Disclosure Specialist 2

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.

Disclosure Specialist 2

Job Title: Disclosure Specialist (2)

Contract: Permanent/Full-time

Department: DSSR – Global Medical Writing Division

Location: Livingston, Scotland - Potentially Home Based (UK)

IQVIA uses Human Data Science — the integration of data science, technology, and human science — to help customers address both current needs and future opportunities. But to get there, to make Human Data Science work, for you, you need a seamless integration of unparalleled data, advanced analytics, transformative technology, and deep domain expertise.

Job Overview
Act as a Subject Matter Expert (SME) for IQVIA colleagues and clients in the area of Clinical Trial Disclosure and take a leading role in providing consultancy and practical support to clients in meeting their Clinical Trial Disclosure-related obligations.

Essential Functions
• Act as Lead Disclosure Specialist for the preparation and/or coordination of assigned tasks to a high standard, including, but not limited to, clinical trial results postings, working in accordance with IQVIA SOPs and the applicable regulatory requirements.
• Participate in both internal and external project team meetings and liaise directly with the customer on disclosure issues and setting of timelines, as appropriate with limited supervision. Identify the needs of the project, negotiate and track project timelines, and implement client requests. Offer proactive solutions and advice to customers.
• Takes responsibility for managing workload for assigned tasks, in collaboration with senior staff.
• Maintain expertise in all elements of Clinical Trial Disclosure consultancy and support services, keeping abreast of developments in the Disclosure area to maintain our ability to provide consultancy to customers. A broad understanding of the requirements for protocol registration, maintenance, lay summaries, and document redaction is required.
• Liaise effectively with other functional groups with involvement in disclosure-related activities (e.g. Medical Writing, Regulatory & Start-Up, Global Patient & Site Solutions, Biostatistics, Privacy Analytics), to ensure a clear understanding of respective responsibilities and accountabilities.
• Review and monitor budget for assigned projects, including out of scope activities, and ensure that revenue is recognized as appropriate.
• Perform QC and/or senior review of documents or parts of documents prepared by other members of the Clinical Trial Disclosure group, including, but not limited to, clinical trial results postings. Give feedback and guidance to less experienced colleagues and contribute to their technical training and development.
• May deliver training to small groups or individuals within IQIVA on the role of the disclosure specialist and specific processes and/or client requests regarding Clinical Trial Disclosure.
• Complies with Company SOPs and participates in the implementation of new SOPs. May propose revisions to SOPs or suggest process improvements for consideration.

Qualifications

• Bachelor's Degree Life science-related discipline or related field
• Knowledge of all regulations relevant to Clinical Trial Disclosure, and to Medical Writing, including the structural and content requirements of CSRs. Note: requirements may evolve as the regulations evolve.

• At least 2.5 years' broad-ranging experience as a medical/technical writer, regulatory affairs professional, or closely related position within a pharmaceutical environment, including practical experience in disclosure-related activities

Join Us

Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of 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.

Forge a career with greater purpose, make an impact, and never stop learning.