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project manager - ahiboz plant Jobs in Ankara

project manager - ahiboz plant

senior manufacturing - painting engineer Jobs in Ankara

senior manufacturing - painting engineer

senior manufacturing engineer Jobs in Ankara

senior manufacturing engineer

project manager ahiboz plant

Knauf MEASA

<div><p><b>Knauf stands for opportunity</b>. We know that opportunity looks different to each person, and we are proud that we see opportunity in everyone. This exciting role within Ahiboz Plant could be the perfect next opportunity for you to build a unique career, in a values-led culture with a clear purpose of making tomorrow a home for all of us.</p><p>
We are a global manufacturer of construction materials and within our Group, our <b>43,500 team members</b> in <b>98 countries</b> across <b>300 sites</b> provide a huge opportunity for anyone with ambition and energy. We value everyone's contribution equally and we ask that you bring your whole self to work, to enrich the business further, as together we achieve more in a safe and inclusive environment.</p><p>
Knauf T&uuml;rkiye is proud to be part of the Knauf Group. We have a 30-year heritage in high quality, market-leading gypsum building products manufacturing and have big plans for the future. Our global reach in 90 countries continues to grow and we are looking for passionate, ambitious people to help us achieve our goals. We are all led by the same core values and believe in the powerful potential of large companies to have a positive impact on the world. <b>We are now looking for another team mate to join us in Ahiboz Plant as Project Manager.</b></p><p></p><p><b>
Can you say &lsquo;yes&rsquo;?</b></p><p>
Do you treat your colleagues with respect?</p><p>
Do you always have the customer in mind?</p><p>
Do you act with future generations in mind?</p><p>
Do you like to seek out opportunities to grow and develop?</p><p>
Do you have a proven track record of delivering results?</p><p></p><p>
We are seeking a highly experienced Project Manager (Civil Engineer) to lead the upcoming Ahiboz 2 expansion project. This critical investment includes the construction of a new main building, an additional warehouse, full MEP &amp; firefighting infrastructure, and complete integration with our existing plant operations.</p><p><br>
Acting as a direct extension of the Factory Director&rsquo;s office, you will serve as our in-house project lead, eliminating the need for an external project management consultancy. The candidate will coordinate all external contractors, ensure flawless execution, and maintain absolute control over the project&rsquo;s budget, schedule, and quality from tender to final handover.</p><p><b><br>
What you&rsquo;ll be doing:</b></p><p><b>
Phase A: Pre-Construction &amp; Tendering</b></p><ul><li><b>Design Review: </b>Audit all architectural, structural, electrical, and mechanical designs to guarantee compliance with Turkish Building Earthquake Codes (TBDY), Fire Protection Regulations, and local municipality requirements.</li><li><b>Procurement Support: </b>Define detailed Scopes of Work (SOW) for main construction contractors and technically/commercially evaluate incoming bids.</li><li><b>Permit Management: </b>Drive the local permitting process, coordinating directly with the statutory Building Inspection Firm (Yapı Denetim) to keep the Construction Permit (Yapı Ruhsatı) on track.</li></ul><div><b><br>
Phase B: Construction Management &amp; Site Supervision</b><br>
<ul><li><b>Site Leadership: </b>Provide full-time, on-site supervision of all civil, mechanical, and electrical works, acting as the primary interface between plant leadership and external contractors.</li><li><b>Schedule Control: </b>Monitor the master project schedule relentlessly, proactively identifying bottlenecks and deploying immediate mitigation plans.</li><li><b>Quality &amp; Financial Control: </b>Enforce strict QA/QC protocols to ensure all materials and workmanship meet contract specifications. Rigorously review and approve contractor progress payments (hakediş) prior to finance submission.</li><li><b>HSE Leadership: </b>Champion a proactive Health, Safety, and Environment culture on site. Go beyond strict adherence to Law No. 6331 by collaborating with on-site safety specialists to ensure true safety commitment from all contractor personnel.</li></ul></div><div><b><br>
Phase C: Commissioning &amp; Handover</b><br>
<ul><li><b>Systems Integration: </b>Oversee the testing and commissioning of all new MEP systems, ensuring seamless integration with ongoing plant operations without disruption.</li><li><b>Defect Management: </b>Manage and close out the punch-list (defects list), holding contractors accountable for rectifying all issues.</li><li><b>Project Closeout: </b>Collect, organize, and verify all As-Built drawings, operation manuals, and warranties. Lead the bureaucratic process to secure the final Occupancy Permit.</li></ul><b>
Reporting &amp; Communication</b><br>
<ul><li><b>Weekly Dashboards: </b>Produce concise 1-2 page weekly updates highlighting site progress, immediate risks, and safety metrics.</li><li><b>Monthly Executive Reports: </b>Deliver detailed monthly reviews covering budget status, schedule tracking, quality audits, and payment milestones.</li><li><b>Ad-Hoc Escalations: </b>Immediately alert the Factory Director and Process Manager to any critical issues that could threaten ongoing daily plant operations.</li></ul></div><p><b><br>
What we&rsquo;d love for you to have:</b></p><p>
We are interested in you as a person: your attitude, behaviors and values. As long as you have the willingness to learn anything you need for the role that you don't already have, we'd love to speak to you. If you have experience in the following areas &ndash; this is an added advantage:</p><ul><li><p>
Bachelor&rsquo;s Degree in Civil Engineering.</p></li><li><p>
Minimum of 10 years of hands-on site experience in managing industrial construction, factory expansions, or heavy manufacturing projects in Turkiye</p></li><li><p>
Deep, practical understanding of Turkish construction laws</p></li><li><p>
Fluency in Turkish (for seamless local contractor and site management) and advanced English (for reporting and communicating with global engineering stakeholders)</p></li><li><p>
Exceptional leadership presence, strong commercial acumen for managing general contractors, and a zero-compromise attitude toward industrial safety and quality</p></li><li><p>
Knowledge of/ Interested in Lean Management, 5S and Continuous Improvement, digitalization</p></li><li><p>
Working experience in an international environment</p></li><li><p>
Proficiency in Microsoft Office Applications, especially MS Excel</p></li><li><p>
Strong communication skills, teamworking and consumer centric</p></li><li><p>
Excellent command of English both written and spoken</p></li><li><p>
Residency/ to be able to reside in Ankara</p></li></ul><p></p><p><b><br>
What happens next?</b></p><p>
We appreciate that your time is precious and applying for a new job can be a lengthy process - so we have committed to replying to your application as soon as possible.</p></div>

Project Manager - Ahiboz Plant

Henkel

<div><div><h4 class="jobSectionHeader"><b>About this Position</b><b>
</b></h4>Embark on a journey as a Digital Engineer where you will become part of a dynamic work environment, collaborating with diverse colleagues to enhance overall efficiency, problem-solving, and creativity within the workplace. Would you dare to make an impact? This is how:<br>
<br>
<br>
<h4 class="jobSectionHeader"><b>What you&acute;ll do</b><b>
</b></h4><ul><li>Lead digitalization projects aimed at automating processes and integrating smart manufacturing technologies (e.g., IIoT, SCADA, MES, PLC).</li><li>
Implement and maintain digital tools for real-time production monitoring, predictive maintenance, and energy metering management.</li><li>
Collect, clean, and analyze plant data to identify inefficiencies and improvement opportunities.</li><li>
Develop dashboards and reports using tools like Power BI, Tableau, or custom applications.</li><li>
Integrate shop floor systems (e.g., PLCs, sensors, MES) with enterprise systems (e.g., ERP, SAP).
</li><li>Ensure seamless data flow across OT (Operational Technology) and IT systems.</li><li>
Collaborate with cross-functional teams including operations, IT, quality, and supply chain.</li><li>
Research and recommend new digital technologies to enhance production capabilities.</li><li>
Support change management by training plant personnel on new digital tools and processes.
</li></ul><h4 class="jobSectionHeader"><b>What makes you a good fit</b><b>
</b></h4><ul><li>Bachelor&rsquo;s degree in Engineering (Electrical, Automation, or related field).</li><li>
4 to 5 years of experience in manufacturing or digital engineering, preferably in the FMCG industry.</li><li>
Familiarity with industrial automation (PLC, SCADA, HMI systems mainly Siemens).</li><li>
Experience with data analytics and visualization tools (Power BI, Python, Excel, etc.).</li><li>
Knowledge of IIoT, Industry 4.0, and smart manufacturing concepts.</li><li>
Strong problem-solving skills and ability to work in a fast-paced environment.</li><li>
Good communication and project management skills.
</li></ul><h4 class="jobSectionHeader"><b>Some perks of joining Henkel</b><b>
</b></h4><ul><li>Global wellbeing standards with health and preventive care programs</li><li>
Gender-neutral parental leave for a minimum of 8 weeks</li><li>
Employee Share Plan with voluntary investment and Henkel matching shares
</li></ul><p>At Henkel, we come from a broad range of backgrounds, perspectives, and life experiences. We believe the uniqueness of all our employees is the power in us. Become part of the team and bring your uniqueness to us! We look for a diverse team of individuals who possess different backgrounds, experiences, personalities and mindsets.</p></div></div>

Digital Engineer (Ankara Plant)

Eaton

<div><p><b>Temelli (Ankara) | On site<br>
</b></p><p><br>
<b>Why Eaton
</b><br>
At Eaton, we help solve the world&rsquo;s toughest energy challenges. We are a global leader in power management, committed to innovation, sustainability, and inclusive growth. Our people are at the heart of everything we do &mdash; and we invest in their development.<br>
</p><p><br>
<b>About the Site
</b><br>
Our Temelli facility is a fast growing medium voltage center of excellence with over 230 employees. The site manufactures oil type distribution transformers for global customers across utilities, data centers, renewables, mining, and industrial sectors. It is a modern plant with strong automation ambitions and international exposure.<br>
</p><p></p><p><b>The Role
</b><br>
This is a newly created position within our Operational Excellence (OPEX) team, reporting directly to the OPEX Manager. You will play a key role in improving manufacturing processes, supporting new product introductions, and driving automation and Industry 4.0 initiatives, with strong visibility across the plant and leadership team.
</p><div><div><div><h2 class="jobSectionHeader"><b>What You&rsquo;ll Do
</b></h2></div><div><ul><li>Improve and standardize manufacturing processes using Lean, Six Sigma, and TPM
</li><li>Support New Product Introduction (NPI) and industrialization activities
</li><li>Lead continuous improvement and root cause problem solving
</li><li>Drive automation, digitalization, and Industry 4.0 initiatives
</li><li>Evaluate and implement new manufacturing technologies and equipment
</li><li>Work closely with production, quality, and supply chain teams
</li><li>Support audits, reporting, and key operational decision forums
</li></ul></div></div><div><div><h2 class="jobSectionHeader"><b>What We&rsquo;re Looking For
</b></h2></div><div><ul><li>Degree in Mechanical, Electrical, Materials, or Industrial Engineering
</li><li>Strong exposure to painting processes
</li><li>Experience as a Manufacturing / Industrial Engineer in similar environments
</li><li>Exposure to Lean tools and structured problem solving is preferred
</li><li>Comfortable working in a production environment with multiple stakeholders
</li>Fluent English, with openness to international collaboration<br>
<li>
</li></ul></div></div></div><p></p><p><b>What we offer:
</b></p><ul><li>Competitive compensation and benefits package
</li><li>Challenging projects in dynamic collaborative team
</li><li>We make your aspirations matter &ndash; Eaton encourages internal promotion, whenever possible
</li><li>We make your growth matter - We invest in our employees for the long term &ndash; not just with salary and benefits, but with ongoing learning and development opportunities made available through Eaton University
</li><li>We make your contributions matter - reliability, safety, efficiency, and sustainability are at the core of our dedication to improving people&rsquo;s lives and the environment through power management technologies.
</li><li>We make your wellbeing matter &ndash; We put your health and safety first. Wellness at Eaton is more than a program, it&rsquo;s about changing the environment by offering the right tools to help empower employees to make that happen.
</li></ul><p>We are committed to ensuring equal employment opportunities for job applicants and employees. Our recruitment processes use balanced selection criteria and avoid unlawful discrimination against applicants on the basis of their age, colour, disability, marital status, national origin, gender, gender identity, genetic information, race or racial origin, religion, sexual orientation or any other status protected or required by law.<br>
</p><p></p><p>#LI-DG1</p></div>

Senior Manufacturing - Painting Engineer

<div><p>Join Eaton, a global leader where equality and inclusivity are at the heart of our mission. Here, everyone is valued and belongs. Be part of a team that delivers cutting-edge, energy-efficient solutions, making a tangible impact on the world. We empower our customers to manage electrical, hydraulic, and mechanical energy more effectively, safely, and sustainably. At Eaton, we&rsquo;re dedicated to enhancing quality of life and protecting the environment with our innovative energy management technologies and services. Our EMEA Business Service teams empower seamless operations and drive exceptional results across our electrical, industrial, and corporate teams.
</p><div><div><div><h2 class="jobSectionHeader"><b>What you&rsquo;ll do:
</b></h2></div><div><p>The Supply Chain Network Planning Manager is a leading role in the integrated, intelligent and agile supply chain organization, focusing on the full SIOP horizon including execution ( 0-36 months). The Network Planning Manager is responsible for demand-supply balancing for their value stream and providing insights on demand at risk for their respective portfolio. This role focuses on setting and maintaining the guardrails by which the consensus supply plan is generated; taking into consideration constraints, allocation, and prioritization rules for the full horizon, while managing critical exceptions in mid-term.<br>
</p><p></p><p>Main Responsibilities:
</p><ul><li>Manage a team of Network Schedulers/MPS planners responsible for value stream in the 0-3 months window and functionally collaborate with a team of Buyers, Material Planners and Order Managers.
</li><li>Manage capacity vs. demand (0-36 months horizon), flagging any exceptions, driving solutions and decision making to close the gap.
</li><li>Partner with operations, warehousing and operational procurement if capacity gaps require escalation.
</li><li>Manage replenishment strategy across value stream in line with the inventory policy, and conducts regular parameters audits.
</li><li>Create the consensus supply plan, balancing FG inventory and capacity with the objective to meet demand on-time and in full.
</li><li>Ensure production schedule adherence and attainment.
</li><li>Work with SIOP and business teams to update FG inventory targets and inventory policies.
</li><li>Review supply and inventory performance metrics, inventory outlook projection, and identify gaps vs targets &amp; improvement opportunities, and liaise with relevant stakeholders to execute improvement action plans.
</li><li>Be accountable for value stream improvements in cash, cost and customer service results.
</li><li>Initiate scenario planning to optimize the plan on service, cash and costs.
</li><li>Prioritize order allocation in case of supply constraint (affecting more than one market/customer) in collaboration with the Execution Scheduler.
</li><li>Provide relevant information to the divisional SIOP meetings regarding supply vs. demand (capacity) and FG inventory performance
</li></ul></div></div><div><div><h2 class="jobSectionHeader"><b>Qualifications:
</b></h2></div><div><ul><li>Bachelor degree or preferably MBA/Masters in Supply Chain/Operations or Engineering
</li>8+ years of supply chain management and planning experience for a global or multi-plant industrial company<br>
<li>
<br>
<br>
</li></ul></div></div><div><div><h2 class="jobSectionHeader"><b>Skills:
</b></h2></div><div><ul><li>Experience working across supply chain/operations with a proven track record of influencing &amp; delivering results across the end-to-end product and supply chain management processes
</li><li>Experience as a leader of people
</li><li>Ability to manage complex material flows across multi-tier manufacturing &amp; distribution networks
</li><li>Prior experience of Advanced Planning Systems would be a plus
</li><li>Broad foundational technical expertise across areas such as planning, execution, procurement &amp; plant operations
</li><li>Experiencing building strong partnerships and influencing cross functional stakeholders in sales, finance, product line leaders and HR
</li><li>Deep understanding of how supply chain impacts P&amp;L and working capital
</li><li>Ability to analyze, interpret and draw conclusions on large volumes of data
</li><li>CPIM certification would be a plus
</li><li>Holistic perspective, ability to adapt to different cultures and to get results in a complex environment
</li><li>Influential, visible internal and external leader able to challenge the status quo, motivate and inspire teams to work together to solve complex challenges
</li><li>Must be able to build strong relationships at all levels
</li><li>Storytelling ability using data to generate scenarios, including communicating outcomes to a non-technical audience
</li></ul></div></div><div><div><h2 class="jobSectionHeader"><b>What We Offer:
</b></h2></div><div><ul><li>Competitive compensation and benefits package
</li><li>Flexible working solutions
</li><li>Excellent working environment &ndash; safety and ethics are important for us
</li><li>Culture &amp; Values &ndash; we are more than the products we invent and produce &ndash; the way we do business is just as important. At Eaton, our values and culture define who we are &ndash; both individually and as an organization &ndash; and direct our activities every day
</li><li>Learning &amp; Development - we invest in our employees for the long term &ndash; not just with salary and benefits, but with ongoing learning and development opportunities, made available through Eaton University
</li></ul></div></div></div><p>All positions may require participation in video and in-person interviews as part of the hiring process. All candidates will be evaluated based on job-related competencies, and all candidates&rsquo; privacy rights and data security will be protected in accordance with applicable laws.<br>
</p><p></p><p>We are committed to ensuring equal employment opportunities for job applicants and employees. Our recruitment processes use balanced selection criteria and avoid unlawful discrimination against applicants on the basis of their age, colour, disability, marital status, national origin, gender, gender identity, genetic information, race or racial origin, religion, sexual orientation or any other status protected or required by law.</p></div>

Network Planning Manager - Supply Chain Planning & Execution

Traffic Control Signal Technology (Beijing) Co., Ltd.

<div>
 <p>
  <strong>
   Job Title: Project Assistant
  </strong>
 </p>
 <p>
  <strong>
   Responsibilities:
  </strong>
 </p>
 <ol>
  <li>
   Assist the project manager in various support tasks during project execution to ensure the project proceeds as planned.
  </li>
  <li>
   Organize and archive project-related documents and materials, ensuring accuracy and timeliness of information transfer.
  </li>
  <li>
   Coordinate internal and external communications, participate in project meetings, and complete meeting minutes and follow-up tasks.
  </li>
  <li>
   Track project progress, costs, and resource utilization, and submit regular project status reports.
  </li>
  <li>
   Support daily office management at overseas project sites to ensure smooth cross-cultural communication.
  </li>
 </ol>
 <p>
  <strong>
   Requirements:
  </strong>
 </p>
 <ol>
  <li>
   Proficient in Turkish (listening, speaking, reading, and writing) for business communication.
  </li>
  <li>
   Strong organizational and coordination skills with the ability to handle multiple tasks efficiently.
  </li>
  <li>
   Detail-oriented and responsible, with a strong sense of accountability and execution.
  </li>
  <li>
   Able to work on overseas assignments, with good stress tolerance and adaptability.
  </li>
  <li>
   Skilled in using office software, with basic document processing and data analysis capabilities.
  </li>
 </ol>
</div>


Project Assistant

Precision for Medicine

<div><p>Precision for Medicine is a Clinical Research Organization. Precision's uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas.</p>
<p>
As our company continues we grow we are seeking a Principal Regulatory and Start Up Specialist to join our growing team.</p>
<p>
Essential functions of the job include but are not limited to:</p>
<div>
Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks.<br>
<ul><li>Responsible for driving country level submissions and site activation processes by coordinating activities when multiple RSSs are assigned within the country.</li><li>Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to CA, EC and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP.</li><li>Interaction with CA/EC for study purposes and handling responses to the CA/EC.</li><li>Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team as relevant.</li><li>Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated.</li><li>Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria.</li><li>Partner with the assigned site CRA to ensure alignment in communication and secure site collaboration.</li><li>Prepare, review and manage collection of essential documents required for site activation/IMP release.</li><li>Customize country/site specific Patient Information Sheet and Informed Consent Forms.</li><li>Responsible for/facilitates the translation and co-ordination of translations for documents required for submission.</li><li>Maintain communication with other key functions participating to country start up i.e., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables.</li><li>Act as SME for collection and maintenance of site level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements and other required reviews to secure on time site activation for the assigned sites in the country.</li><li>When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department.</li><li>Keep an updated knowledge of the local clinical trial laws, regulations and help distributing this knowledge within PfM to ensure the conduct of Clinical Trials according to international</li></ul>
and local/national applicable regulations.<br>
<ul><li>Maintain audit/inspection readiness at all times and file documents as per TMF plan and/ or study specific plans in the relevant TMF</li><li>May support the clinical team performing Pre-Study Site Visits.</li><li>May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study.</li><li>Will support development of country specific Country Start-up summary and process flow identifying timelines, risks, and success factors.</li><li>Will support development of training sessions to expand Country Start-up knowledge and act as Subject Matter Expert for queries.</li><li>Will mentor staff on local country regulations, submissions and internal procedures, as well as on PFM SSU specific guidance and tools.</li><li>Can assume ownership of departmental process improvements / initiatives, including finalization, roll out and periodic reviews.</li><li>May interact with clients to provide activation readiness status updates, request documents or document review, and participate in proposal activities, including slide development and client presentation as required.</li><li>May act up in the role of Start Up Lead to drive site start up activities to meet activation timelines on smaller or single country studies or by acting as a regional Start Up Lead on larger global studies under the direction of the global Start Up Lead.</li><li>May interact with clients during KOMs, including slide development and client presentation,as required.</li></ul></div><div><br>
Qualifications:<br>
Minimum Required:<br>
<ul><li>Bachelors' degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent combination of education, training, and experience.</li><li>5 years or more as a Regulatory or SU specialist in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies.</li></ul></div><div><br>
Other Required:<br>
<ul><li>Excellent communication and organizational skills are essential.</li><li>Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.</li><li>Fluency in English and Turkish.</li><li>Ability to prioritize workload to meet deadlines.</li><li>Experience in driving cross-functional activities, coordination and oversight of a team.</li></ul></div>
<div>
Preferred:<br>
<ul><li>Must have relevant regulatory and site start-up (feasibility, contract negotiations, CA/EC/IRB submissions) experience for the particular country. Experience in country set up would be highly beneficial.</li><li>Must have experience using milestone tracking tools/systems.</li><li>Must be able to assist junior SU specialists in problem resolution.</li><li>Advanced degree in medical or life sciences (MD, PhD, PharmD)/RAC certification/Masters in Regulatory Science Competencies</li><li>Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.</li><li>Ability to follow task-specific procedures, be attentive to detail and place importance on accuracy of information.</li><li>Excellent organizational skills.</li><li>Ability to work independently in a fast-paced environment with a sense of urgency to match the pace.</li><li>Must demonstrate excellent computer skills.</li><li>Excellent communication, presentation, interpersonal skills, both written and spoken,</li></ul>
with an ability to inform, influence, convince, and persuade.<br>
<ul><li>Flexible attitude with respect to work assignments and new learning.</li><li>Occasional travel may be required</li></ul></div>
<p>
#LI-OS1 #LI-Remote</p>
<p>
We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.</p><p></p><div><p><br>
Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.</p>
<p>
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.</p>
<p>
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.</p>
<p>
It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.</p></div></div><p></p>

Regulatory and Start Up Specialist

Precision Medicine Group

<div><p>Precision for Medicine is a Clinical Research Organization. Precision's uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas.</p>
<p>
As our company continues we grow we are seeking a Principal Regulatory and Start Up Specialist to join our growing team.</p>
<p>
Essential functions of the job include but are not limited to:</p>
<div>
Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks.<br>
<ul><li>Responsible for driving country level submissions and site activation processes by coordinating activities when multiple RSSs are assigned within the country.</li><li>Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to CA, EC and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP.</li><li>Interaction with CA/EC for study purposes and handling responses to the CA/EC.</li><li>Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team as relevant.</li><li>Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated.</li><li>Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria.</li><li>Partner with the assigned site CRA to ensure alignment in communication and secure site collaboration.</li><li>Prepare, review and manage collection of essential documents required for site activation/IMP release.</li><li>Customize country/site specific Patient Information Sheet and Informed Consent Forms.</li><li>Responsible for/facilitates the translation and co-ordination of translations for documents required for submission.</li><li>Maintain communication with other key functions participating to country start up i.e., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables.</li><li>Act as SME for collection and maintenance of site level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements and other required reviews to secure on time site activation for the assigned sites in the country.</li><li>When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department.</li><li>Keep an updated knowledge of the local clinical trial laws, regulations and help distributing this knowledge within PfM to ensure the conduct of Clinical Trials according to international</li></ul>
and local/national applicable regulations.<br>
<ul><li>Maintain audit/inspection readiness at all times and file documents as per TMF plan and/ or study specific plans in the relevant TMF</li><li>May support the clinical team performing Pre-Study Site Visits.</li><li>May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study.</li><li>Will support development of country specific Country Start-up summary and process flow identifying timelines, risks, and success factors.</li><li>Will support development of training sessions to expand Country Start-up knowledge and act as Subject Matter Expert for queries.</li><li>Will mentor staff on local country regulations, submissions and internal procedures, as well as on PFM SSU specific guidance and tools.</li><li>Can assume ownership of departmental process improvements / initiatives, including finalization, roll out and periodic reviews.</li><li>May interact with clients to provide activation readiness status updates, request documents or document review, and participate in proposal activities, including slide development and client presentation as required.</li><li>May act up in the role of Start Up Lead to drive site start up activities to meet activation timelines on smaller or single country studies or by acting as a regional Start Up Lead on larger global studies under the direction of the global Start Up Lead.</li><li>May interact with clients during KOMs, including slide development and client presentation,as required.</li></ul></div><div><br>
Qualifications:<br>
Minimum Required:<br>
<ul><li>Bachelors' degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent combination of education, training, and experience.</li><li>5 years or more as a Regulatory or SU specialist in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies.</li></ul></div><div><br>
Other Required:<br>
<ul><li>Excellent communication and organizational skills are essential.</li><li>Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.</li><li>Fluency in English and Turkish.</li><li>Ability to prioritize workload to meet deadlines.</li><li>Experience in driving cross-functional activities, coordination and oversight of a team.</li></ul></div>
<div>
Preferred:<br>
<ul><li>Must have relevant regulatory and site start-up (feasibility, contract negotiations, CA/EC/IRB submissions) experience for the particular country. Experience in country set up would be highly beneficial.</li><li>Must have experience using milestone tracking tools/systems.</li><li>Must be able to assist junior SU specialists in problem resolution.</li><li>Advanced degree in medical or life sciences (MD, PhD, PharmD)/RAC certification/Masters in Regulatory Science Competencies</li><li>Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.</li><li>Ability to follow task-specific procedures, be attentive to detail and place importance on accuracy of information.</li><li>Excellent organizational skills.</li><li>Ability to work independently in a fast-paced environment with a sense of urgency to match the pace.</li><li>Must demonstrate excellent computer skills.</li><li>Excellent communication, presentation, interpersonal skills, both written and spoken,</li></ul>
with an ability to inform, influence, convince, and persuade.<br>
<ul><li>Flexible attitude with respect to work assignments and new learning.</li><li>Occasional travel may be required</li></ul></div>
<p>
#LI-OS1 #LI-Remote</p>
<p>
We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.</p><p></p><div><p><br>
Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.</p>
<p>
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.</p>
<p>
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.</p>
<p>
It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.</p></div></div>

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