Bristol Myers Squibb Associate Director, GSRD (Team Leader) in Hyderabad, India
Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
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. Read more: careers.bms.com/working-with-us .
BMS Hyderabad is an integrated global hub where our work is focused on helping patients prevail over serious diseases by building sustainable and innovative solutions. This important science, technology, and innovation center will support a range of technology and drug development activities that will help us usher in the next wave of innovation.
BMS Hyderabad is an integrated global hub where our work is focused on helping patients prevail over serious diseases by building sustainable and innovative solutions. This important science, technology, and innovation center will support a range of technology and drug development activities that will help us usher in the next wave of innovation. #HYDDD
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 regulatory submissions across all full development / life cycle management assets and geographies.
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.
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, provides feedback and coaching, identifies and fulfills training needs, and holds the group members accountable for key deliverables. Manages 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.
Review regulatory, clinical, and safety documentation according to:
good documentation principles (organization, clarity, scientific standards)
consistency between text and tabular presentations or graphical displays
compliance with BMS documentation standards and worldwide regulatory requirements
Influence other functions within BMS in matters pertaining to regulatory documentation processes and principles.
Develop 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. Develop 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.
Key Competency Requirements
· Experience in leading a project team with solid behaviors in cross-functional collaboration and communication.
· Significant experience in writing high-quality regulatory documentation, including high-level summary documents (preferably clinical).
· 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.
PhD/MD/PharmD or MS/BS with prior experience
PharmD/PhD/MD in a relevant scientific discipline or Master's/Bachelor's degree with approximately 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.
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.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to email@example.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Company: Bristol Myers Squibb
Req Number: R1569042
Updated: 2023-06-04 02:41:05.695 UTC
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.