Bristol-Myers Full Time Jobs From Home \u00a338 An Hour<\/p>\n

Industry: Private
\nEmployment Type: Full Time
\nWork Hours:\u00a08
\nSalary: \u00a335 – \u00a345Hour
\nLocation: United Kingdom
\nCompany:\u00a0Bristol-Myers Squibb<\/p>\n

Description:<\/p>\n

Bristol-Myers Full Time Jobs From Home \u00a338 An Hour<\/p>\n

Position Summary<\/p>\n

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.<\/p>\n

Key Words<\/p>\n

Scientific Writing, Medical Writer, Regulatory and Safety Documentation, Protocol Development, ICH CTD Documentation<\/p>\n

Bristol-Myers Full Time Jobs From Home \u00a338 An Hour<\/p>\n

Key Responsibilities<\/p>\n

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:
\ngood documentation principles (organization, clarity, scientific standards)
\nconsistency between text and tabular presentations or graphical displays
\nin compliance with BMS documentation standards and worldwide regulatory requirements
\nParticipate in relevant document subteam(s) and ensure effective planning and management of timelines for all components of assigned documents.
\nParticipate in document strategy sessions, including messaging, document flow, logic, and consistency for assigned projects.
\nPrepare 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).\u00a0
\nComply 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:
\noptimal communication between authoring team and development team members
\ncoordination and efficient use of messages between internal development plans, IND and Marketing Authorization documentation
\ntimely completion and high quality of assigned documents
\nReview and edit documents as required.
\nServe 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.
\nLead and influence a diverse group of authors of regulatory documents from a variety of disciplines without a reporting relationship.<\/p>\n

Bristol-Myers Full Time Jobs From Home \u00a338 An Hour<\/p>\n

Qualifications & Experience<\/p>\n

PharmD\/PhD\/MD in a relevant scientific discipline or Master’s\/Bachelor’s degree with approximately 5 years of pharmaceutical regulatory documentation. All PhD in biological sciences and PharmD candidates are considered.
\nDemonstrated 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).
\nAnalyze and interpret complex data from a broad range of scientific disciplines
\nThorough understanding of global pharmaceutical drug development and requirements for documentation authoring supporting major regulatory submissions.
\nDemonstrated ability to manage timelines and quality of work using strong organizational, communication, facilitation, and interpersonal skills in a cross-functional team.
\nWorking knowledge of a document management system and basic knowledge of the document publishing process.<\/p>\n

Bristol-Myers Full Time Jobs From Home \u00a338 An Hour<\/p>\n

About the Bristol-Myers\u00a0Squibb Company :<\/p>\n

Bristol-Myers Squibb (BMS) is a prominent global biopharmaceutical company with operations in the United Kingdom. Known for its innovative approach to pharmaceuticals, BMS focuses on the discovery, development, and delivery of transformative medicines for patients with serious diseases. Their research spans several therapeutic areas, including oncology, immunology, cardiovascular disease, and fibrosis.<\/p>\n

In the UK, Bristol-Myers Squibb operates through various facilities and partnerships. The company’s presence in the UK is significant, with a focus on research and development (R&D), clinical trials, and collaborations with local healthcare institutions and universities. The UK operations support BMS’s global mission to discover, develop, and deliver innovative medicines that help patients prevail over serious diseases.<\/p>\n

Bristol-Myers Squibb’s UK headquarters is located in Uxbridge, West London. This site serves as a hub for their commercial and administrative functions. Additionally, the UK team plays a crucial role in conducting clinical trials, which are essential for the development of new therapies. These trials often involve collaborations with the National Health Service (NHS) and various academic institutions, ensuring that the UK remains at the forefront of medical research and innovation.<\/p>\n

The company is committed to contributing to the local community and healthcare landscape in the UK. This includes initiatives aimed at improving patient outcomes, enhancing access to medicines, and supporting health-related education and awareness programs. BMS UK also engages in various corporate social responsibility activities, emphasizing sustainability and ethical business practices.<\/p>\n

Overall, Bristol-Myers Squibb in the United Kingdom exemplifies the company’s global commitment to innovation, collaboration, and patient-centric care, striving to make a meaningful impact on health and well-being.<\/p>\n

Bristol-Myers Full Time Jobs From Home \u00a338 An Hour<\/p>\n

Bristol-Myers Full Time Jobs From Home \u00a338 An Hour – SarkariVaccancy<\/p>\n

Apply Now For This Job<\/a><\/h2>\n","protected":false},"excerpt":{"rendered":"

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