Clinical Writer preparing regulatory and clinical documentation for innovative medical devices at Withings. Collaborating with technical teams and ensuring compliance with medical regulations.
About the role
- Consultant/Medical Writer generating compelling dossiers and value communications for ICON plc. Collaborating with multidisciplinary teams to shape the future of clinical development in the pharmaceutical industry.
Responsibilities
- Generates compelling dossiers and value communications - dossiers to include (global value dossiers (GVDs) and health technology assessment (HTA) submissions - (e.g. Payer Value proposition.
- Conducts technical project management, including scope of work development, contract initiation, and project milestones, timelines, deliverables, and budgets.
- Supports project lead/director on other projects as needed.
- Identifies risks with completing specific deliverables and effectively executes strategies to minimize them.
- Maintains understanding of project requirements and identifies scope creep as it happens.
- Communicates efficiently and effectively across the ICON project team.
- Communicates regularly with client’s assigned point of contact regarding project tasks, budgets and timelines.
- Establishes and maintains regular meetings with clients including drafting agendas, managing calendars, summarising notes and tracking agreed actions.
- Completes internal documentation and quality-checks the work of others.
- Participates in proposal and quote development.
- Develops compelling Payer Value Propositions (PVPs) tailored to payer priorities and evidence needs, enhancing product value communication strategies.
- Collaborates with cross-functional teams including health economists, clinical development leads, regulatory affairs and market access teams to ensure consistency and scientific accuracy across materials.
Requirements
- Excellent communication and interpersonal skills, with the ability to effectively collaborate with multidisciplinary teams and stakeholders.
- Experience Working in Market Access in the pharmaceutical industry (pharma company or consultancy).
- English professional level in speaking and writing.
- Direct and proven experience of writing HTA submissions.
- Direct and proven experience of writing GVDS.
- Direct and proven experience of generating PVP PowerPoint Decks /HE experience and understanding.
Benefits
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
Job title
Job type
Experience level
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Not specified
Degree requirement
Location requirements
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