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Payment Thresholds and DQIM Implementation Support #168218

Credit Suisse AG

Zürich, ZH
Vor 1 Tag
Zürich, ZH
Vor 1 Tag
Payment Thresholds and DQIM Implementation Support #168218
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Senior Technical Expert / Technology Manager (m/f)

Weidmann Electrical Technology AG

Rapperswil, SG
Vor 3 Tagen
Rapperswil, SG
Vor 3 Tagen

Weidmann Electrical Technology, a business area of the Weidmann Group, is the world's leading developer and manufacturer of specialized products and services for transformers and cellulose-based, sustainable industrial materials. The Weidmann Group, headquartered in Rapperswil-Jona, Switzerland, is active worldwide in more than 30 locations and employs a staff of 2’800.

Weidmann Electrical Technology AG based in Rapperswil SG is looking to recruit a


Senior Technical Expert / Technology Manager (m/f)

Your tasks: Technical consulting (internal, external, to OEM customers as well as utilities etc.) • Management and participation in technology and R&D projects • Development of internal expertise in transformers (design, production, operation) / transformer insulation
• Representation of Weidmann in technical expert committees (IEC, IEEE, CIGRE etc.) and at industry conferences • Management of technical resources

Your qualifications: Design of power transformers / transformer insulation systems • Strong communication and presentation skills, covering technical topics • Project management • Strong interpersonal skills and effective team management • Ability to work in a multicultural environment (internal and external) • Significant experience in the management of technical groups • Fluent in English (company language), German of significant benefit, other languages beneficial • Willingness for business trips abroad (20 – 30% of time) • Legal right to work in Switzerland or the EU region

We are looking forward to receiving your complete application

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Payment Thresholds and DQIM Implementation Support #168218

Credit Suisse AG

Zürich, ZH
Vor 1 Tag
Zürich, ZH
Vor 1 Tag
Payment Thresholds and DQIM Implementation Support #168218
Jetzt bewerben
Apply Now
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MQ Administrator/Engineer and Lead #161413

Credit Suisse AG

Zürich, ZH
Vor 3 Tagen
Zürich, ZH
Vor 3 Tagen
MQ Administrator/Engineer and Lead #161413
Jetzt bewerben
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PEGA Software Developer/3rd Level Support - Product Processing/CasePro, Staff-AVP, Location Bern-...

Credit Suisse AG

Guemligen, BE
Vor 6 Tagen
Guemligen, BE
Vor 6 Tagen
PEGA Software Developer/3rd Level Support - Product Processing/CasePro, Staff-AVP, Location Bern-Gümligen #167411
Jetzt bewerben
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Manager Country Safety Lead

Randstad Schweiz AG

Luterbach, SO
Vor 24 Tagen
Luterbach, SO
Vor 24 Tagen

Randstad Professionals is looking for a Manager Country Safety Lead for a major client based in Solothurn.

Contract period: 6 months

Start date: ASAP

The Country Safety Head (CSH) is the primary Pharmacovigilance (PV) point of contact for the local territory. The CSH is responsible for the end-to-end operation, management and oversight of local PV tasks in compliance with all applicable local regulations, guidance and global business requirements. The CSH is a key strategic partner for the local business and provides valued consultation and collaboration to all affiliate stakeholders and functions to support local objectives. The CSH also contributes to the Global and Regional PV strategy as required.

Your responsibilities:

  • Accountable for establishing and maintaining a local PV structure and related practices in compliance with local Regulation and in synergy with the clients Global PV system.

  • Responsible for the identification of outsourcing needs and the recruitment, onboarding, training, oversight and general end-to-end set-up of PV Operations Vendors and Service Providers; ensures alignment with applicable global oversight strategies for vendors, i.e. safety report reconciliation, vendor quality monitoring, monthly report etc.

  • Ensures appropriate storage and archiving of safety reports and training records

  • Authors local documents, such as Standard Operating Procedures (SOPs), Guidelines, Safety Management Plans/Manuals, Vendor Service Agreements, and ensures content alignment with GSRS procedures and Local PV requirements; ensures regular updates of these documents as per the established review cycles and as required according to enhancement needs.

  • Leads and collaborates with local Finance and Global Management on budget and resource planning for local PV activities.

  • Maintains a constant state of inspection readiness by maintaining appropriate documentation/evidence that demonstrates the efficient and compliant functioning of the local PV structure.

  • As required, contributes to projects related to any technical updates to PV practices (e.g. electronic submission of ICSRs to HAs).

  • Manages other local safety staff and resources as is applicable.

  • Contributes to and/or leads additional Local, Regional or Global strategic priorities, projects and responsibilities as required.

  • ICSR Management: Responsible for establishing optimum and harmonized processes for the receipt, collection and submission (as applicable) of Individual Case Safety Reports (ICSRs) for Company products from any source. Ensures procedures related to Literature Screening and ICSR Follow-up are in place.

  • Ensures ICSR submission is performed according to local requirements and tracks local regulatory submission of ICSRs and aggregate safety reports as necessary, in collaboration with medical reviewers.

  • Maintains close working connections with all local teams and functions; the primary point of contact to be consulted for all matters that impact PV within the affiliate; a standing member of relevant affiliate governance structures (as needed) to be kept up to date on local plans and projects that may have an impact on PV; provide strategic and operational recommendations to affiliate teams and projects to facilitate compliance with PV requirements.

  • Contributes to the global strategy for PV oversight and compliance management; implements effective measures to monitor compliance and quality of key local PV procedures and operations (including but not limited to ICSR collection and Health Authority (HA) submissions, as applicable) in the post-

  • marketing space in collaboration with International PV (IPV); incorporates the use of empirical data (both quantitative and qualitative) to drive continuous improvement of the local PV system.

  • Maintains awareness of all Organized Data Collection Programs (ODCPs) (such as Patient Support Programs (PSPs) and Market Research Programs (MRPs)), Extended Access Programs (EAPs), Compassionate Use (CU), Registries, Digital and Social Media Activities that are relevant to the local territory; ensures appropriate PV Processes are in place (e.g. Adverse Event Collection); ensures adherence with the Global PV Governance structure and procedures.

  • Serve as PV contact person in- and externally for local staff, GSRS and health authority

  • Responsible for the fulfillment of LQPPV Responsibilities as per local regulation; The LQPPV ensures there is comprehensive understanding of these specific responsibilities at the Local, Regional and Global level, in order to enable compliance with regulatory expectations for the role.

  • Acts as the local expert in all matters pertaining to PV within the post-marketing space and the aligned territory and provides strategic and operational consult to the local business. Contributes to PV matters in the Clinical space as required in collaboration with other GSRS functions. Contributes to the GSRS PV Regulatory Intelligence infrastructure by maintaining a detailed understanding and continuous awareness of the local PV Regulation / Guidance and any updates or changes; actively participates in relevant local trade associations, working groups and creates appropriate connections with local Health Authorities and influential institutions within the PV space.

  • Notify EU QPPV/GSRS of changes in local PV legislation/guidance, changes in PV personnel, and interactions with local Competent Authorities regarding safety issues.

  • Participates in any public consultations on planned changes to PV Regulation in close collaboration with International PV (IPV). Anticipate changes in PV Regulations and plans for changes in local procedure and templates accordingly.

  • Authors and maintains PV-related training and ensures regular delivery to all Affiliate staff, PV Operations Vendors and Service Providers including but not limited to training pertaining to AE collection responsibilities.

  • Assists GSRS with regulatory agency inquiries, CAPA investigation and implementation

  • Acts as the primary contact and Subject Matter Expert (SME) for local Audits and as required for local HA Inspections (including the interviewee role and collating responses to document requests); plays a lead role in the facilitation and coordination of local audits and inspections in collaboration with the applicable Quality teams; ensures there is timely and appropriate communication throughout the life-cycle of the Audit or Inspection to key Local and Global stakeholders including International PV (IPV); contributes as required to the Global Auditing strategy as it relates to the local territory.

  • The CSH is responsible for appropriate communication with local Health Authorities in partnership with other local functions (e.g. Regulatory Affairs and Medical Affairs); collaborates with regulatory colleagues to ensure safety notifications and submission of safety documents are performed in a compliant manner; coordinates with GSRS management to address safety related requests from the local HA.

If you are interested to take on these responsibilities you should have the following requirements:

  • Minimum of bachelor’s level degree in nursing, pharmacy, or other health care related profession or life sciences required.

  • 3-5 years in drug safety/pharmacovigilance in pharmaceutical industry setting or the equivalent for Manager Level above.

  • Proficiency in English and German

  • In-depth knowledge of Global, Regional and local PV regulations and requirements.

  • Excellent written and verbal communication skills including.

  • Well-developed technical writing skills with the ability to produce clear, concise documentation and communications. Good presentation and analytical skills.

  • Excellent Project Management skills.

  • Good proficiency with common software such as Microsoft Word, Excel, PowerPoint, Outlook.

  • Must work effectively/collaboratively in a fast-paced and matrixed environment.

  • Individual has effective managerial skills (as applicable to job roles and scope), is a self-starter, ability to adapt - to work independently or as part of a team, goal oriented, attention to detail and accuracy, and ability to multitask and prioritize.

  • Strong decision-making skills required.

  • Must demonstrate initiative to effectively identify and communicate issues.

  • Individuals should be able to demonstrate innovative thinking.

  • Knowledge of Good PV Practices

  • Direct experience in GxP compliant quality systems preferred

  • Experience with interacting with third parties (e.g PV operations vendors) required

  • Experience with Adverse Events Intake systems

  • Experience in writing procedures, training materials and effectively delivering training to a diverse audience

  • Experience (e.g. interviewee, control room, document request) of Audits and Regulatory Inspections preferred.

We can offer you a new challenge in a diverse, innovative and multicultural environment. Have we sparked your interest? Then we look forward to receiving your online application.


Please note a Swiss Work permit or EU-citizenship is mandatory for this position.
Reference:15379
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Clinical trial Physician

Randstad Schweiz AG

Allschwil, BL
Vor 19 Tagen
Allschwil, BL
Vor 19 Tagen

Randstad Professionals is currently looking for a Clinical Trial Physician /Medical Doctor (Neuroscience) for a main client located in the surroundings of Basel.

This contracting position is a great opportunity to join a very successful global Pharmaceutical player. The company is in full development with major focus on US and EMEA. The position of clinical Trial Physician is open for immediate requisition. The initial contract will last until december 2020.

REQUIRED QUALIFICATIONS AND EXPERIENCE

• MEDICAL DOCTOR

• At least 4 year- experience in clinical research in a Pharmaceutical or Biotech company or equivalent in Academia

• Clinical research or Clinical experience in the indication relevant to the Clinical Project is preferred (multiple sclerosis)

• Good knowledge of drug development and clinical trial process based on previous experience

• Good knowledge of regulatory requirements/ICH guidelines

• Good organizational skills, able to work as part of a team and independently

• Good communication skills

• Detailed oriented

• Fluent in English

RESPONSIBILITIES AND TASKS

All tasks below should be performed in compliance with GCP and company’s SOP’s.

The CTP is a member of the Clinical Trial Team (CTT). The tasks and activities of the CTP are carried out in close collaboration with the Clinical Trial Scientist (CTS) for the trial related activities and with the Clinical Project Physician (CPP) and Clinical Project Scientist (CPS) for the project related activities.

Key Responsibilities:

• Developing a sound understanding of the science and medicine relating to Neuroscience

• Developing a sound understanding of the complexity of global clinical development with a particular attention to methodological and ethical aspects of development (Neuroscience)

• Performing literature reviews, and write position papers as necessary.

• Contribute to writing of Protocol and Core Informed Consent Form (CICF), including amendments

• Input into the Clinical Study Report (CSR).

• Medical training of the Clinical Trial Team (CTT) members and/or Actelion staff .

• Medical oversight of the study (including safety, quality and performance of the trial).

• Clinical Trial results interpretation.

• Involved in the organization and management of external activities (Contacts with external Experts, Steering Committees (SC), Independent Data Monitoring Committees (IDMC)).

• Answering to trial-related EC/IRB and HA questions.

• Ensuring that the Case Report Form is designed to allow careful and comprehensive collection of data

If you are interested to learn more about this great opportunity, don’t hesitate to get in touch with me. Feel free to send me your CV at following email

olivier.worch@randstad.ch

I am looking forward to receiving your applications

Olivier Worch


Reference:14558
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Scientist - P4

cinfo

Geneva
Vor 8 Tagen
Geneva
Vor 8 Tagen

OBJECTIVES OF THE PROGRAMME

 

The Regulation of Medicines and other Health Technologies unit (RHT) works with Member States and partners to improve the access to essential medicines and other health technologies of assured quality, safety and efficacy or effectiveness. RHT works within the Access to Medicines, Vaccines and Pharmaceuticals (MVP) cluster departments in the wider framework of Universal Health Coverage and category 4 of the General programme of Work, and cooperates with disease oriented programmes (among others HIV/AIDS, TB, malaria, reproductive health, maternal and child health, immunization, NCDs and mental health) towards the Sustainable Development Goals. The department works with a wide range of UN organizations, international partners and expert networks, and WHO Collaborating Centres.

 

DESCRIPTION OF DUTIES

 

Under the responsibility of the Group Lead, Country Regulatory Strengthening (CRS), Regulatory Systems Strengthening (RSS) Team:

  • In the context ofstrengthening of national regulatory systemsconducts benchmarking missions to document the status of regulatory systems for medical products using the harmonized global benchmarking model, according to defined priorities.
  • Provides technically sound assistance in the formulation of institutional development plans, including appropriate capacity building and technical support activities to address identified gaps following the benchmarking, including technical seminars, workshops and or country/regional training courses.
  • Plays a crucial role in the development and continual improvement of the WHO benchmarking tool, policy and procedures including with respect to maturity level, reliance, reassessment, transparency and prioritization.
  • Provides input to the development, improvement and maintenance of IT tools related to regulatory system strengthening activities, including the electronic benchmarking tool, databases and mobile applications.
  • Provides technical advice on regulatory system strengthening activities and relevant regulatory matters, including the development of briefing notes, responses to questions and requests from Regional and Country Offices.
  • Participates in advocacy and contributes to fundraising for the WHO regulatory strengthening program involving multilateral and bilateral donors, including under Pandemic Influenza Preparedness (PIP) Partnership Contribution (PC).
  • Contributes to the development and implementation of guidelines related to regulatory system strengthening, including for example the implementation of quality management systems, and marketing authorization of pandemic influenza guidelines by national regulatory authorities and other key stakeholders at national levels.
  • Assesses regulatory preparedness of, and contributes to any subsequent support that is needed, to Member States, to accelerate access to pandemic influenza products.
  • Works in collaboration with regional and country offices in executing regulatory system strengthening and the sharing of knowledge, best practices and lessons learned.
  • Responsible for execution of workplans, on time reporting of results and outcomes for onward reporting to management and donors.
  • Undertakes other duties as assigned by Group Lead, CRS/RSS.
  •  

    REQUIRED QUALIFICATIONS

     

    Education

    Essential: University degree in Biology, Pharmacy, Chemistry, Biochemistry, Medicine, Microbiology or related sciences. Post graduate degree in Microbiology, biotechnology, bioengineering or related science.

    Desirable: Specialization in medicines and vaccine regulation and/or production and/or quality assurance.

     

    Experience

    Essential: At least 7 years' experience in regulation and production/control/quality assurance of medicines and vaccines and biologicals acquired by working with a medicines, vaccine manufacturer or national regulatory authority. At least two years' experience at international level. Experience in the implementation and management of collaborative projects at national and international/regional levels.

    Desirable: Relevant experience working with low and middle income countries.Familiarity with, quality management principles and project management.

     

    Skills

    Expertise in the regulation of medical products and good understanding of WHO's policies and strategies in this area. Good knowledge of product development, production and control. Recognized ability to work with experts at national, regional and international levels. Demonstrated ability to establish and maintain effective working relationships with people of different national and cultural background; and to supervise programmes, budgets, individuals and teams.

     

    WHO Competencies

    • Teamwork
    • Respecting and promoting individual and cultural differences
    • Communication
    • Producing results
    • Building and promoting partnerships across the organization and beyond

     

    Use of Language Skills

    Essential: Expert knowledge of English.

    Desirable: Intermediate knowledge of French.

     

    REMUNERATION

     

    WHO salaries for staff in the Professional category are calculated in US dollars. The remuneration for the above position comprises an annual base salary starting at USD 73,516 (subject to mandatory deductions for pension contributions and health insurance, as applicable), a variable post adjustment, which reflects the cost of living in a particular duty station, and currently amounts to USD 5483 per month for the duty station indicated above. Other benefits include 30 days of annual leave, allowances for dependent family members, home leave, and an education grant for dependent children.

     

    ADDITIONAL INFORMATION

     

    • This vacancy notice may be used to fill other similar positions at the same grade level
    • Only candidates under serious consideration will be contacted.
    • A written test may be used as a form of screening.
    • In the event that your candidature is retained for an interview, you will be required to provide, in advance, a scanned copy of the degree(s)/diploma(s)/certificate(s) required for this position. WHO only considers higher educational qualifications obtained from an institution accredited/recognized in the World Higher Education Database (WHED), a list updated by the International Association of Universities (IAU)/United Nations Educational, Scientific and Cultural Organization (UNESCO). The list can be accessed through the link: http://www.whed.net/. Some professional certificates may not appear in the WHED and will require individual review.
    • Any appointment/extension of appointment is subject to WHO Staff Regulations, Staff Rules and Manual.
    • Staff members in other duty stations are encouraged to apply.
    • For information on WHO's operations please visit: http://www.who.int.
    • WHO is committed to workforce diversity.
    • WHO's workforce adheres to the WHO Values Charter and is committed to put the WHO Values into practice.
    • WHO has a smoke-free environment and does not recruit smokers or users of any form of tobacco.
    • WHO has a mobility policy which can be found at the following link: http://www.who.int/employment/en/. Candidates appointed to an international post with WHO are subject to mobility and may be assigned to any activity or duty station of the Organization throughout the world.
    • Applications from women and from nationals of non and underrepresented Member States are particularly encouraged.

     

     

     

     ________________________________________________________________________

    This is how cinfo can support you in the application process for this specific position: 

     

    • Before you apply for this position: Improve your application documents by registering for a Job Application Support. 
    • When invited to the interview: Prepare for the interview by registering for a Job Application Support. This service is offered free of charge to Swiss nationals.  

     

    Interested in a career with multilateral institutions? Read more:
    Working with the United Nations
    Working with International Financial Institutions
    For Swiss nationals 

    ____________________________________________________________________________________ 


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Nutrition Management

Medair

Fully, VS
Vor 2 Tagen
Fully, VS
Vor 2 Tagen
Project Overview Multi-sector emergency response programme including provision of emergency health, nutrition and WASH services for vulnerable populations in South Sudan. Medair is launching a new long-term static site in Jonglei State South Sudan. The nutrition manager is one of the key team members supporting the start-up of this exciting new project. Our Culture Key Activity Areas Nutrition Management Undertake the implementation, management, supervision and support of the assigned nutrition field interventions in line with the activity plan and time frame of the relevant project proposal and any applicable national and international guidelines and standards. Conduct daily supervision to clinics and other nutrition facilities for support and supervision. Provide training for local staff in line with the appropriate international and South Sudan guidelines. Ensure that regular monitoring and evaluation of intervention implementation. Provide input into the integration of beneficiary participation and accountability in the project. Oversee the process of data collection, collation and dissemination to meet the requirements and deadlines. Ensure accurate and timely reporting of activities for reports requested by field managers, GSO and donors. Input into the development of the country strategy, new projects and/or donor proposals. Staff Management Assist the Project Manager to manage and oversee the assigned local nutrition team including recruitment, day-to-day management, development and training, appraisals, etc. The team may include certified health staff (e.g. medical assistants, nurses, midwives, community health workers), nutrition staff and support staff. Assist to facilitate regular team meetings with the assigned nutrition team, reviewing team and individual objectives, ensuring team members are kept informed of issues and providing an opportunity for feedback. Ensure the assigned nutrition team members receive relevant and appropriate supervision, coaching, mentoring and training in order to develop their personal and professional skills, knowledge and understanding. This may be through on-the-job training and taught sessions. Promote the health and security of the nutrition team by ensuring the application of security guidelines, health and safety in the workplace and healthy living conditions and practices. Assist in the recruitment of local field staff following all HR policies of Medair and the Government of South Sudan. Financial Management Work with the Project Manager and other Nutrition Managers to manage finances within the field location. Coordinate and oversee petty cash requirements of the intervention team, ensuring all required paperwork is completed accurately and in a timely manner. Communication and Coordination Maintain appropriate communication structures with the assigned nutrition team, Medair in-country health and nutrition managers and advisors and other relevant stakeholders. Represent Medair at local level coordination meetings involving local authorities, other NGOs, etc. Logistics Manage all stocks within the field location ensuring proper stock keeping records are in place. Manage the correct and timely ordering of needed stocks and supplies to the field location in coordination with the Project Manager. Quality Management Promote and use the Medair intranet and other operating procedures, ensuring that all standardised formats are used and guidelines are followed. Implement relevant policies and standards relating to service delivery including Sphere and HAP standards, Ministry of Health and donor guidelines and other good practice. Participate in Medair internal workshops and distance learning sessions to keep up with changing trends, new guidelines and best practices. Team Spiritual Life Reflect the values of Medair with team members, local staff, beneficiaries, and external contacts. Work, live, and pray together in our Christian faith-based team settings. Fully contribute to the rich spiritual life of your team, including team devotions, prayers, and words of encouragement. Encouraged to join and contribute to Medair’s international prayer network. This job description covers the main tasks that are anticipated. Other tasks may be assigned as necessary. Qualifications Degree in Foods, Nutrition and Dietetics, Health, Nursing, Medical or Public Health. Strong working knowledge of English (spoken and written). Relief & Recovery Orientation Course (ROC) What is the ROC and why is it required?
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Clinical trial Physician

Randstad Schweiz AG

Allschwil, BL
Vor 19 Tagen
Allschwil, BL
Vor 19 Tagen

Randstad Professionals is currently looking for a Clinical Trial Physician /Medical Doctor (Neuroscience) for a main client located in the surroundings of Basel.

This contracting position is a great opportunity to join a very successful global Pharmaceutical player. The company is in full development with major focus on US and EMEA. The position of clinical Trial Physician is open for immediate requisition. The initial contract will last until december 2020.

REQUIRED QUALIFICATIONS AND EXPERIENCE

• MEDICAL DOCTOR

• At least 4 year- experience in clinical research in a Pharmaceutical or Biotech company or equivalent in Academia

• Clinical research or Clinical experience in the indication relevant to the Clinical Project is preferred (multiple sclerosis)

• Good knowledge of drug development and clinical trial process based on previous experience

• Good knowledge of regulatory requirements/ICH guidelines

• Good organizational skills, able to work as part of a team and independently

• Good communication skills

• Detailed oriented

• Fluent in English

RESPONSIBILITIES AND TASKS

All tasks below should be performed in compliance with GCP and company’s SOP’s.

The CTP is a member of the Clinical Trial Team (CTT). The tasks and activities of the CTP are carried out in close collaboration with the Clinical Trial Scientist (CTS) for the trial related activities and with the Clinical Project Physician (CPP) and Clinical Project Scientist (CPS) for the project related activities.

Key Responsibilities:

• Developing a sound understanding of the science and medicine relating to Neuroscience

• Developing a sound understanding of the complexity of global clinical development with a particular attention to methodological and ethical aspects of development (Neuroscience)

• Performing literature reviews, and write position papers as necessary.

• Contribute to writing of Protocol and Core Informed Consent Form (CICF), including amendments

• Input into the Clinical Study Report (CSR).

• Medical training of the Clinical Trial Team (CTT) members and/or Actelion staff .

• Medical oversight of the study (including safety, quality and performance of the trial).

• Clinical Trial results interpretation.

• Involved in the organization and management of external activities (Contacts with external Experts, Steering Committees (SC), Independent Data Monitoring Committees (IDMC)).

• Answering to trial-related EC/IRB and HA questions.

• Ensuring that the Case Report Form is designed to allow careful and comprehensive collection of data

If you are interested to learn more about this great opportunity, don’t hesitate to get in touch with me. Feel free to send me your CV at following email

olivier.worch@randstad.ch

I am looking forward to receiving your applications

Olivier Worch


Reference:14558

Stellentyp

Vollzeit

Veröffentlicht

Vor 1 Tag