Clinical Operations and Medical Publications Specialist

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Job 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.

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