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Job Description
Vertex seeks a dynamic and experienced Medical Affairs physician executive to lead the new Disease Area of Nephrology within the Global Medical Strategy group. This individual will be responsible for the development of Global Medical strategy across the current APOL1-MEDIATED KIDNEY DISEASE (AMKD) and for the development of the life cycle management plan. The individual will partner with the International and North America regions to drive globally aligned medical brand and evidence generation plans which reflect country and regional insights and needs. This individual must work effectively with his/her cross-functional counterparts in Development, Research, and Commercial, and will sit on the Renal Disease Strategy Team to define and implement an encompassing strategy to support enrollment in clinical trials, build the key expert’s network and translate clinical practice into actionable strategies for the potential introduction of a new therapy for a little-known medical condition that requires genetic testing.
Key Responsibilities:
The Executive Director, AMKD Global Strategy will have global responsibility to build the Global Medical strategy for this asset.
Communicate the Global Medical strategy to partner functions for further strategic and tactical guidance.
Build the right relationships with experts in the field for the understanding of the clinical landscape.
Execute the Global components of the medical strategy plan.
Partner with Clinical Development, HEOR, RWE, Regional Medical Affairs and partner functions to identify evidence gaps and coordinate evidence generation to generate data in support of global product initiatives.
Ensure all Medical Affairs initiatives are aligned with overall brand plans and in compliance with corporate polices and regulatory requirements.
Determine staffing requirements for the group and successfully recruit, develop and retain an effective team. The successful candidate will evaluate and update process and operating procedures for this group that are consistent with general guidance already in place for the organization.
Minimum Qualifications:
The successful candidate will have a medical degree or PhD from a well-regarded institution and at least 7 years of experience in industry, with at least 3 of those in an industry managerial role leading clinical and/or medical programs. The ideal candidate will have nephrology training and clinical practice experience.
In addition to deep technical competence, she/he will exhibit sound business judgment with an understanding of the significant financial investments and the ultimate impact that the role has on product opportunities and on the Company.
The Executive Director, AMKD Global Strategy will be a natural leader, possessing the skills to build, lead, develop and work with teams and individuals in a global, functionally matrixed environment.
The successful candidate will possess excellent communication and relationship skills. S/he will communicate with a style that is clear, complete and concise. S/he will have well-established networks and be able to develop and maintain strong professional relationships internally and externally by gaining credibility and confidence with others.
S/he will exhibit a high level of directed energy toward developing and achieving objectives that will inspire others.
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.
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Job Description
Vertex seeks a dynamic and experienced Medical Affairs physician executive to lead the new Disease Area of Hematology within the Global Medical Strategy group. This individual will be responsible for the development of Global Medical strategies for the first FDA approved CRISPR-cas9 medicine (Exa-Cel) for the treatment of Sickle Cell Disease and Infusion dependent B-Thalassemia, including the development of the life cycle management plan. The successful candidate will be an experienced people manager who is passionate about developing talent to whom the HEME Global Medical team will report to. The individual will partner with the International and North America regions to drive globally aligned medical brand and evidence generation plans which reflect country and regional insights and needs. This individual must work effectively with his/her cross-functional counterparts in Development, Research, and Commercial, and will sit on the HEME Disease Strategy Team to define and implement the medical affairs strategy for Exa-Cel.
Key Responsibilities:
The Executive Director, HEME Global Strategy will have global responsibility to build the Global Medical strategy for Exa-Cel.
Communicate the Global Medical strategy to partner functions for further strategic and tactical guidance.
Execute the Global components of the medical strategy plan.
Partner with Clinical Development, HEOR, RWE, Regional Medical Affairs and partner functions to identify evidence gaps and coordinate evidence generation to generate data in support of global product initiatives.
Ensure all Medical Affairs initiatives are aligned with overall brand plans and in compliance with corporate polices and regulatory requirements.
Determine staffing requirements for the group and successfully recruit, develop and retain an effective team. The successful candidate will evaluate and update process and operating procedures for this group that are consistent with general guidance already in place for the organization.
Minimum Qualifications:
The successful candidate will have a medical degree or PhD from a well-regarded institution and at least 7 years of experience in industry, with at least 3 of those in an industry managerial role leading clinical and/or medical programs. The ideal candidate will have sub-specialty training in Hematology / Transplant medicine.
In addition to deep technical competence, she/he will exhibit sound business judgment with an understanding of the significant financial investments and the ultimate impact that the role has on product opportunities and on the Company.
The Executive Director, HEME Global Strategy will be a natural leader, possessing the skills to build, lead, develop and work with teams and individuals in a global, functionally matrixed environment.
The successful candidate will possess excellent communication and relationship skills. S/he will communicate with a style that is clear, complete and concise. S/he will have well-established networks and be able to develop and maintain strong professional relationships internally and externally by gaining credibility and confidence with others.
S/he will exhibit a high level of directed energy toward developing and achieving objectives that will inspire others.
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.
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Current Saint Francis Employees - Please click HERE to login and apply.
Job Summary: The VP, Associate Chief Medical Officer/Executive Clinician develops and oversees the management of medical processes for Saint Francis Health System (SFHS), ensuring coordination of healthcare services and standards within the organization. This role will also provide patient care including assessment, diagnoses, and administration of comprehensive treatment.
Minimum Education: Commensurate education as appropriate to obtain Oklahoma State medical license and to be board certified or board eligible in the chosen specialty at the time of hire.
Licensure, Registration and/or Certification: Valid Oklahoma State Medical License.
Work Experience: Minimum 5 years of progressively responsible executive leadership experience in hospital setting or large health care organization.
Knowledge, Skills and Abilities: Working knowledge of Microsoft Office Suite. Demonstrated excellent verbal and written communication and interpersonal skills. Ability to analyze information and provide well-founded recommendations, demonstrating strong critical thinking skills. Ability to facilitate effective communications across all organizational levels.
Essential Functions and Responsibilities:
Administrative/Executive Responsibilities - Establishes short and long-term strategies that ensure excellent operational performance, drive clinical practice growth and support the mission of SFHS. Leads clinical performance expectations that support the goals of consistent clinical performance and provider practice across the facility resulting in superior clinical outcomes and unparalleled patient experience. Creates an environment of quality and cost improvement that is data driven and develops systems to review utilization of resources and objectively measure outcomes of care in the inpatient and outpatient settings. Serves as a direct liaison between physicians, medical staff, and health system leadership. Assembles facility physician advisory panels (as needed) to provide ongoing feedback to SFHS senior leadership. Develops and executes clinical improvement strategies, including efforts for improved patient outcomes, reduced care variation, reduced physician/medical staff burnout, and enhanced physician/medical staff engagement.
Clinical Responsibilities - Provides patient care services for which he/she is clinically privileged. Provides direct patient care services on an inpatient and outpatient basis including subspeciality consultations, follow ups, and diagnostic and therapeutic services/procedures. Recommends, participates in, and works to ensure the success of efforts to improve cost effectiveness and quality of care provided to patients. Participates in academic programs (e.g. medical education and research) as requested. Provides effective interdisciplinary team participation and support through collaboration with healthcare providers and referral sources, communication with patients and appropriate family members.
Decision Making: Independent judgement in making decisions from many diversified alternatives that are subject to general review in the final stages only.
Working Relationships: Direct supervision of others. Prepares and gives performance evaluations. Works with internal and/or external customers via telephone or face to face interaction. Works with other healthcare professionals and staff.
Special Job Dimensions: None.
Supplemental Information: This document generally describes the essential functions of the job and the physical demands required to perform the job. This compilation of essential functions and physical demands is not all inclusive nor does it prohibit the assignment of additional duties.
Administration Offices (Payroll Use) - Yale CampusLocation:
Muskogee, Oklahoma 74401EOE Protected Veterans/Disability
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The Role:
Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives. Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience with the potential to make a significant impact on patients' lives worldwide.
Moderna is enhancing its global footprint in Singapore, a key player in the global biotech industry. Our Singapore office will focus on commercial operations, bringing our pioneering mRNA treatments to the Singaporean market. We're in search of passionate professionals dedicated to transforming global health through our innovative mRNA technology.
We are seeking an Executive Director of Medical Affairs to lead our medical initiatives in Singapore and provide overarching strategic guidance for the entire Asia-Pacific emerging markets. This pivotal role requires a visionary leader with the acumen to oversee Medical Affairs activities in Singapore and shape the region's medical landscape in alignment with Moderna’s global healthcare ambitions.
Here's What You'll Do:
Your key responsibilities will be:
Define and champion the Medical Affairs plan for infectious diseases across Asia-Pacific emerging markets, with a focus on COVID-19 and future vaccination initiatives.
Build and lead medical teams, fostering a culture of scientific excellence and integrity.
Engage with healthcare authorities, payers, and scientific communities to advance medical research and strategies.
Orchestrate regional insight and scientific leadership activities to support clinical development and innovative vaccination approaches.
Your responsibilities will also include:
Strategically steer Singapore's Medical Affairs strategy and operations.
Develop and maintain strategic relationships with local healthcare practitioners, regulatory authorities, and health institutions.
Lead medical affairs contributions to reimbursement submissions, procurement agreements, and tenders in Singapore.
Serve as Moderna’s representative within Singapore, enhancing our profile and influence through industry associations, media interactions, and external engagements.
The key Moderna Mindsets you’ll need to succeed in the role:
We pursue options in parallel: This role requires the ability to handle multiple initiatives and make the best choices for the region's healthcare landscape.
We question convention: You'll need to challenge existing models and approaches to shape innovative strategies that align with Moderna’s ambitions.
Here’s What You’ll Need
M.D. or equivalent degree from a recognized Medical School (advanced degree and a current license to practice are a plus).
Minimum 15 years of experience in the global pharmaceutical industry in Clinical Development and/or Medical Affairs with a demonstrated successful track record.
Experience in vaccine clinical development and medical affairs.
Proven leadership skills, including the ability to train and develop talent and create a high-performing team.
Strong prioritization, decision-making, and organizational skills.
Proven expertise in engaging with scientific leaders and other key stakeholders, preferably in the field of Vaccines.
Excellent oral and written communication skills.
Ability to lead and collaborate in cross-functional teams in a matrix environment.
Knowledge of clinical trial methodology, regulatory requirements, and the compliance environment.
Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.
We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:
The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.
About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!
Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)
#LI-AG2-
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Job Description
The Executive Medical Director, Patient Safety/Head Medical Safety and Risk Management will oversee all safety and benefit-risk related activities of the GPS Physician (Disease-area Safety Heads, DST Chairs) and the Aggregate Report Risk Management (ARRM) Groups within the Vertex Global Patient Safety (GPS) Department. As a member of the GPS Senior Leadership Team, the role will contribute to ensuring consistency and compliance in the safety assessment, analysis and reporting for all designated product(s) throughout Vertex’s world markets. Overseeing the GPS DASH/DST teams across therapeutic areas, the role will ensure consistent conduct and timely execution of Benefit-Risk activities by GPS DASH/DST teams, including pre-marketing risk assessment, planning for First-In-Human (FIH) studies, safety content of key Modules (SCS, CLO, Labelling) in regulatory authority submissions for approval, including planning, content and execution of Risk Management Plans (RMPs) and/or Risk Evaluation and Mitigation Strategies (REMS) for and post-marketing requirements. The role will work closely with leaders from cross-functional teams on the successful achievement of key strategic activities, initiatives and deliverables.
Key Duties and Responsibilities:
Provides leadership and oversight of DASH/Disease-area Safety Team(s) (DST) conduct, for all products across the Vertex Portfolio, including pre-FIH activities, key benefit-risk assessment, and providing strategy for DSTs to meet goals and objectives.
Coordinates and oversees the consistent and timely review of safety data for identification of new safety signals, in accordance with Vertex signal detection practices.
Collaborates with Clinical Leaders to develop and implement appropriate Risk Management procedures/plans for each product, both pre-approval and post-approval, as needed.
Collaborates with NDA teams assessment, strategy and execution of key Regulatory Authority documents in support of submissions, specifically leading safety content of key Modules (SCS, CLO, Labelling) and development of any Risk Evaluation and Mitigation Strategy (REMS), Risk Management Plan (RMP) or equivalent documents.
Collaborates with GPS Epidemiology with regards to development, implementation and reporting of pharmacoepidemiology studies, as needed.
Reviews and/or assists in preparation of Developmental and/or Post-Marketing Periodic Safety Updates (DSURs, PSURs/PBRERs), IND packages, as well as NDA and INDs.
Provides review and safety-specific input for labeling documents, including IB, CCDS, USPI, SmPC and other local labels, as applicable.
Collaborates with Regulatory Affairs to develop responses to any safety related regulatory agency inquiries.
Provides and oversees medical review of aggregate and/or individual post-marketing and clinical trial adverse event reports, in accordance with GPS review practices.
Oversees medical evaluation of other relevant non-AE/SAE related safety information, such as from Toxicology, Non-Clinical studies and Product Quality sources.
Reviews and provides oversight for medical content for key study-related documents, e.g., Protocols, Statistical Analysis Plan, IB, ICF and IDMC Charter.
Reviews and provides oversight in the analysis of safety data from on-going and completed clinical trials and representation in Clinical Study Reports.
Reviews and provides oversight of safety sections of clinical study reports.
Provides a contributory role in Partner /Affiliate agreements and interactions, as needed.
Serves as Subject Matter Expert in departmental development activities including SOP and Work Instructions development.
Leads Medical staff and liaise with Operations leads regarding optimal practice regarding collection, evaluation and processing of adverse experience reports, from a medical perspective.
Leads and guides direct reports, regarding the scope of DASH/DST Chair Physician responsibilities, and the provision of sound medical input for all pre-marketing and post-marketing activities.
Facilitates the growth and development of staff and direct reports.
Knowledge and Skills:
Extensive knowledge of GCP, ICH and Global regulations.
In-depth and comprehensive knowledge of General Medicine.
Strong leadership skills with the ability to communicate effectively in a matrix environment.
Experience in the critical evaluation and interpretation of data, with ability to synthesize into clear, coherent messaging.
Extensive knowledge of Benefit-Risk strategies and decision-making.
Ability to multi-task, adeptly handling multiple demands.
Education and Experience:
MD, DO or equivalent ex-US medical degree
12+ years of work experience with experience in Pharmacovigilance and 7 years of supervisory/management experience, or the equivalent combination of education and experience
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.
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Job Type:
RegularEqual Employment Opportunity Statement
Roswell Park Cancer Institute Corporation (RPCIC) and Health Research Inc. (HRI) Roswell Park Division believe that all persons are entitled to equal employment opportunities, and we do not discriminate against our employees, applicants or job seekers because of their race, color, religion, sex, sexual orientation, gender identity or expression, national origin, creed, age, disability, pregnancy-related condition, military or veteran status, marital or familial status, domestic violence victim status, citizenship status, genetic information, individual’s relationship or association with a member of a protected category or any other protected group status as defined by law.
Reasonable Accommodation Request
RPCIC and HRI are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email HR-PayAndBenefits@RoswellPark.org and let us know the nature of your request and your contact information.
Our Core Values
RPCIC and HRI are committed to providing an environment where patients, families, employees and community are treated with courtesy and respect. We support an inclusive environment that nurtures the talents, skills and abilities of each individual to embody and reflect our core values: Innovation, Integrity, Teamwork, Commitment, Compassion and Respect.
Historical Compensation Information Statement
Pursuant to Executive Order 161, no State entity, as defined by the Executive Order, is permitted to ask, or mandate, in any form, that an applicant for employment provide his or her current compensation, or any prior compensation history, until such time as the applicant is extended a conditional offer of employment with compensation. If such information has been requested from you before such time, please contact the Governor’s Office of Employee Relations at (518) 474-6988 or via email at info@goer.ny.gov.
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Education:
Master’s Degree in Health Services Administration, and/or Nursing, or Related Field Required
Bachelor’s Degree in Health Services, or Human Services or Related Field Required
Experience:
Seven years Healthcare – Oncology Cancer Care Required
Three to five years Healthcare Management – Required
Program Development Required
Skills:
Knowledge and understanding of the trends and forces that shape the health care delivery system, the provision of care, and other emerging issues in health care.
Demonstrates flexibility and initiative to effectively lead change efforts to respond to environmental or organizational change.
Working with Physicians, building strong and trusting relationships with physician and physician leadership required
Working knowledge of oncology practice operations; including, physician practice operations and the components and requirements requisite for successful patient care, quality, and efficiencies, including the demonstrated ability to design and integrate workflows acceptable to providers and staff.
Proven personnel management strength including demonstrated ability to select, motivate, develop and retain people andpromote collaborative team efforts.
Proven experience in leading quality and service improvement activities and achieving outcomes, which respond to customer expectations.
Experience in effectively leading the design and organization of work, and allocation of resources to achieve appropriate staffing levels and mix, and productivity levels.
Expertise in data gathering, management, reporting and interpretation.
Proficient in Microsoft Office Products (Word, Excel, Outlook and Power Point).
Must have excellent interpersonal, written, verbal communication and public speaking skills.
Evenings and weekend work may be required.
Travel to a variety of service locations will be required.
A high degree of organizational skills, ability to set priorities, manage multiple demands and the ability to complete tasks under strict timelines is required.
Knowledge of using practice management information systems to enhance the delivery of care, productivity, and efficient business operations.
Manage multi-specialty practice departments.
Thorough understanding of EMRs and how they relate to practice management.
Pay Range:
$216,268.00 - $324,402.00SalaryOfficial account of Jobstore.
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Major duties include but not limited to:
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The Deputy Executive Director, Medical Center's managerial duties and responsibilities involve final decisions which have a direct and substantial effect on the health care organization and programs. These include, but are not limited to, decisions affecting the nature, scope and quality of, and emphases in the facility's/system's patient care programs and activities.
The Deputy Executive Director, Medical Center in collaboration with the Executive Director, Medical Center:
* Determines program goals and objectives, and develops short and long-range plans for achieving them, in conjunction with the overall plans of the Veterans Integrated Service Network (VISN) consistent with the strategic planning process;
* Directs a comprehensive evaluation of program goals and objectives and makes necessary adjustments to improve delivery of patient care services;
* Establishes local policy in such areas as program emphases and operating guidelines;
* Administers a system for the development and communication of program policies and procedures in accordance with new or existing rules and regulations, and ensures adherence to them; and
* Administers a management reporting system which provides appropriate data for decision making in such areas as: organizational improvements; changes in delegations of authority; position management; and coordination among the center's programs and services.
The Deputy Executive Director, Medical Center will :
* Organize and control program evaluation activities;
* Develop and coordinate a quality assurance program to ensure that both clinical and administrative activities are in compliance with standards issued by various accrediting and regulatory groups;
* Develop plans (with target completion dates) to ensure that action has been taken to correct deficiencies cited by accrediting bodies
*Conduct a comprehensive and effective quality management program for the standpoint of quality or program/service management, and
* Ensure that patient complaints related to the communication of clinical aspects of their care are promptly addressed.
The Deputy Executive Director, Medical Center:
*Develops with the participation of administrative and clinical managers and chiefs, plans for fiscal year plans that meet the objectives of current and proposed programs;
* Develops a balanced financial plan designed to meet realistic needs of the facility and the network; makes important decisions substantially affecting economy of operations by limiting operating expenses without impairing patient care activities through management assessment, cost effective position management techniques, reorganization, methods improvements, and automation;
* Ensures that utilization of available resources is in line with plan or modified through recurring review;
* Allocates available resources to provide the best possible patient care in line with established priorities;
* Expects and obtains, as the accountable official, positive accomplishments in effective utilization of resources as relaxed to budget, manpower, equipment, contractual services, physical facility needs and FTEE control;
* Protects integrity of the budget, position management, classification and other processes to ensure compliance with existing statutes, and regulations; and takes timely corrective action where delegated responsibilities are not being properly applied or executed.
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