols developed by vendor partners.
Lead scientific writers in producing high quality documents based upon good documentation principles within established optimum timelines.
Seek talent from across the industry to help build a diverse, high performance group. Proactively and fluidly manage the group to take advantage of unplanned opportunities and overcome unforeseen obstacles, while achieving milestones.
Set clear performance standards, provide feedback and coaching, identify and fulfill training needs, and hold the group members accountable for key deliverables. Manage performance together with relevant cross-functional project team leaders.
Coordinate employee development to build individual capability and understanding of organizational breadth and depth. Enable the group to proactively identify and take advantage of career development opportunities.
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 for documents not covered adequately by in-house resources.
Influence other functions within BMS in matters pertaining to documentation processes and principles related to protocol development.
Develop training and resources on protocol development for writers and ensure adherence to documentation process standards and principles.
Communicate document standards and best practices to cross-functional teams. Educate stakeholders on impact of procedural changes. Interface with process owners to develop process improvement solutions.
Facilitate proactive sharing of knowledge and key learnings within the group and across other functions.
Interface across multiple functions to resolve issues, and champion an organizational culture to promote behaviors that lead to meaningful synergies and superior business performance.
Qualifications & Experience
PharmD/PhD/MD in a relevant scientific discipline or Master's/Bachelor's degree with a minimum of 10 years in pharmaceutical regulatory documentation. Prior regulatory documentation leadership in the development and approval of new drug applications/dossiers is preferred. All PhD in biological sciences and PharmD candidates are considered.
A proven record in managing a large group/project team with solid behaviors in cross-functional collaboration and communication.
Significant experience in writing protocols across all phases of development and across multiple therapeutic areas.
Knowledge of Good Clinical Practices and European Clinical Trial Regulation.
Demonstrated change management capabilities.
Experience in managing project teams and process workflows, and exhibits solid behaviors in cross-functional collaboration and communication.
Experience in working in a rapidly changing environment where decisiveness, adaptability, and communication are critical to success.
Experience in mentoring and professional development of junior colleagues in a group.
Good understanding of global pharmaceutical drug development and requirements for submission of regulatory dossiers to global health authorities.
Demonstrated ability to manage timelines and 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.
Please note the position is not a remote working opportunity and is based in NJ.
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.
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 with the resources to pursue their goals, both at work and in their personal lives.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
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