Associate Director, Scientific Writing

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. Implements regulatory documentation standards that support speed and consistency of regulatory submissions across all full development / life cycle management assets and geographies.

Key Words

Scientific Writing, Medical Writer, Regulatory and Safety Documentation, Protocol Development, ICH CTD Documentation,

• Author complex clinical documents needed for regulatory submissions (eg, Protocols, Pivotal Phase 3 CSRs, CTD summary documents, Risk Management Plans, Pediatric Investigational Plans, Advisory Committee Brochures, 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 worldwide 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 and external 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 and edit documents as required.


• Serve as a liaison for external documentation support (when required), prepare specifications for the work, and ensure maintenance of good documentation principles as well as BMS documentation standards.


• Lead and influence a diverse group of authors of regulatory documents from a variety of disciplines without a reporting relationship., 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 that you are assigned is determined by the nature and responsibilities of your 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. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

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 adastaffingsupport@bms.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.


• 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 strong 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.
  
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