Associate Director, Scientific Writing
4 weeks ago
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.
Position Summary
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
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 displaysin 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 memberscoordination and efficient use of messages between internal development plans, IND and Marketing Authorization documentationtimely 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.-
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