EG-140 - Regulatory Affairs / Medical Writing

Bristol Myers Squibb • Princeton, NJ

13d • $170,880 - $207,061 • Hybrid

About The Position

To coordinate and author complex regulatory documents needed for regulatory submissions ensuring the coordination and integration of the scientific, medical, and regulatory input from development team members for assets in the immunology and cardiovascular therapeutic areas. Implements regulatory documentation standards that support speed and consistency of regulatory submissions across all full development / life cycle management assets and geographies.

Requirements

• PharmD/PhD/MD in a relevant scientific discipline or Master's/Bachelor's degree with approximately 10 years of pharmaceutical regulatory documentation. All PhD in biological sciences and PharmD candidates are considered.
• Demonstrated expert writing skills in authoring and managing the production of clinical and regulatory document including registrational submission documents (eg, briefing documents, CTD summary documents, responses, pediatric plans).
• Analyze and interpret complex data from a broad range of scientific disciplines.
• Thorough understanding of global pharmaceutical drug development and requirements for documentation authoring supporting major regulatory submissions.
• Demonstrated ability to manage timelines and quality of work using strong organizational, communication, facilitation, and interpersonal skills in a cross-functional team.
• Working knowledge of a document management system and basic knowledge of the document publishing process.
• Experience in the areas of state-of-the-art documentation processes and technology.

Responsibilities

• Author complex clinical documents needed for regulatory submissions (eg, Pivotal Phase 3 CSRs, CTD summary documents, Pediatric Investigational Plans, Investigator’s Brochures, HA Briefing Books, responses to Health Authority queries) for timely submission to health authorities worldwide according to: good documentation principles (organization, clarity, scientific standards), consistency between text and tabular presentations or graphical displays, in compliance with BMS documentation standards and regulatory requirements.
• Participate in relevant document subteam(s) and ensure effective planning and management of timelines for all components of assigned documents.
• Participate in document strategy sessions, including messaging, document flow, logic, and consistency for assigned projects.
• Prepare document prototypes, including the document flow, logic, and consistency for assigned project prototypes, and maintain document prototypes and shells.
• Lead or co-lead (with Documentation Lead) teams to define content and organization for complex documents (eg CTD summary documents).
• Comply with internal processes and guidelines while managing the review process and, on an ongoing basis, resolve issues, errors, or inconsistencies with pertinent team members to ensure: optimal communication between authoring team and development team members, coordination and efficient use of messages between internal development plans, IND and Marketing Authorization documentation, timely completion and high quality of assigned documents.
• Review regulatory and clinical 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.
• Facilitate proactive sharing of knowledge and key learnings within the group and across other functions.
• Lead and influence a diverse group of authors of regulatory documents from a variety of disciplines without a reporting relationship.

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Work-life benefits include: Paid Time Off
• US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
• Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
• Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
• All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior