Associate Director, Scientific Writing

6 months ago


Uxbridge, United Kingdom Bristol Myers Squibb Full time

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.

  • Uxbridge, United Kingdom Bristol Myers Squibb Full time

    Working at Bristol Myers SquibbBristol Myers Squibb is a company that offers challenging and meaningful work opportunities. Our teams are diverse and rich in expertise, and we provide a platform for growth and development. As a Scientific Writing Manager, you will have the chance to work on complex regulatory documents and contribute to the development of...


  • Uxbridge, United Kingdom Bristol Myers Squibb Full time

    Transforming Lives through Regulatory DocumentationBristol Myers Squibb is a company that pushes the boundaries of what's possible in pharmaceutical drug development. As a key member of our team, you'll have the opportunity to make a meaningful impact on the lives of patients worldwide.Key ResponsibilitiesAuthor complex clinical documents for regulatory...


  • Uxbridge, United Kingdom Bristol Myers Squibb Full time

    About This RoleChallenging, meaningful, and life-changing work awaits at Bristol Myers Squibb. As a key member of our team, you'll have the opportunity to grow and thrive through uncommon opportunities and work alongside high-achieving teams rich in diversity.Key ResponsibilitiesAuthor complex clinical documents for regulatory submissions, ensuring good...


  • Uxbridge, United Kingdom Bristol Myers Squibb Full time

    Transforming Lives through Regulatory DocumentationBristol Myers Squibb is a company that pushes the boundaries of what's possible in pharmaceutical drug development. As a key member of our team, you'll have the opportunity to make a meaningful impact on the lives of patients worldwide.Key ResponsibilitiesAuthor complex clinical documents for regulatory...


  • Uxbridge, United Kingdom GILEAD Full time

    About the RoleWe are seeking a seasoned medical writer to join our dynamic team at Gilead as an Associate Director. As a key member of our Medical Writing group, you will play a crucial role in advancing our product strategies and ensuring successful licensure and maintenance of licensure for our medicinal products.


  • Uxbridge, United Kingdom Gilead Sciences Full time

    Gilead Sciences is a leading biopharmaceutical company with over 35 years of experience in developing innovative therapies to tackle some of the world's biggest health challenges.We are seeking an Associate Director Medical Writer to join our dynamic team. In this role, you will be responsible for authoring high-quality regulatory documents, including...


  • Uxbridge, United Kingdom Gilead Sciences, Inc. Full time

    Job OverviewWe are seeking an experienced Associate Director to lead our Medical Writing team at Gilead Sciences, Inc. The ideal candidate will have a strong background in medical writing and regulatory submissions, with excellent leadership and communication skills.Key ResponsibilitiesAuthor high-quality regulatory documents, including clinical study...


  • Uxbridge, United Kingdom Bristol-Myers Squibb Full time

    **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...


  • Uxbridge, United Kingdom Bristol-Myers Squibb Full time

    **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...


  • Uxbridge, United Kingdom Indiana Biosciences Research Institute Full time

    Observational Research ManagerAs a key member of our Data Strategy team, you will play a vital role in enabling the use of high-quality real-world data to meet priority evidence generation needs across our portfolio. Your expertise will aid our mission to serve patients around the world.You will partner with internal stakeholders and industry experts to...


  • Uxbridge, United Kingdom Bristol Myers Squibb Full time

    Transforming Lives through Regulatory ExcellenceBristol Myers Squibb offers a unique opportunity for Scientific Documentation Leads to join our team and contribute to the development of life-changing treatments.About Us:We are a pharmaceutical company dedicated to transforming patients' lives through innovative medicines and medical devices. Our mission is...


  • Uxbridge, United Kingdom Gilead Sciences, Inc. Full time

    About the Role:Gilead Sciences, Inc. is a leader in the development of innovative therapies that address some of the world's most pressing health challenges. We are seeking an experienced Associate Director to join our dynamic Medical Writing team.Key Responsibilities:Develop and author high-quality regulatory documents, including clinical study reports,...


  • Uxbridge, United Kingdom Amgen SA Full time

    Key Role in Amgen's SuccessAs a vital member of Amgen's Data Strategy team within the Center for Observational Research (CfOR), you will play a key role in enabling the use of high-quality real-world data to meet priority evidence generation needs across Amgen's portfolio.You will partner with internal stakeholders and industry experts to design, conduct,...


  • Uxbridge, United Kingdom Bristol Myers Squibb Full time

    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...


  • Uxbridge, United Kingdom Regeneron Pharmaceuticals, Inc Full time

    The Associate Director for Medical Strategy at Regeneron Pharmaceuticals, Inc. plays a crucial role in the development of medical strategy and planning of medical affairs activities. This position requires a deep understanding of Infectious Disease or a background in Internal Medicine, serving as a scientific and medical resource within the company. The...


  • Uxbridge, United Kingdom Bristol-Myers Squibb Full time

    Transform Patients' Lives through ScienceBristol Myers Squibb is a leader in the pharmaceutical industry, dedicated to transforming patients' lives through science. As an Associate Director of Scientific Writing, you will play a crucial role in ensuring the accuracy and quality of regulatory documents.About the RoleWe are seeking an experienced professional...


  • Uxbridge, United Kingdom Lovin- JobBoard Full time

    Medical Affairs Manager RoleAt Lovin- JobBoard, we are seeking a highly skilled Medical Affairs Manager to join our team. This role will be a key expert in immunology, establishing strategic partnerships with experts in clinical and scientific interest.The ideal candidate will possess sound medical affairs knowledge and the ability to thrive in a fast-paced,...


  • Uxbridge, United Kingdom Scientific Full time

    Senior Software Engineer - AI LabsScientific is seeking a highly skilled Senior Software Engineer to join our AI Labs team. As a key member of our team, you will be responsible for designing, developing, and deploying AI-driven solutions to improve workflows across the life sciences industry.Key Responsibilities:Collaborate with cross-functional teams to...


  • Uxbridge, United Kingdom Gilead Sciences International, Ltd. Full time

    Description   Job Title: Senior Associate, Medical Writing Business Operations Location: Cambridge or Stockley Park Gilead Sciences is a research-based biopharmaceutical company that discovers, develops, and commercializes innovative medicines in areas of unmet medical need including virology, oncology, and inflammation. With each new discovery...


  • Uxbridge, United Kingdom Proclinical Full time

    Proclinical are recruiting for a Regulatory Affairs Associate to join a pharmaceutical organisation. This role is on a contract basis and is either located in Uxbridge or Cambridge. **Key Skills and Requirements**: - Familiarity in an administrative field within a corporate or similar setting preferably within a healthcare sector. - Educated to a degree...