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Regulatory Medical Writing Manager

Location: Livingston
Company: IQVIA
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"IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.
Why IQVIA
Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. In your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and, ultimately, improve outcomes for patients.
IQVIA offers a competitive salary and great benefits, including a profit-related annual bonus, paid leave, and private health insurance. Forge a career with greater purpose, make an impact, and never stop learning"
If you are looking to take your medical writing career to the next level as a manager in our team, we will provide you with opportunities to manage programs of studies, build and maintain relationships with key customers, and oversee the training and onboarding of teams. You will be able to develop your career in our team along either a management or technical route depending on your preference.
Job Overview
We are looking for a lead Medical Writer who is capable of leading on a wide variety of writing projects, using their best judgment and experience from working on programmes of studies. You will be the point of contact for issues and escalation and will be expected to design and deliver training sessions. Initially there will not be any direct line management of others.
Acting as Lead Medical Writer, on projects with multiple deliverables/components. Preparing assigned documents in accordance with IQVIA Standard Operating Procedures (SOPs) and customer requirements as well as to the agreed timelines. You will be comfortable performing senior review of all types of medical writing deliverables, providing feedback and guidance to junior staff, negotiates timelines and discusses/resolves customer comments. You will be responsible for keeping up to date with current writing/regulatory knowledge, including Good Clinical Practice (GCP), along with developments and advances in drug development writing.
Essential Functions
• Taking a leading role in preparing assigned documents, including, but not limited to, confirming the scope of the task, confirming templates and specifications, negotiating and adhering to timelines, organizing document reviews, communicating directly with the customer.
• Planning and organising workload for assigned projects and tasks: identify project needs, track timelines and implement customer requests.
• Using your initiative to tackle new/unusual document types and customer requirements.
• Chairing meetings. Able to act as point of contact for escalations and resolve conflict.
• Participating in bid defence meetings and discussions.
• Designing training materials and input into generic training plans for staff. Proposes topics for and prepares and delivers knowledge-sharing sessions for the global team.
• You may act as Project Manager for a small series of Medical Writing projects, that may involve elements of other functions.
• Complete project finance activities, including monitoring and forecasting budgeted hours.
• Independently propose, review and approve budgets and assumptions for a range of project types within remit.
• Likely to represent region or site on a Medical Writing initiative or cross-functional initiative.
• Drafting new Medical Writing Standard Operating Procedures (SOPs) for review and act as reviewer for Medical Writing SOPs, as assigned and appropriate.
Do you meet the skills, experience, and educational requirements of this role?
• Bachelor's Degree Bachelor's Degree in life sciences related discipline or related field
• Extensive experience in Regulatory Medical Writing, especially Protocols and CSR's (essential)
• In-depth knowledge of the structural and content requirements of clinical study reports, protocols, and similar documents and ability to identify deficiencies, errors, and inconsistencies in documents.
• Good understanding of common statistical methods used in clinical trials and/or interpretation of their results.
• Ability to effectively review a statistical analysis plan and to identify deficiencies, errors, and inconsistencies in statistical output
• Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner.
• Extensive experience in preparing CSRs and protocols independently to a consistently high standard, regardless of complexity or challenges.
• In depth knowledge of drug development, medical writing, and associated regulations. Good understanding of statistical principles and of medical terminology across a range of therapeutic areas.
• Excellent written and oral communication skills including grammatical/technical writing skills.
• Excellent attention to detail and accuracy.
• Confident and effective communication and negotiation skills with customers and project managers.
• Demonstrated ability to remain calm and assertive yet diplomatic in more challenging interactions with customers and colleagues.
• Experienced and effective in providing feedback and guidance to more junior staff.
• Ability to effectively manage multiple tasks and projects. Decisive amongst competing priorities.
• Confident in raising and discussing sensitive topics without management intervention.
• Ability to proactively evaluate risks and potential issues and seek solutions and discuss appropriately with colleagues and customers. Confidence in appropriately challenging the customer when document quality or timelines are at risk.
At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com .
At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com .
IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare - and human health - forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.
To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.
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