Urwah Admin

Astellas

Algemene informatie
 
Vacatureadvertentie
 
Executive Assistant to the General Manager
 
Locatie
 
Turkije
 
Functie/Business Area
 
Administration
 
Werkcategorie
 
Arbeidsovereenkomst voor onbepaalde tijd
 
Functiebeschrijving
 
Personal Assistant
 
About Astellas: 
At Astellas we are a progressive health partner, delivering value and outcomes where needed.
 We pursue innovative science, focusing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions.
 We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage.
 Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.
 We work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes.
 Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care.
 
The Opportunity: 
As an Executive Assistant at Astellas Pharma, you will play a pivotal role in supporting the General Manager Turkey with daily administrative duties. You will act as a liaison between the General Manager and LT (Leadership Team) as well as other internal/external stakeholders.
 Your contributions will be essential in managing an active calendar of appointments, coordinating complex travel plans, and ensuring seamless communication within the organization. You will be part of a team dedicated to improving lives through innovative healthcare solutions, and your work will directly impact our mission to "Change Tomorrow™."
 
Hybrid Working: 
At Astellas, we recognize the importance of balancing your work and home life. This role offers a remote working solution so you can optimize the most productive work environment for you to succeed and deliver.
 
Key Responsibilities: 
Assist the General Manager Turkey with daily administrative tasks, including managing calendars and preparing expense reports.
 Coordinate virtual meeting platforms, ensure online file organization, and manage access to shared digital resources.
 Be the contact for communication topics or Turkey organization and GM posts and lead the process. Facilitate internal communications.
 Coordinate internal events and activities, such as town halls, seasonal celebrations, and employee engagement initiatives, ensuring alignment with company culture and objectives.
 Draft reports, presentations, and meeting minutes as needed for executive communication
 Organize and manage all aspects of travel logistics, including ticketing, accommodation, and itineraries.
 Oversee and coordinate office logistics, building facility management.
 Occupational Health and Safety responsibilities.
 
Essential Knowledge & Experience: 
Proven experience in executive assistance, office coordination, or similar administrative roles.
 Strong multitasking, organizational, and time management skills.
 Strong proficiency in MS Office and virtual collaboration tools.
 Analytical, detail-oriented with the ability to manage complex tasks.
 Quick learner with a sharp, results-oriented approach.
 Experience coordinating cross-functional teams and liaising with senior stakeholders.
 Discretion and confidentiality in handling sensitive information.
 Fluency in written and spoken business English.
 
Preferred Experience: 
Familiarity with compliance and regulatory requirements in the healthcare sector.
 
Education: 
Bachelor’s degree, or equivalent.
 
Additional Information: 
This is a permanent, full-time position.
 Location: This position is based in Istanbul, Türkiye.
 This position follows our hybrid working model. Role requires a blend of home and a minimum of 3 days per week in our Istanbul office. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of the office.
 We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
 Beware of recruitment scams impersonating Astellas recruiters or representatives. Authentic communication will only originate from an official Astellas LinkedIn profile or a verified company email address. If you encounter a fake profile or anything suspicious, report it promptly to LinkedIn's support team through LinkedIn Help.
 #LI-Istanbul #LI-Hybrid #LI-MO1

Executive Assistant to the General Manager

<div>Purpose and Scope:
<ul><li>The Technical Designer (TD) works as part of a project team to develop specification requirements, implement and maintain Medidata Rave clinical databases and system used to collect, review and clean data in Astellas&rsquo;s phase 1-IV clinical trials.
</li><li>To translate functional requirements into detailed technical specifications that database programmers can implement.
</li><li>Ensure technical feasibility, scalability, and alignment with organization level standards.
</li><li>Act as a liaison between Database Programmers, Data Managers and clinical teams ensuring clarity and consistency.
</li><li>The Technical Designer (TD) will actively search for solutions which reduce set-up times including increased automation of the set-up and will take a leading role in evaluation or improvement projects regarding data management applications or interfaces between data management systems and other applications.
</li><li>Development and improvement of standards, templates, and process to improve efficiency and quality of databases/database set-up is expected along with a level of technical expertise that evokes innovation.
</li></ul>Responsibilities and Accountabilities : 
Technical:
<ul><li>Lead and manage study setup activities for multiple studies of varying complexity, adhering to established processes, standards, and timelines.
</li><li>Designs, develop specifications, and tests clinical databases, including forms, folders, matrices, data dictionaries, unit dictionaries, edit checks, derivations, and custom functions.
</li><li>Provides study-level support to teams and junior team members, assessing the protocol, evaluating alternatives, and facilitating resolution.
</li><li>Creates, reviews, and approves technical specifications for data management systems.
</li><li>Supports databases build specification development, including eCRFs, change requests, edit checks, custom functions, derivations, interface configuration, and migrations.
</li><li>Help resolve metadata anomalies and quality issues.
</li><li>Contributes to the creation of departmental documentation, such as training materials and process guides.
</li><li>Continuously seeks improvements in processes and templates to enhance operational efficiency.
</li><li>Oversee the activities of CRO vendors for outsourced data management systems, ensuring compliance with Astellas and industry best practices and timelines.
</li><li>Maintains regular communication with CRO staff, addressing questions, resolving issues, and mitigating risks.
</li><li>Provides expert-level technical guidance to junior team members, ensuring the delivery of high-quality results.
</li><li>Identifies and communicates lessons learned, best practices, and frequently asked questions.
</li><li>Maintains supporting documentation for studies and systems, ensuring quality, traceability, and compliance.
</li><li>Helps end users understand challenges and analyzes current processes to ensure context, implications, and expectations are clearly represented in the final solution.
</li></ul>Quantitative Dimensions: Oversees the development and maintenance of 18-20 studies per year.</div>
 <div>Required Qualifications: 
 
<ul><li>Bachelor&rsquo;s degree in computer science or a related field, with at least 8 years of experience in the pharmaceutical industry.
</li><li>A minimum of 4 years of experience in clinical trial database design and management, specifically with EDC systems such as Medidata Rave, including experience with Rave EDC
</li><li>Strong proficiency in protocol analysis and interpretation, with the ability to accurately transcribe eCRF specifications from protocol.
</li><li>Expertise in protocol schema mapping to database structures, ensuring accurate representation of study design elements such as arms, cohorts, visits, and endpoints.
</li><li>Expertise in eCRF design, specifications development, and Data Validation Specifications (DVS) to ensure accuracy, compliance, and operational efficiency.
</li><li>Deep understanding of therapeutic areas, including study objectives and endpoints.
</li><li>Expertise in primary and secondary endpoints, Schedule of Activities (SOA), and safety data requirements, ensuring accurate representation in database design and compliance with protocol specifications.
</li><li>Ability to manage screen review presentations, communicate effectively with cross-functional teams, and explain specifications prior to database build.
</li><li>Proven ability to lead technical discussions, provide strategic input on database design, and collaborate with clinical, data management, and programming teams.
</li><li>Skilled in stakeholder communication, including presenting complex technical concepts in a clear and concise manner.
</li><li>Proficiency in test case creation for CRF UAT, Data Flow UAT, and Edit Check UAT, ensuring thorough validation and compliance.
</li><li>Familiarity with QC, UAT, platform testing, and creating and executing test scripts.
</li><li>Strong verbal and written communication skills, with the ability to collaborate effectively across multiple disciplines and regions.
</li><li>Strong organizational skills and the ability to prioritize work to meet deadlines.
</li><li>Excellent interpersonal and project management skills, with the ability to collaborate effectively with individuals at all levels and from diverse backgrounds.
</li></ul>Preferred Qualification:
<ul><li>Familiarity with other Medidata modules (e.g., CTMS, RTSM, TSDV, Coder, Lab Admin) and their integrations.
</li><li>Understanding of relational databases and data capture standards (e.g., CDSIC/CDASH).
</li><li>Advanced computer skills, including proficiency in MS Office (Word, PowerPoint, Excel, Outlook), with the ability to manage complex data analysis and pivot tables.
</li><li>Strong quantitative and analytical skills, with excellent critical thinking and problem-solving abilities.
</li><li>Ability to manage multiple technical projects and provide training to team members.
</li><li>Capacity to learn new technologies quickly and disseminate information effectively.
</li><li>Ability to innovate and transform current industry practices into more efficient solutions.
</li><li>Expertise in providing subject matter expertise, training, and mentoring to team members.
</li><li>Ability to lead discussions on best practices and facilitate input from team members.
</li><li>Ability to work independently and creatively within a collaborative, complex team environment.
</li><li>Experience in CRF Completion Instruction (CCI) document creation and maintenance.
</li><li>Proven ability to handle databases for complex protocols involving multiple cohorts, parts, or adaptive designs, including handling dynamic visit schedules and conditional logic.
</li><li>In-depth understanding of the Drug Development Process, Software Development Life Cycle, Computer Validation Process, FDA regulations, ICH-GCP, and other relevant Health Authority Guidelines.
</li><li>Solid understanding of database structures, programming languages, and integration of external data sources (e.g., IRT, RTSM, lab data, imaging, eCOA, safety systems).
</li><li>Experience with Agile methodologies in clinical research and database development.
</li><li>Ability to identify and mitigate risks in database design and implementation.
</li><li>Experience in managing studies across multiple regions and therapeutic areas.
</li><li>Experience in writing, programming, or configuring data validation checks.
</li></ul>Working Environment 
Astellas&rsquo; Global Capability Centres (GCCs) are strategically located sites that give Astellas the ability to access talent across various functions in the value chain and to co-locate core capabilities that are currently dispersed. Our three GCCs are located in India, Poland and Mexico. 
The GCCs will enhance our operational efficiency, resilience and innovation potential, enabling a timely response to changing business demands. 
Our GCCs are an integral part of Astellas, guided by our shared values and behaviors, and are critical enablers of the company&rsquo;s strategic priorities, sustainable growth, and commitment to turn innovative science into VALUE for patients.</div>

Database Programming Manager

Join Astellas and explore 2   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Astellas

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Executive Assistant to the General Manager

Database Programming Manager