Medical Operations and Publication Specialist
hace 1 mes
Overview
JOB FUNCTION:
This role is primarily dedicated to delivering technical assistance in the execution and management of local studies aimed at generating data in epidemiology and Real World Evidence (RWE) research. The position requires maintaining up-to-date knowledge of relevant legislation and local regulations to ensure high-quality implementation of these studies, supporting the Therapeutic Area Head in collaboration with the Clinical Operations Coordinator.
Under the guidance of the Head of Evidence and Value Generation, and in close partnership with Local Medical Area Teams, the individual will also facilitate medical publications and communication initiatives.
KEY RESPONSIBILITIES:
Evidence Generation:
- Provide operational support and oversight for local epidemiological and RWE clinical studies, including Company Sponsored Studies, Collaborative Clinical Research, and Investigator Initiated Research, in conjunction with the Local Clinical Operations Coordinator and Therapeutic Area Medical team. This includes: Initiating start-up activities, managing administrative tasks for obtaining necessary internal and external approvals, overseeing contracts, and supervising CROs.
- Ensure compliance with Takeda procedures and local regulations to uphold the quality of investigational projects.
- Collaborate with the Therapeutic Area Medical team to identify suitable study sites.
- Maintain and update local and international study databases.
Medical Publications:
- Work closely with local medical affairs, medical publication agencies, and external authors to execute the global publication strategy.
- Identify, select, and manage third-party providers and independent contractors to ensure timely and high-quality publication outputs, adhering to Takeda Standards, SOPs, and good publication practices.
- Oversee specific publication project budgets and contracts.
- Facilitate and support the internal and external review and approval processes for publications in accordance with Takeda's Global Publication Standards and applicable guidelines.
- Monitor local publication metrics and provide necessary reports to the Head of Evidence and Value Generation.
Takeda Principles and Standards:
- Adhere to compliance, ethical codes, and legal standards.
- Ensure that the principles of Patient-Trust-Reputation-Business (PTRB) guide planning and decision-making processes. Promote and embody the Takeda-ism philosophy and values, acting as a role model to foster a culture of integrity and open communication.
- Report any adverse reactions to the pharmacovigilance department immediately upon awareness, following internal procedures.
EDUCATION, EXPERIENCE, SKILLS, AND KNOWLEDGE
Education:
- A university degree in Medical Health or Biological Sciences.
Experience:
- Prior or current enrollment in a Postgraduate Pharmaceutical industry course.
- Previous experience in the pharmaceutical industry, particularly in Clinical Operations, is advantageous.
- A scientific background that enables a solid understanding of clinical trial data and study design.
- Familiarity with clinical trial reports, data presentation, and interpretation.
- Knowledge of regulatory and legal guidelines pertaining to publication planning and execution.
Skills:
- A strong desire for knowledge (technical, clinical, medical, scientific) with the ability to quickly assimilate information and present clinical data clearly and concisely.
- Proficiency in IT skills, including Microsoft Word, Excel, and PowerPoint.
Knowledge:
- Comprehensive understanding of applicable GXP regulations, Good Clinical Practices, ICH Guidelines, and National Code of Practice.
- Familiarity with the overall audit process, including design, conduct, and reporting.
- A strong desire for technical, clinical, medical, and scientific knowledge (Desirable).
Takeda Core Capabilities:
Takeda Leadership Behaviors:
- Clear demonstration of leadership behaviors, which are crucial for success within the organization: Strategic Thinking, Inspiring Others, Delivering Priorities, and Elevating Capabilities.
Digital Knowledge:
- Continuous improvement in everyday digital tools and platforms relevant to the position, including artificial intelligence (e.g., CRM, Portals, PowerBI) to enhance efficiency and effectiveness.
Data-Driven Decision Making:
- Competence in utilizing facts, metrics, and data to inform business decisions relevant to the role and leverage insights for strategic planning.
- Clarity on data sources, management, and analysis pertinent to the role.
Agility and Adaptability:
- Ability to swiftly adapt to change and embrace new business models, priorities, and a digital mindset.
- A results-oriented approach, capable of developing plans and solutions to achieve expected outcomes even in uncertain circumstances.
- Enhance efficiency and scalability by reusing successful elements of existing solutions within the organization.
Collaborative Mindset:
- Embrace a collaborative approach to problem-solving and innovation.
Continuous Learning:
- Adopt a lifelong learning mindset and take ownership of personal development, proactively planning for growth.
- Commitment to staying informed about the latest market trends, digital technologies, and best practices in the pharmaceutical industry.
PHYSICAL DEMANDS:
- Manual dexterity required for operating office equipment (e.g., computers, phones).
- Ability to travel for meetings, audits, and training sessions.
TRAVEL REQUIREMENTS:
- Willingness to travel and be away from home for extensive geographic territories and central briefings, including international destinations.
- A valid and clean driver's license is required.
Locations
Worker Type
Worker Sub-Type
Time Type
Full time
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Madrid, Madrid, España Takeda A tiempo completoPosition Overview JOB FUNCTION: This role is primarily dedicated to delivering technical assistance in the execution and management of local studies aimed at generating data in epidemiology and Real World Evidence (RWE) research. The incumbent will ensure compliance with local regulations and legislation to facilitate high-quality implementation of...
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Madrid, Madrid, España Takeda A tiempo completoPosition Overview JOB FUNCTION: This role is primarily dedicated to delivering technical assistance in the execution and management of local studies aimed at generating data in epidemiology and Real World Evidence (RWE) studies. The incumbent will maintain a thorough understanding of relevant legislation and local regulations to ensure high-quality...
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