Submission Senior Specialist - Cmc

3+ years

Not Disclosed

Hyderabad

10 June 26, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Description

Working with Us

Challenging. Meaningful. Life-changing. These aren’t words 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 breakthroughs in cell therapy, this is work that transforms patients' lives and the careers of those who do it. You’ll have the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving, diverse teams. 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.

About BMS Hyderabad

BMS Hyderabad is an integrated global hub focused on helping patients prevail over serious diseases by building sustainable and innovative solutions. This important science, technology, and innovation center supports a range of technology and drug development activities, helping us usher in the next wave of innovation.

Position Summary

Regulatory Information and Submission Management (RISM) is an organization that delivers Health Authority submissions and product data to support the BMS portfolio. It provides submission strategies for drug development, drug approval, and maintenance of market approvals. RISM sets the strategic business direction and related processes oversight for GRS systems.

The Senior Submission Specialist supports the planning, organization, and review of routine submissions for chemistry, manufacturing, and controls (CMC) and regulatory.

Key Responsibilities

Track, collect, and review all components for routine submissions to Health Authorities.
Interact with responsible parties to ensure quality submission documents for routine submissions.
Troubleshoot issues found in components received and interact with responsible parties for clarification or revision.
Assist with translation document management activities.
Perform other miscellaneous regulatory operational activities (e.g., US export waivers) as needed.
Build/manage dossier structures in the BMS Document Management System (DMS) for global CMC submissions.
Distribute, track, and archive non-eCTD submissions globally.
Serve as the lead contact to ensure Literature References are correctly in the DMS.
Draft eCTD content plans for CMC submissions.

Qualifications & Experience

BA/BS degree, preferably in a science or technology field.
3+ years of relevant submissions experience.

Key Competency Requirements

Foundational knowledge of global regulatory practices, electronic submission guidelines, and requirements.
Ability to communicate questions and issues as they arise with possible solutions.
Support other functions as appropriate.
Participate in submission team meetings.
Effective written and verbal communication skills.
Ability to work with supervision.
Ability to prioritize and maintain strong attention to detail.
Comfortable working in an environment that utilizes electronic document bases, databases, publishing, and computer systems (Microsoft Office, Outlook, eCTD viewers, and web-based applications) and be technically savvy with such systems.
Coordinate non-eCTD submissions with ISL Intercon Team.
Independently prepare cover letters, FDA forms, and submission content plans for routine maintenance investigational submissions.
Coordinate submission publishing with vendors/suppliers.
Update Verity with US planned submissions and update entries with submitted submissions.
Perform submission verification on published submissions to confirm eCTD compliance.

Compensation Grade

EG-090

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based, and remote-by-design jobs. The occupancy type assigned is determined by the nature and responsibilities of the role:

Site-essential roles require 100% of shifts onsite at your assigned facility.
Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive company culture.
Field-based and remote-by-design roles require the ability to physically travel to visit customers, patients, or business partners and attend meetings on behalf of BMS as directed.

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 before 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 adastaffingsupport@bms.com. Visit careers.bms.com/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.