- Demonstrate the ability to prioritize work and define steps needed to achieve project outcomes.
- Liaise closely with more senior colleagues to discuss issues and resolve conflicts.
- Provide suggestions for improving project efficiencies and results to the project technical lead.
- Seek out information from previous projects, other client work, or colleagues to complete assigned project activities.
- Produce quality work that meets the expectations of the project Team Lead and the client.
- Serve as a Regulatory Lead for small scale projects or work streams.
- Ensure accurate project reporting is in place as the main client contact.
- Ensure project team compliance and adherence to project scope and objectives.
- Identify new opportunities through Change In Scope or add-on businesses from existing work.
- Ensure timely project close-out activities are completed.
- Follow and implement the organization's consulting models and methodologies.
- Provide technical and/or business consulting services within your personal area of expertise.
- Previous experience working in industry in support of Global Labeling, Regulatory (Clinical/Safety), or Medical Writing for labeling updates.
- Understanding of the Regulatory processes required to update labeling of a product.
- Familiarity with the Company Core Datasheet (CCDS), and its implementation into labeling and artworks.
- Understanding of Safety Signal Management and the impact of confirmed safety signals on labeling.
- Understanding of Periodic Safety Update Reports (PSUR) and potential impact on labeling.
- Knowledge of the relationship between labeling and artwork processes.
- Familiarity with the Addendum to Clinical Overview (Module 2.5) and its preparation to support a labeling variation.
- Knowledge of Regulatory requirements for labeling updates in different regions (EU, US, and APAC).
- Understanding of EU readability and PIL (Patient Information Leaflet) testing.
- University degree in a scientific field
- Strong organizational and time management skills.
- Excellent communication and oral skills, with the ability to work efficiently as part of a team.
- Strong interpersonal skills.
- Proactive and efficient work ethic.
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Medical Operations Manager
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Market Access Leader, Emea
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Senior Manager Government Affairs
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Head of Patient Advocacy
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Medical Science Liaison
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Medical Project Manager
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Oxford Global Resources Madrid, España**Medical Project Manager**: · - Location: · Madrid, Spain · - Contact: · Susagna Sastre Magem · - Job type: · Contract · - Industry: · Pharmaceutical, Life Sciences, Biotechnology · Oxford Global Resources is hiring a Medical Project Manager who will be exclusively supporting a ...
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External Engagement Manager
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Novartis Madrid, España393852BR · **External Engagement Manager**: · Spain · **About the role** · **External Engagement Manager** · Location: Novartis, Madrid, Spain #LI-Hybrid · **About the Role**: · Provide a strategic view, professional advice, support and coordination in activities/relationships fo ...
Regulatory Affairs Professional - Alcobendas, España - Parexel
Descripción
When our values align, there's no limit to what we can achieve.
Parexel is seeking highly motivated and experienced individuals for the position a Senior Regulatory Affairs Associate. This role can be home, or office based in various locations in Europe. As part of our team, you will have the opportunity to work within a collaborative environment and deliver services within your technical expertise. Join us and make a difference in clinical research
Main Role Responsibilities:
Requirements:
Skills and Qualifications:
