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regulatory affairs executive

regulatory affairs manager Jobs in Istanbul

regulatory affairs manager

medical science liaison

AbbVie

<div>
 
 Company Description
 
 
 
 AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas &ndash; immunology, oncology, neuroscience, and eye care &ndash; and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
 
 
 
 Job Description
 
 
 
 
 We are looking for team members who are located Istanbul or Ankara.
 
 
 
 <ul>
 <li>
 Provide scientific and technical leadership to ensure professional and credible relationships with thought leaders and external experts of strategic importance to AbbVie.
 </li>
 <li>
 Ensure a strong medical and scientific presence for AbbVie in key academic centers by facilitation of research and educational initiatives, while supporting requests for medical and scientific information on products or areas of therapeutic interest to AbbVie.
 </li>
 <li>
 Support internal teams such as sales and marketing and members of the Affiliate Brand Team to develop their scientific and technical expertise through the delivery of scientific up-to-date presentations. Work collaboratively and cross-functionally with other in-field members while retaining functional independence.
 </li>
 <li>
 Attend relevant scientific meetings and Conferences. Collaborate with internal stakeholders to develop summaries of key data and other scientifically relevant information to inform AbbVie strategic priorities and initiatives.
 </li>
 <li>
 Develop and maintain collaborative relationships with thought leaders in the product / therapeutic area for which the MSL has been assigned responsibility, to facilitate AbbVie research and educational priorities and strategic initiatives.
 
 
 </li>
 </ul>
 
 Qualifications
 
 
 
 <ul>
 <li>
 University degree in Medicine or Pharmacy,
 </li>
 <li>
 Previous experience in academy and/or pharma industry would be an asset
 </li>
 <li>
 Fluency in English,
 </li>
 <li>
 Experience in developing and maintaining expert knowledge for the assigned therapeutic area, and in medical research in general,
 </li>
 <li>
 Solid knowledge of the pharmaceutical environment and the role of Medical Affairs to advance the medical and scientific objectives of a pharmaceutical company,
 </li>
 <li>
 Demonstrated expertise in the scientific methods applied to clinical research and current legislative/regulatory controls applicable to this research.
 
 
 </li>
 </ul>
 Additional Information
 
 
 AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.
 
 
 US &amp; Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
 
 
 US &amp; Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
 
 
 https://www.abbvie.com/join-us/reasonable-accommodations.html
</div>

Medical Science Liaison

<div>Company Description 
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas &ndash; immunology, oncology, neuroscience, and eye care &ndash; and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. 
Job Description 
 We are looking for team members who are located Istanbul or Ankara.<ul><li>
Provide scientific and technical leadership to ensure professional and credible relationships with thought leaders and external experts of strategic importance to AbbVie.</li><li>
Ensure a strong medical and scientific presence for AbbVie in key academic centers by facilitation of research and educational initiatives, while supporting requests for medical and scientific information on products or areas of therapeutic interest to AbbVie.</li><li>
Support internal teams such as sales and marketing and members of the Affiliate Brand Team to develop their scientific and technical expertise through the delivery of scientific up-to-date presentations. Work collaboratively and cross-functionally with other in-field members while retaining functional independence.</li><li>
Attend relevant scientific meetings and Conferences. Collaborate with internal stakeholders to develop summaries of key data and other scientifically relevant information to inform AbbVie strategic priorities and initiatives.</li><li>
Develop and maintain collaborative relationships with thought leaders in the product / therapeutic area for which the MSL has been assigned responsibility, to facilitate AbbVie research and educational priorities and strategic initiatives.</li></ul> 

Qualifications 
<ul><li>
University degree in Medicine or Pharmacy,</li><li>
Previous experience in academy and/or pharma industry would be an asset</li><li>
Fluency in English,</li><li>
Experience in developing and maintaining expert knowledge for the assigned therapeutic area, and in medical research in general,</li><li>
Solid knowledge of the pharmaceutical environment and the role of Medical Affairs to advance the medical and scientific objectives of a pharmaceutical company,</li><li>
Demonstrated expertise in the scientific methods applied to clinical research and current legislative/regulatory controls applicable to this research.</li></ul> 

Additional Information<div></div> 
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US &amp; Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US &amp; Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html</div>

Exeltis Turkey

<div>
 
 
 Medical Manager
 
 
 
 
 
 
 We are looking for a Medical Manager to be assigned to our Head Office at Exeltis Turkey.
 
 
 
 
 
 
 Qualifications
 
 
 <ul>
 <li>
 Medical Doctor (MD) degree,
 </li>
 <li>
 Excellent command of written and spoken English,
 </li>
 <li>
 Proficient in MS Office applications and effective presentation techniques,
 </li>
 <li>
 Strong sense of responsibility with analytical and strategic thinking skills,
 </li>
 <li>
 Holder of a valid B-class driving license and actively driving,
 </li>
 <li>
 No restrictions on travel.
 </li>
 <li>
 Experience in Respiratory Field will be preferred
 </li>
 </ul>
 
 
 
 
 
 Job Description
 
 
 <ul>
 <li>
 Providing continuous medical update and support for existing products,
 </li>
 <li>
 Represent the company at Scientific Congresses, trainings, and medical meetings,
 </li>
 <li>
 Provide medical support to Marketing and Sales teams during scientific presentations,
 </li>
 <li>
 Contribute medical insights to product strategies,
 </li>
 <li>
 Conduct meetings with key opinion leaders (KOLs) and Health Authorities regarding assigned products,
 </li>
 <li>
 Plan, initiate, and monitor clinical research activities,
 </li>
 <li>
 Oversee pharmacovigilance operations and ensure the pharmacovigilance system remains compliant with current regulatory requirements
 </li>
 </ul>
 
 
</div>

Medical Manager

Trispera Pharma Solutions

<div>
 
 
 Who We Are
 
 
 
 
 
 
 Trispera is a dynamic medical affairs and pharmaceutical distribution company based in Istanbul, T&uuml;rkiye, with a dedicated focus on rare diseases. As a young and agile start-up, we are committed to ethical business practices and value development-driven collaboration.
 
 
 
 
 
 
 Job Description
 
 
 
 
 
 
 We are seeking a Medical Doctor or Pharmacist with proven experience as a Regional Medical Manager to join our growing team. The successful candidate will play a pivotal role in leading our medical affairs operations in the field of rare diseases.
 
 
 
 
 
 
 Key Responsibilities
 
 
 
 
 
 
 &bull; Act as the primary point of contact for healthcare professionals (HCPs), ensuring clear, consistent, and effective communication with all external stakeholders. Establish and maintain trusted scientific partnerships through regular, high-quality medical interactions. This is a field-based role, requiring regular on-site interactions with HCPs three days per week.
 
 
 &bull; Provide up-to-date and relevant scientific and product information to key opinion leaders and the broader medical community to foster clinical confidence and understanding.
 
 
 &bull; Map patient journeys, diagnostic practices, and treatment pathways while developing peer-to-peer relationships with relevant HCPs.
 
 
 &bull; Organize and participate in medical meetings, advisory boards, and congress-related engagements.
 
 
 &bull; Develop and implement scientific communication strategies. Support the creation and review of publications in alignment with the company&rsquo;s scientific narrative.
 
 
 &bull; Review medical communication tools, educational resources, and promotional materials for scientific accuracy and regulatory compliance.
 
 
 &bull; Effectively communicate the medical value of the company&rsquo;s products to both internal and external stakeholders.
 
 
 &bull; Identify educational gaps among HCPs and deliver scientific, non-promotional presentations to address those needs.
 
 
 
 
 
 
 Qualifications and Skills
 
 
 
 
 
 
 &bull; MD or PharmB degree,
 
 
 &bull; Minimum 5 years of experience in the pharmaceutical industry (preferred),
 
 
 &bull; Minimum 2 years of experience in the field of rare diseases (preferred),
 
 
 &bull; Background in endocrinology, metabolism, oncology, or hematology (preferred),
 
 
 &bull; Experience in start-up environments or adaptability to fast-paced, agile settings,
 
 
 &bull; Excellent command of both written and spoken English and Turkish,
 
 
 &bull; High level of personal discipline, professionalism, and adherence to ethical standards,
 
 
 &bull; Strong interpersonal and communication skills,
 
 
 &bull; Comfortable working within a matrix management model,
 
 
 &bull; Flexibility with working hours,
 
 
 &bull; Based in Istanbul,
 
 
 &bull; For male candidates: Completion of military service (if applicable).
 
</div>

Regional Medical Manager

AstraZeneca

<div>Onkoloji alan&#305;nda tutkuyla &ccedil;al&#305;&#351;an ekibimizin bir par&ccedil;as&#305; olun!
AstraZeneca T&uuml;rkiye Onkoloji &#304;&#351; Birimi olarak, bilimi takip ediyor, ihtiyac&#305; olan hastalara yenilik&ccedil;i tedaviler ula&#351;t&#305;rmak i&ccedil;in var g&uuml;c&uuml;m&uuml;zle &ccedil;al&#305;&#351;&#305;yoruz. Amac&#305;m&#305;z, hastalar&#305;n hayat&#305;nda anlaml&#305; bir fark yaratmak ve onkoloji alan&#305;ndaki kar&#351;&#305;lanmam&#305;&#351; ihtiya&ccedil;lara &ccedil;&ouml;z&uuml;m &uuml;retmek. Bu ama&ccedil; do&#287;rultusunda 40 y&#305;ldan uzun s&uuml;redir hedefe y&ouml;nelik tedaviler geli&#351;tirmek i&ccedil;in bilimin s&#305;n&#305;rlar&#305;n&#305; zorluyoruz.
AstraZeneca ailesi olarak her birimiz hayatlar&#305; iyile&#351;tirecek sonu&ccedil;lar geli&#351;tirmek i&ccedil;in heyecanla &ccedil;al&#305;&#351;&#305;yoruz. S&uuml;rekli daha fazlas&#305;n&#305; ve daha iyisini arayarak s&uuml;rekli geli&#351;en ve de&#287;i&#351;en hayat&#305;m&#305;zda her zaman ba&#351;ar&#305;l&#305; oluyoruz.
Genel Nitelikler<ul><li>
4 y&#305;ll&#305;k &uuml;niversite mezunu</li><li>
&Uuml;niversitelerin Fen Bilimi b&ouml;l&uuml;mlerinden mezun veya ila&ccedil; sekt&ouml;r&uuml;nde Onkoloji alan&#305;nda deneyime sahip</li><li>
&#304;yi derecede medikal bilgisi olan</li><li>
B s&#305;n&#305;f&#305; s&uuml;r&uuml;c&uuml; belgesine sahip ve aktif g&uuml;venli ara&ccedil; kullanabilen</li><li>
Seyahat engeli olmayan</li><li>
Erkek adaylar i&ccedil;in askerlik hizmetini tamamlam&#305;&#351;</li><li>
3/7/2015 tarihli ve 29405 say&#305;l&#305; Resmi Gazete'de yay&#305;mlanan Be&#351;eri T&#305;bbi &Uuml;r&uuml;nlerin Tan&#305;t&#305;m Faaliyetleri Hakk&#305;nda Y&ouml;netmelik'in 10. Maddesinde belirtilen &Uuml;TT yeterlilik belgesini almaya hak kazanm&#305;&#351; olmak ve bireysel &Uuml;TT Karekoduna sahip olmak.</li></ul>
&#304;&#351; Tan&#305;m&#305;<ul><li>
Sorumlu oldu&#287;u sa&#287;l&#305;k &ccedil;al&#305;&#351;anlar&#305;na y&ouml;nelik bilimsel tan&#305;t&#305;m faaliyetleri ger&ccedil;ekle&#351;tirmek ve gerekli medikal bilgileri aktarmak</li><li>
Sa&#287;l&#305;k &ccedil;al&#305;&#351;anlar&#305;na, &uuml;r&uuml;nlerin resmi otoritelerce onaylanm&#305;&#351; endikasyonlar&#305; kapsam&#305;nda &uuml;r&uuml;n tan&#305;t&#305;m&#305;n&#305; yapmak ve &uuml;r&uuml;nlerin yayg&#305;n olarak bilinirli&#287;ini sa&#287;lamak</li><li>
Sorumlu olunan kilit &uuml;niteler i&ccedil;in yenilik&ccedil;i projeler geli&#351;tirmek</li><li>
Doktor Grup Aktivitesi, Eczane Grup Aktivitesi, &Uuml;r&uuml;n Bilgilendirme Yeme&#287;i, N&ouml;bet Sunumu, e-tan&#305;t&#305;m, numune da&#287;&#305;t&#305;m&#305;, g&ouml;rsel malzeme &ccedil;al&#305;&#351;malar&#305; y&uuml;r&uuml;terek, belirlenen hedefler &ccedil;er&ccedil;evesinde tan&#305;t&#305;m tekniklerini hekim ve eczane ziyaretlerinde uygulamak</li><li>
Eczaneleri tan&#305;t&#305;m kampanyalar&#305; hakk&#305;nda bilgilendirmek, &uuml;r&uuml;nlerin eczanelerdeki t&uuml;ketimlerini ve stoklar&#305;n&#305; takip etmek</li><li>
Belirlenen hedef ve stratejiler do&#287;rultusunda, ilgili platformlarda AstraZeneca&rsquo;y&#305; temsil etmek</li></ul>
Neden AstraZeneca?
Cevaplanmam&#305;&#351; sorular&#305; ele al&#305;p yenilikler yaparak, kabul g&ouml;ren normlara meydan okuyarak, h&#305;zl&#305; kararlar vererek ve ak&#305;ll&#305; riskler alarak &ccedil;al&#305;&#351;&#305;yoruz.
Sa&#287;l&#305;&#287;&#305;n gelece&#287;ini daha iyi noktalara ta&#351;&#305;yabilmek i&ccedil;in heyecan verici bir yolculuktay&#305;z. Hastalar&#305;n hayat&#305;nda, toplumda ve t&#305;pta fark yaratmak i&ccedil;in en iyi i&#351; yerlerinden biri buras&#305;!
Daha fazla bilgiyi nereden bulabilirim?
AstraZeneca'y&#305; LinkedIn'de takip edin https://www.linkedin.com/company/1603/
AstraZeneca'y&#305; Instagram'da takip edin - https://www.instagram.com/astrazenecaturkiyekariyer</div>

Ürün Tanıtım Uzmanı - Onkoloji İstanbul Anadolu (Dönemsel-6 Ay)

Consulta

<div>
 
 
 We Are Hiring:
 
 Third Part Manufacturer and Technical Transfer QA Manager&ndash; EMEA
 
 
 
 
 
 
 
 &ldquo;On behalf of our global business partner operating in the healthcare sector, we are reaching out to qualified candidates for the Third Party Manufacturer and Technical Transfer QA Manager &ndash; EMEA (Istanbul) position. This role is responsible for TPM (Third Party Manufacturer) management across the EMEA region, overseeing technical transfer processes, and providing quality assurance support particularly for biosimilar product transfer projects.&rdquo;
 
 
 
 
 
 
 
 Regional TPM Quality:
 
 
 
 
 
 
 <ul>
 <li>
 Primary responsible for Quality management related to TPM in the EMEA region, for delivering quality products through reliable supply chain.
 </li>
 <li>
 Responsible of Monitoring TPM quality performance.
 </li>
 <li>
 Primary lead for Quality Technical Agreements approval renewal
 </li>
 <li>
 Primary contact for communication of TPM Quality issues as needed.
 </li>
 <li>
 QA support for investigations, trends, complaints, corrective and preventive actions (CAPA), validation support, and product release issues as needed.
 </li>
 <li>
 Responsible for maintaining regional Approved Supplier Listing.
 </li>
 <li>
 Responsible for representing regional TPMs Quality in Management Review.
 </li>
 <li>
 Responsible for communication with Global TPM/Supplier QA regarding Global TPM Products that are supplied
 </li>
 <li>
 Responsible for supporting Global and Regional Quality Compliance and improvement initiatives.
 </li>
 <li>
 Primary QA interface for new contract manufacturing site approvals within region must approve all new contract manufacturers for EPD commercial product within responsibility.
 </li>
 </ul>
 
 
 
 
 
 
 Product Transfer and Support QA
 
 
 
 
 
 
 <ul>
 <li>
 QA Lead for below quality activities during Product Transfer and ASQ including,
 </li>
 <li>
 Change Control / Stability and Change Impact Assessment
 </li>
 <li>
 Test Method Transfer/Analytical Method
 </li>
 <li>
 Validation/Verification
 </li>
 <li>
 Process Validation/Verification Program
 </li>
 <li>
 Stability program during Shelf-Life of the product Microbiological validation studies
 </li>
 <li>
 First lot quality review for release the validation batches for commercialization.
 </li>
 <li>
 Gather information from the Sending Unit, in order to assemble a data package.
 </li>
 <li>
 Evaluate the information gathered and document findings with respect to product robustness
 </li>
 <li>
 Participate to the process of creation, approval and continuous improvement of the regulatory documentation related to EPD products. Provide support for the specification setting to Regulatory Affairs and receiving unit.
 </li>
 <li>
 Provide contributions for the Product technical knowledge during and after technology transfer and ensure the product meeting the Quality Standards. Facilitate issue resolution for key investigation and compliance issues
 </li>
 <li>
 Supporting the lifecycle management strategy and supporting its operational execution as supporting the work-stream team or equivalent cross-functional team. Managing product and process quality and compliance throughout the maturity stage of the life cycle of EPD commercialized products
 </li>
 <li>
 Ensure that projects and technical activities associated with Drug Substances, Drug Products, Intermediates and non-pharma products (food supplement, medical device, cosmetics) are carried out without business interruptions and according to legal and Abbott Quality, Regulatory and business requirements.
 </li>
 <li>
 Liaison between sites QA, commercial affiliates, MS&amp;T (Manufacturing Science and Technology) and other groups as necessary.
 </li>
 <li>
 Conduct/assist in due-diligence audits for new API suppliers to provide a rapid and accurate usage decision on proposed suppliers
 </li>
 <li>
 Serve as quality technical resource of regional EPD Quality organization during process and regulatory deficiency issues, risk assessment target cost initiatives and other continues improvement initiatives.
 </li>
 </ul>
 
 
 
 
 
 
 
 
 
 Required Qualifications
 
 
 
 
 
 
 <ul>
 <li>
 Bachelor's degree in Chemistry, Pharmacy, Medical Science.
 </li>
 <li>
 8+ years of supervisorial experience in the pharmaceutical (Quality, Production, R&amp;D etc.) or related fields.
 </li>
 <li>
 GMP/GLP/GCP background related to Biotechnological, Biosimilars and Biologics, medicinal products.
 </li>
 <li>
 Good communication and report writing skill in English
 </li>
 <li>
 Strong leadership skills in bringing the best out of people, managing work teams and fostering teamwork within the department.
 </li>
 <li>
 Strong strategic Planning/ Thinking, decisive judgement, and Implementation skills.
 </li>
 <li>
 Flexible for Travel: 40 %
 </li>
 </ul>
 
 
</div>

Third Part Manufacturer and Technical Transfer QA Manager(Temporary)

Parexel

<div>Key Accountabilities:<div><div><div><div><div><div><div><div><div>
Site Management Responsibilities<ul><li>
Contributes to the selection of potential investigators.
</li><li>In some countries, as required, Sr CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study.
</li><li>Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles.
</li><li>Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are always inspection ready.
</li><li>Actively participates in Local Study Team (LST) meetings.
</li><li>Contributes to National Investigators meetings, as applicable.</li><li>
Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST.
</li><li>Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate.
</li><li>Updates CTMS and other systems with data from study sites as per required timelines.
</li><li>Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable.</li><li>
Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines and discusses with LSAD the correct timing and type of visits.
</li><li>Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan.
</li><li>Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study.
</li><li>Ensures data query resolution in a timely manner.
</li><li>Works with data management to ensure robust quality of the collected study data.
</li><li>Ensures accurate and timely reporting of Serious Adverse Events and their follow ups.</li><li>
Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with Client SOP.
</li><li>Follows up on outstanding actions with study sites to ensure resolution in a timely manner.
</li><li>Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required.
</li><li>Assists site in maintaining inspection ready ISF.
</li><li>Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD).
</li><li>Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICHGCP, Client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate.
 </li><li>Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF.
</li><li>Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.
</li><li>Collaborates with local Medical Scientific Liaisons (MSLs) as directed by LSAD or line manager</li></ul>
Compliance with Sponsor Standards<ul><li>
Ensures compliance with the Client&rsquo;s Code of Ethics and company policies and procedures relating to people, finance, technology, security, and SHE (Safety, Health and Environment).</li><li>
Ensures compliance with local, national, and regional legislation, as applicable.
</li><li>Completes timesheets accurately as required</li></ul>
Compliance with Parexel Standards<ul><li>
Complies with required training curriculum.
</li><li>Completes timesheets accurately as required.
</li><li>Submits expense reports as required.
</li><li>Updates CV as required.
</li><li>Maintains working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements.</li></ul>
Skills (Essential):
<ul><li>Excellent attention to detail.
</li><li>Good written and verbal communication skills.
</li><li>Good collaboration and interpersonal skills.
</li><li>Good negotiation skills.
</li><li>Proficient in written and spoken English language required.
</li><li>Fluency in local language(s) required.
</li></ul>Skills (Desirable):
<ul><li>Ability to work in an environment of remote collaborators. Manages change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and add value to the business.
</li><li>Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.
</li><li>Good analytical and problem-solving skills.
</li><li>Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
</li><li>Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment.
</li><li>Team oriented and flexible; ability to respond quickly to shifting demands and opportunities Knowledge and Experience (Essential):
</li><li>Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP. &bull; Good knowledge of relevant local regulations.
</li><li>Good medical knowledge and ability to learn relevant Client Therapeutic Areas.
</li><li>Basic understanding of the drug development process.
</li><li>Good understanding of Clinical Study Management including monitoring, study drug handling and data management.</li></ul>
Knowledge and Experience (Desirable):
<ul><li>Familiar with risk-based monitoring approach including remote monitoring.
</li><li>Good cultural awareness.
</li></ul>Education:
<ul><li>Bachelor&rsquo;s degree in related discipline, preferably in life science, (or equivalent adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers.</li></ul>
Other:<ul><li>
Ability to travel nationally/internationally as required.
</li><li>Valid driving license per country requirements, as applicable</li></ul></div></div></div></div></div></div></div></div></div></div>

Senior Clinical Research Associate & CRAII - FSP (Open)

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Regional Medical Manager

Ürün Tanıtım Uzmanı - Onkoloji İstanbul Anadolu (Dönemsel-6 Ay)

Third Part Manufacturer and Technical Transfer QA Manager(Temporary)

Senior Clinical Research Associate & CRAII - FSP (Open)