Trabajos
>
Madrid

    Clinical Operations and Medical Publications Specialist - Madrid, España - Takeda

    Takeda
    Takeda Madrid, España

    hace 2 semanas

    Default job background
    De jornada completa
    Descripción

    Description

    JOB FUNCTION:

    Primarily focused on providing technical support in activities related to the development and implementation of local Studies for the generation of data in epidemiology and Real World Evidence studies (RWE). Maintain knowledge in legislation and local regulation for doing a quality implementation of these studies in support to Therapeutic Area Head and in collaboration with the Clinical Operations Coordinator.

    With the supervision of the Head of Evidence and Value Generation and in close collaboration with Local Medical Area Teams, the incumbent supports medical publications and communications activities.

    ACCOUNTABILITIES:

    Evidence Generation:

  • Operational support and follow-up of local epidemiological and RWE clinical studies (Company Sponsored Studies, Collaborative Clinical Research, Investigator Initiated Research) in collaboration with Local Clinical Operations Coordinator and TA Medical team:Start–up activities,Administrative tasks for getting corresponding internal and external approvals/authorizations,Contracts management,CROs oversight.
  • Ensure alignment with Takeda procedures and local legislation in order to ensure the quality of the investigational projects.
  • Identification of appropriate study sites in collaboration with TA Medical team.
  • Keep up to date local and international Studies databases.

    • Medical Publications:

  • Collaborates with local medical affairs, medical publications agencies and external authors to ensure the execution of the global publication plan.
  • Identify, select, and manage 3rd-party providers and independent contractors to ensure the timely delivery of quality publications and the efficient execution of the tactical plan according to Takeda Standards, SOPs, and related good publication practices guidelines.
  • Manage specific publication project budget and contracts.
  • Coordination of and support to the internal and external review/approval publication process according to Takeda's Global Publication Standard, SOP, and applicable practice guidelines.
  • Track local publications metrics and provide reports to Head of Evidence and Value Generation as required.

    • Takeda Principles and Standards:

  • Act according to Compliance, Ethical codes and Legal standards.
  • Ensure that Patient-Trust-Reputation-Business (PTRB) principles guide the planning and decision-making process. Promote, encourage and demonstrate commitment to Takeda-ism philosophy and values acting as role model driving a culture of integrity and speak up.
  • Communicate to pharmacovigilance department any adverse reaction at the time of becoming aware of it, following company's internal procedures

    • EDUCATION, EXPERIENCE, SKILLS, KNOWLEDGE

    Education:

  • University degree in Medical Health or Biological Sciences.

    • Experience:

  • Previous or current student in Postgraduate Pharmaceutical industry course.
  • Previous experience in pharmaceutical industry in the area of Clinical Operations is valued.
  • Scientific background allowing good understanding of clinical trial data and study design.
  • Experience and knowledge of clinical trial reports, data presentation, and interpretation.
  • Familiarity with regulatory and legal guidelines regarding publication planning, strategy and execution.

    • Skills:

  • Demonstrable thirst for knowledge (technical, clinical, medical, scientific) with an ability to assimilate information quickly; present clinical data clearly and concisely).
  • IT skills (Microsoft Word, Excel and PowerPoint).

    • Knowledge:

  • In-depth knowledge of the applicable GXP regulations, Good Clinical Practices, ICH Guidelines and National Code of Practice.
  • Understands the overall audit process including design, conduct and reporting.
  • Thirst for technical, clinical, medical and scientific knowledge (Desirable).

    • Takeda Core Capabilities.

    Takeda Leadership Behaviors :

  • Clear demonstration of our leadership behaviors, as this is crucial for success in our organization: Think Strategically, Inspire Others, Deliver Priorities, Elevate Capabilities.

    • Digital Knowledge:

  • Upskilling on everyday digital tools and platforms relevant to the position, including artificial intelligence (Eg. CRM, Portals, PowerBI) to boost efficiency, effectiveness, and excellence.

    • Data-Driven Decision Making:

  • Proficiency in using facts, metrics, and data to guide business decisions adjusted to the role and to leverage insights for strategic planning.
  • Clarity on data sources, management and analysis relevant to the role.

    • Agility and Adaptability:

  • Ability to adapt quickly to change and embrace new business models, priorities and digital mindset.
  • Drive for results. Result-oriented and able to develop plans/solutions and deliver expected results even in ambiguous circumstances.
  • Increase efficiency and scalability by repurposing successful elements of existing solutions in the company.

    • Collaborative Mindset:

  • Embracing a collaborative approach to problem-solving and innovation.

    • Continuous Learning:

  • Embrace a life-long learning mindset and take ownership of learning journey, be proactive and build own development planning.
  • Commitment to staying updated with the latest market trends, digital technologies, and best practices in the pharmaceutical industry.

    • PHYSICAL DEMANDS:

  • Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
  • Ability to drive or fly to attend meetings, audits, and training.

    • TRAVEL REQUIREMENTS:

  • Willingness to travel, be away from home (large geographic territory and central briefings) and international destinations
  • Valid and clean driver's licence.

    • Locations

    Madrid, Spain

    Worker Type

    Employee

    Worker Sub-Type

    Regular

    Time Type

    Full time
  • Takeda Pharmaceuticals

    Clinical Operations and Medical Publications Specialist

    hace 2 semanas

    Takeda Pharmaceuticals Madrid, España Paid Work

    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I sub ...

  • Takeda

    Clinical Operations and Medical Publications Specialist

    hace 2 semanas

    Takeda Madrid, España

    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I subm ...

  • Red Hat Software

    Cloud Services Architect

    hace 6 días

    Red Hat Software Madrid, España

    About the job: · We're building a specialized global Black Belt Sales team to improve the go-to-market strategy through Red Hat Managed OpenShift offerings on Amazon Web Services (AWS), Microsoft Azure, and other public clouds. · As a senior member of the EMEA (Europe, Middle Eas ...

  • Boston Consulting Group

    Research Analyst

    hace 3 semanas

    Boston Consulting Group Madrid, España

    **WHAT YOU'LL DO**: · As a Research Analyst within BCG's Data & Researcher Services team, you would provide secondary research in support of proposals, client cases, and business or IP development initiatives, with specialization in Public Sector. You will be responsible for deli ...

  • Airbnb

    Deputy Campaign Lead, Southern Europe

    hace 1 semana

    Airbnb Madrid, España

    Airbnb was born in 2007 when two Hosts welcomed three guests to their San Francisco home, and has since grown to over 4 million Hosts who have welcomed more than 1 billion guest arrivals in almost every country across the globe. Every day, Hosts offer unique stays and experiences ...

  • Doctor Connect

    General Practitioner

    hace 2 semanas

    Doctor Connect Madrid, España

    Rural Medicine on the outskirts of Perth | DPA | Australia's sunniest capital · - High GP earnings available | Relocation support available · - Spanish "Specialist In Family And Community Medicine" are encouraged to apply · **OPPORTUNITY** · There are jobs available at several Ge ...

  • ICF

    Research Assistant or Analyst

    hace 6 días

    ICF Madrid, España

    **Job Description**: · - ICF provides research and expert advice that helps Europe address the key issue of our time, from public health to climate change, education to migration, gender equality to innovation. Much of this work is delivered through large framework contracts with ...

  • Verian (formerly Kantar Public)

    Administrator & Finance Officer

    hace 1 semana

    Verian (formerly Kantar Public) Madrid, España

    **Administrator & Finance Officer** · **Verian Spain** · **Hybrid working**: 3 days a week in the office, 2 days working from home · **Verian **works with clients around the world, providing evidence, insights and advisory services to inspire the next generation of public policy ...

  • ICF

    Analyst - Public Policy

    hace 1 semana

    ICF Madrid, España

    ICF provides research and expert advice that helps Europe address the key issue of our time, from public health to climate change, education to migration, gender equality to innovation. Much of this work is delivered through large framework contracts with the European Commission. ...

  • Arup

    Senior Environmental Consultant

    hace 2 semanas

    Arup Madrid, España

    **About Arup** · Arup is an independent company of engineers, architects, designers, consultants, and technical specialists offering a wide range of professional services. · It is the creative force behind some of the most important and innovative projects in today's-built enviro ...

  • Hitachi Energy

    Market Manager High Voltage Products Spain 80-100%

    hace 1 semana

    Hitachi Energy Madrid, España

    Hitachi Energy, High Voltage Products, is renowned worldwide as a specialist for power transmission and distribution. Our team of specialists in High Voltage Power Products based in Madrid Spain. · Seize this exciting opportunity as our **Market Manager High Voltage Products Spai ...

  • Nurun

    Project Manager Intern

    hace 2 semanas

    Nurun Madrid, España

    **Company Description**: · **Human understanding is our turbine.** · Nurun is the global design and technology consultancy within **Publicis Groupe**, that creates products, services and platforms for a connected world, grounded in state-of-the-art of data science. · This is what ...

  • Cloudera

    Account Executive

    hace 6 días

    Cloudera Madrid, España

    Business Area: · Sales · **Job Description**: · Cloudera Sales empowers the world's largest enterprises across every industry to use data to solve some of the most complex challenges that · impact businesses, · communities · and · lives · - We have a platform that delivers incred ...

  • Hitachi Energy

    Global Pricing Manager

    hace 1 semana

    Hitachi Energy Madrid, España

    **At Hitachi Energy our purpose is advancing a sustainable energy future for all. We bring power to our homes, schools, hospitals and factories. Join us and work with fantastic people, while learning and developing yourself on projects that have a real impact to our communities a ...

  • Thermo Fisher Scientific

    Sr. Medical Writer

    hace 2 semanas

    Thermo Fisher Scientific Madrid, España

    **SENIOR MEDICAL WRITER (PUBLICATIONS) - EVIDERA** · - **We are looking to fill this role in the UK, some EMEA locations or N.A** · The Publications and Scientific Communications team, a part of Medical Writing and Healthcare Communications at Evidera, prepares medical publicatio ...

  • Allucent

    Clinical Trial Associate Ii

    hace 2 semanas

    Allucent Madrid, España

    Allucent is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, an ...

  • Hollis Global

    Mep Design Engineer

    hace 2 semanas

    Hollis Global Madrid, España

    **Salary**: Generous salary + benefits · **Location**: Madrid · **Contract Type**: Permanent · **The Vacancy** · Due to continued growth, we have an exciting opportunity for an energetic and driven Intermediate/Senior Engineer to support the MEP Projects/Building Services team in ...

  • Veeam Software

    Territory Manager

    hace 2 semanas

    Veeam Software Madrid, España

    The Territory Manager will be responsible for developing/closing business indirectly with a number of customers in their assigned market territory through working with the partner sales community. The primary focus is aimed at closing sales opportunities and is achieved by collab ...

  • Edelman

    Account Manager

    hace 2 semanas

    Edelman Madrid, España

    Edelman is the world's largest communications marketing agency with 4,500+ professionals across 65 offices worldwide. Since it was founded in 1952 it remains independent and family-owned. The UK & Ireland offices boast more than 550 people with specialist expertise, including bra ...

  • Veeam Software

    Territory Manager

    hace 2 semanas

    Veeam Software Madrid, España

    The Territory Manager will be responsible for developing/closing business indirectly with a number of customers in their assigned market territory through working with the partner sales community. The primary focus is aimed at closing sales opportunities and is achieved by collab ...