Scientific Writer

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.

***Multiple levels and opportunities available***

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 Responsibilities

• 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.

Qualifications & Experience

• 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.

• Please note the position is not a remote working opportunity and is based in NJ.

To coordinate and author complex documents needed for regulatory submissions, ensuring the coordination and integration of the scientific, medical, and regulatory input from cross-functional team members.

Key Responsibilities

• Authors complex clinical documents [eg, Investigator's Brochures (IB), Protocols, Phase 2/3 Clinical Study Reports (CSR), briefing documents, Common Technical Document (CTD) summary documents, 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.
• Participate in document prototyping sessions, including document flow, logic, and consistency for assigned project prototypes, and maintain document prototypes and shells.
• 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.
• Serves as a liaison for external documentation support (when required), prepares specifications for the work, and ensures maintenance of good documentation principles as well as BMS documentation standards.
• Leads and influences a diverse group of authors of regulatory documents from a variety of disciplines without a reporting relationship.

Qualifications & Experience

• PharmD/PhD in a relevant scientific discipline or Master's/Bachelor's degree with approximately 5-10 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).
• Demonstrated ability to analyze and interpret complex data from a broad range of scientific disciplines.
• Good understanding of global pharmaceutical drug development and requirements for documentation authoring supporting 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.
• Please note the position is not a remote working opportunity and is based in NJ.

To coordinate and author documents needed for regulatory submissions, ensuring the coordination and integration of the scientific, medical, and regulatory input from cross-functional team members.

Key Responsibilities

• Coordinate and author regulatory documents [eg, Investigator’s Brochures (IB), development safety update reports, periodic benefit-risk evaluation reports, clinical study reports (CSR), protocols, and high-level summary documents] ensuring the coordination and integration of the scientific, medical, and regulatory input from development team members.
• 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.
• Maintain document prototypes and shells.
• 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 timely completion and high quality of assigned documents.
• Review and edit documents as required.

Qualifications & Experience

• PharmD/PhD in a relevant scientific discipline or Master's/Bachelor's degree with approximately 2-4 years of regulatory documentation. All PhD in biological sciences and PharmD candidates are considered.
• Demonstrated strong writing skills in authoring and managing the production of IB, Safety Aggregate Report, Clinical Protocols, and/or CSR.
• Ability to analyze and interpret complex data from a broad range of scientific disciplines.
• Understanding of global pharmaceutical drug development.
• 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.
• 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.