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Regulatory Administrator – 10 month FTC Location: High Wycombe Salary: £25k pa, pro rata (negotiable for the right person) The company: I am delighted to work with a well-established, global Medical Device company that is present in 40 countries and have a wide range of medical device products. About the role: They are looking to expand their Regulatory Affairs team, and searching for an entry level Regulatory Affairs Assistant to complete their busy team on a Fixed Term Contract until the end of 2020. This will likely become a permanent role. The role is ideal for someone who has 1 or 2 years of experience within Regulatory Affairs as an Administrator, Assistant or Associate and is looking to gain more exposure with a very successful Medical Device company. Training will be provided. Key responsibilities: * Regulatory data entry * Administrate Medical Documentation and NPI projects * Technical file amendments * Ensuring files and documents are handled efficiently and correctly * Support the compliance and marketing teams Key competencies and experience: * Guate with a scientific degree * Good communication skills * Great eye for detail * Interest in Regulatory Affairs * Previous experience in RA or Medical Devices is welcome but not essential * High level competency with MS suites Keywords: Regulations, Regulatory, RA, med dev, medical device, devices, submissions, graduate, BA, Msc, Bsc, degree, graduated Harris Lord is acting as a recruitment agency for this role
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CK Group are recruiting for a CSV Engineer to join a company in the Pharmaceutical industry at their site based in Dun Laoghaire on a 12 month contract basis. Hourly rate for LTD contractors is €44.16. The Company: Our client is one of the worlds leading manufacturers of biosimilar and biopharmaceutical products used in the treatment of a wide range of human healthcare conditions from cancer to arthritis. This company are a strong believer in helping patients by developing new treatments and taking them to market via their global network of specialist aseptic manufacturing, packaging and distribution sites. The Location: This role is located on a state of the art manufacturing facility based in Dun Laoghaire and is a quick 30 minute drive away from the centre of Dublin, or 60 minutes drive from Dublin Airport. The site is easily commutable from Kildare or Wicklow by car and there is a good public transport network if you would prefer to live within Dublin itself. Dun Laoghaire is a vibrant cultural hub in south Dublin which is best known for its maritime history and locally caught sea food. The Role: Development of Validation Plans, Installation Qualifications (IQs), Operational Qualifications (OQs) and Summary Reports. Review and Approve validation protocols and assessments from a quality system documentation perspective.  Prepare, execute, document and report validation protocols in line with GMP's and other regulatory requirements and standards. Participate and communicate as required in project activities. Your Background: Candidates must have at least 5 years' experience in GMP Regulated Environment. Computer system validation lifecycle is essential. Working knowledge of GAMP software development lifecycle. Bachelor of Science/Engineering degree or equivalent. Entitlement to work in the EEA is essential. Please quote reference 47768 in all correspondence. INDDIF
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A contract assignment based in Bracknell A great opportunity to work in a fast paced office environment Client Details A multinational market research company Description You will be responsible for all scheduling of recruitment for the UK offices Liaising with agencies Updating recruitment trackers Communicating with candidates and ensuring the process is run as smoothly as possible Posting job adverts Shortlisting Conducting initial phone screeningsProfile Previous recruitment administration experience is essential You must be able to work effectively in a fast paced environment The ability to work independently with minimal hand holding You will be able to build good relationshipsJob Offer Modern offices in Bracknell The chance to be a part of a global company Competitive salary
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The successful candidate will provide guidance and direction to manager and employees regarding non-complex, routine issues including probation's, performance management etc. This is an intermediate level position and is responsible for managing ER issues and case documents.Client Details A leading research organisation providing services to pharmaceutical industries.Description Advising and counselling managers on routine performance issues and early stage coaching with the intended goal of growing manager's expertise. Conduct ER investigations and consult with the ER Manager and Legal. Responsible for tracking and analysing ER metrics. Advising on disciplinary and other formal processes in accordance with policies and guidelines. Leading/participating in various employee relations projects and activities. Delivering and and coordinating skill building training for managers. Managing less complex ER cases. Formal meeting coordination including note taking. All other duties as required.Profile Proven HR and basic ER experience. Knowledge of relevant employment laws. Ability to interpret policies and ability to refer managers to relevant policies, tools, documents etc. Ability to maintain confidentiality with sensitive issues. Skilled at prioritising issues that are time-sensitive. Proven organisational skills. Exceptional verbal and written communication skills. Good standard of education. CIPD qualified or working towards is desirable.Job Offer Modern offices with parking Competitive salary
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For our client in Kairgaust we are looking for SAP Plant Maintenance/SAP Asset Manager Senior Solutions Architect for a 10 months contract.

Background

The job posting has been re-submitted, as the right candidate could not be identified yet. Please don't upload candidates which have already been rejected on the posting.

Strong focus will be on candidates with hands-on experience on system configuration in SAP PM Module and with good business knowledge in Plant Maintenance area.

Aspire is a multi-year program which aims at defining and developing the functional ERP roadmaps in order to simplify, standardize and automate business processes and systems leveraging SAP's, industry and available best practices. As the Asset Manager IT Solution Architect, you are responsible for delivering IT solutions that fulfil the business requirements in the area of ERP PM (Plant Maintenance) within the Aspire program. In this role, you report to the Global ERP PT IT Lead.

The perfect candidate is a very hands-on and experienced Solutions Architect in the area of SAP Plant Maintenance and SAP Asset Manager. He/she is used to work in a global pharmaceutical company and has preferably proven experience in the implementation of the new SAP S/4 Hana system.

General information

Start date: 16.03.2020 (ASAP)
Latest start date: 16.03.2020
End date: 31.12.2020
Extension: Extension possible, needs to be approved
Workload: 100%
Work location: Kaiseraugst
Remote: max. 1 day per week (Friday)/prior approval needed
Travel: 10%
Team: 6

Tasks & Responsibilities

* Define, design, build and oversee the implementation and rollout of ERP functional solutions based on SAP S/4 HANA for Plant Maintenance (PM) with SAP Asset Manager as future mobile maintenance solution
* Ensure the solution fits to the business requirements and the end to end technical operations processes including systems, interfaces and platforms
* Collaborate with the program and business teams to ensure continuous business and IT alignment
* Collaborate with functional and IT teams working closely with the Plant Maintenance, especially IT Architecture and Master Data
* Manage and guide suppliers' resources working in the PM area
* Work closely with PMO to ensure effective project governance, management and timely reporting of progress on activities and work packages according to the program plan and milestones
* Ensure smooth handover of the solution and the systems built to the support and operations teams

Must Haves

* 10 years of experience in a global enterprise in the Pharma industry, delivering ERP solutions in transformational projects (*)
* 10 years of hands on experience in delivering ERP PM solutions, preferably in Pharma/healthcare industry with excellent Business Process knowledge in the area of Plant Maintenance (*)
* 5 years of hands on experience in delivering SAP mobile maintenance solutions (SAP Work Manager, SAP Asset Manager) preferably in Pharma/healthcare industry (*)
* Very good understanding of SAP Enterprise Asset Management (MobileAdd-on) and SAP Cloud Platform (Mobile Services, Mobile Development Kit, SAP Web IDE) At least one proven Asset Manager implementation, please provide information on reference & role (*)
* Good knowledge of S/4 HANA (*)
* Excellent interpersonal skills in large multi-national enterprise as well as experience in delivering projects using project management methodology (PMM) or equivalent
* Fluent in English (written and spoken)

Nice to Haves

* Former Pharma experience
* Conversational in German language

For more information please contact Barbara Tenerowicz:
E: (see below)

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Job Description

  • Direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase.
  • Build relationships with investigators and site staff.
  • Conduct, drive and manage country-specific feasibility and/or site prequalification and qualification activities, which may include:
  • Preparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs) and any amendments.
  • Conduct remote Qualification Visits (QVs).
  • Generate visit/contact reports, using judgment to identify site issues and problem solving to direct resolution.
  • Develop a strategy to configure, distribute, and collect, and review and approve, high quality country-specific and/or site-specific documents or essential regulatory documents (SRP) and any updated or amended regulatory documentation.
  • Customize, review, and negotiate as needed, country/site-specific Informed Consent Forms (ICF), translations (within parameters of country/regulatory/client requirements), and customize and negotiate any amendments.
  • Prepare and submit IRB/IEC and MoH/RA (if applicable) application(s), resolving conflicts, determining appropriate follow up until receipt of final approval.
  • Submit all pertinent documentation to the trial master file as per project plans/sponsor/company policy.
  • Forecast, develop, manage, and revise plans and strategies for:
  • IRB/IEC and MoH/RA submission/approval,
  • Site activation,
  • Patient recruitment & retention.
  • Update and maintain appropriate Clinical Trial Management systems (CTMS) in a timely manner.
  • Promptly identify, use judgment and knowledge to address and resolve or escalate, any site question and/or issue, including but not limited to: potential issues or risks with site activation timelines, issues with patient recruitment strategy, deficiencies in training, data quality or integrity, study non-compliance, etc.
  • Facilitate and support allocated sites with access to relevant study systems and ensure they are compliant with all project-specific training requirements prior to study start.
  • Actively participate in Investigator and other external or internal meetings, audits & regulatory inspections.
  • Work in a self-driven capacity, with a limited need for oversight.

Skills:

  • Direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase.
  • Build relationships with investigators and site staff.
  • Conduct, drive and manage country-specific feasibility and/or site prequalification and qualification activities, which may include:
  • Preparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs) and any amendments.
  • Conduct remote Qualification Visits (QVs).
  • Generate visit/contact reports, using judgment to identify site issues and problem solving to direct resolution.
  • Develop strategy to configure, distribute, and collect, and review and approve, high quality country specific and/or site-specific documents or essential regulatory documents (SRP) and any updated or amended regulatory documentation.
  • Customize, review, and negotiate as needed, country/site specific Informed Consent Forms (ICF), translations (within parameters of country/regulatory/client requirements), and customize and negotiate any amendments.
  • Prepare and submit IRB/IEC and MoH/RA (if applicable) application(s), resolving conflicts, determining appropriate follow up until receipt of final approval.
  • Submit all pertinent documentation to the trial master file as per project plans/sponsor/company policy.
  • Forecast, develop, manage, and revise plans and strategies for:
  • IRB/IEC and MoH/RA submission/approval,
  • Site activation,
  • Patient recruitment & retention.
  • Update and maintain appropriate Clinical Trial Management systems (CTMS) in a timely manner.
  • Promptly identify, use judgment and knowledge to address and resolve or escalate, any site question and/or issue, including but not limited to: potential issues or risks with site activation timelines, issues with patient recruitment strategy, deficiencies in training, data quality or integrity, study non-compliance, etc.
  • Facilitate and support allocated sites with access to relevant study systems and ensure they are compliant with all project-specific training requirements prior to study start.
  • Actively participate in Investigator and other external or internal meetings, audits & regulatory inspections.
  • Work in a self-driven capacity, with a limited need for oversight
Skills
  • Able to take initiative and work independently, and to proactively seek guidance when necessary.
  • Excellent presentation skills.
  • Client-focused approach to work.
  • Ability to interact professionally within a client organization.
  • A flexible attitude with respect to work assignments and new learning.
  • Ability to prioritize multiple tasks, and achieve project timelines; utilizing strong analytical skills to make decisions autonomously due to the unpredictable nature of the issues that arise.
  • Strong ability to make appropriate decisions in ambiguous situations.
  • Willingness to work in a Matrix environment and to value the importance of teamwork.
  • Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS Office products such as Excel and Word.
  • Excellent interpersonal, verbal, and written communication skills.
  • Sense of urgency in completing assigned tasks and the ability to assist others to meet study/country deliverables.
  • Excellent time management in order to meet study needs, team objectives, and department goals.
  • Proven ability to work across cultures.
  • Shows commitment to and performs consistently high-quality work.
  • Ability to successfully work in a ('virtual') team environment.
  • Consulting Skills.
  • Able to accommodate travel time requirements, according to tasks allocation/phase of the study assigned.
  • Act as a mentor and role model for other team members.
  • Effectively enlist the support of team members in meeting goals.
  • Attention to detail.
  • Holds a driver's license where required.

Michael Bailey International is acting as an Employment Agency in relation to this vacancy.

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SAP Solution Architect - SAP Plant Maintenance - SAP Asset Manager - SAP Cloud Platform - Hands-on experience in SAP mobile maintenance solutions - Mobile Development Kit - S/4 HANA - PMM - Pharmaceutical - English - German - Switzerland - NextLink Solutions

NextLink is looking for an experienced SAP Solution Architect to join their exciting project in Switzerland. Are you looking for new roles and this sounds like a good fit?

See more information about the role below and let me know what you think:

General information:

Start date: 16.03.2020 (ASAP)

Latest start date: 16.03.2020

End date: 31.12.2020

Extension: Extension possible, needs to be approved

Workload: 100%

Remote: max. 1 day per week (Friday)/prior approval needed

Travel: 10%

Team: 6

Responsibilities:

Define, design, build and oversee the implementation and rollout of ERP functional solutions based on SAP S/4 HANA for Plant Maintenance (PM) with SAP Asset Manager as future mobile maintenance solution
Ensure the solution fits to the client's business requirements and the end to end technical operations processes including systems, interfaces and platforms
Collaborate with the program and business teams to ensure continuous business and IT alignment
Collaborate with functional and IT teams working closely with the Plant Maintenance, especially IT Architecture and Master Data
Manage and guide suppliers' resources working in the PM area
Work closely with PMO to ensure effective project governance, management and timely reporting of progress on activities and work packages according to the program plan and milestones
Ensure smooth handover of the solution and the systems built to the support and operations teams

Must haves:

10 years of experience in a global enterprise in the Pharma industry, delivering ERP solutions in transformational projects.
10 years of hands on experience in delivering ERP PM solutions, preferably in Pharma/healthcare industry with excellent Business Process knowledge in the area of Plant Maintenance.
5 years of hands on experience in delivering SAP mobile maintenance solutions (SAP Work Manager, SAP Asset Manager) preferably in Pharma/healthcare industry.
Very good understanding of SAP Enterprise Asset Management (MobileAdd-on) and SAP Cloud Platform (Mobile Services, Mobile Development Kit, SAP Web IDE) At least one proven Asset Manager implementation, please provide information on reference & role.
Good knowledge of S/4 HANA.
Excellent interpersonal skills in large multi-national enterprise as well as experience in delivering projects using project management methodology (PMM) or equivalent
Fluent in English (written and spoken)

Nice to have:

Conversational in German language

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Junior Data Modeler Manufacturing Execution Systems in Basel

Background:
For the MES Business Management Team we are looking for a temporary employee to support our Manufacturing Execution Systems in the manufacturing area in Kaiseraugst. Your main responsibility will be the support of the Manufacturing Execution System. You will model and test master recipes, specify and test new system functions and perform the 1st Level Support for our end users. You will be in close collaboration with Business, Quality Assurance and IT and will also support running projects. To be prepared for the job an intensive training will be carried out at the beginning of the employment.
The perfect candidate has a proven background working with MES Systems, ideally with PMX or Pharma Suite and is able and willing to provide a 7 by 24 stand by support if needed. Stand by support can normally be provided from home without the need to be physically in the manufacturing area.
German language in written and spoken is a must.

Role:
* Implementation and validation of systems and IT processes in the manufacturing area
* Production master recipe modelling and testing including master data management
* 1st Level Support
* Support of Projects
* Data Analytics and Reporting
* Close collaboration with internal and external partners like Business, Informatics, Engineering and Suppliers

Requirements:
* 2-4y proven experience in specifying, configuring, testing and documenting of systems and applications in a GMP environment
* 2-4y experience in Manufacturing Execution Systems (MES)
* Knowledge of Rockwell Automation Systems (PMX/Pharma Suite)
* Experience working in an Interface position between Business/IT/Engineering/QA
* Ability and willing to support 7 by 24 stand by duty
* Fluent in written and spoken German and English
* You are self-reliant, resilient, flexible and have a high service orientation
* Good technical understanding with good networked thinking
* Good communication skills

Nice to Haves
* Degree in informatics or engineering

Reference: 919078
Industry: Pharma
Location: Region Basel
Start: ASAP
Duration: 12 Months
Work Load: 100%

About us:
ITech Consult is a certified ISO 9001:2015 Swiss company with offices also located in Germany and Ireland. ITech Consult is specialised in delivering IT candidates for contract work. We were founded in 1997 by IT professionals; hence we well understand what it means to be professionally supported in your search for a new project and being employed.

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Projekt:
For our customer Hoffman La Roche in Basel we are looking for a highly qualified Long-term Senior Program Manager for Pharma Informatics.

Background

The job posting has been re-submitted, as the right candidate could not be identified yet. Please don't upload candidates which have already been rejected on the posting.

Strong focus will be on candidates with hands-on experience on system configuration in SAP PM Module and with good business knowledge in Plant Maintenance area.

Aspire is a multi-year program which aims at defining and developing the functional ERP roadmaps in order to simplify, standardize and automate business processes and systems leveraging SAP's, industry and available Roche best practices. As the Asset Manager IT Solution Architect, you are responsible for delivering IT solutions that fulfil the business requirements in the area of ERP PM (Plant Maintenance) within the Aspire program. In this role, you report to the Global ERP PT IT Lead.

The perfect candidate is a very hands-on and experienced Solutions Architect in the area of SAP Plant Maintenance and SAP Asset Manager. He is used to work in a global pharmaceutical company and has preferably proven experience in the implementation of the new SAP S/4 Hana system.

Tasks & Responsibilities

* Define, design, build and oversee the implementation and rollout of ERP functional solutions based on SAP S/4 HANA for Plant Maintenance (PM) with SAP Asset Manager as future mobile maintenance solution
* Ensure the solution fits to the Roche business requirements and the end to end technical operations processes including systems, interfaces and platforms
* Collaborate with the program and business teams to ensure continuous business and IT alignment
* Collaborate with functional and IT teams working closely with the Plant Maintenance, especially IT Architecture and Master Data
* Manage and guide suppliers' resources working in the PM area
* Work closely with PMO to ensure effective project governance, management and timely reporting of progress on activities and work packages according to the program plan and milestones
* Ensure smooth handover of the solution and the systems built to the support and operations teams

Must Haves

* 10 years of experience in a global enterprise in the Pharma industry, delivering ERP solutions in transformational projects (*)
* 10 years of hands on experience in delivering ERP PM solutions, preferably in Pharma/healthcare industry with excellent Business Process knowledge in the area of Plant Maintenance (*)
* 5 years of hands on experience in delivering SAP mobile maintenance solutions (SAP Work Manager, SAP Asset Manager) preferably in Pharma/healthcare industry (*)
* Very good understanding of SAP Enterprise Asset Management (MobileAdd-on) and SAP Cloud Platform (Mobile Services, Mobile Development Kit, SAP Web IDE) At least one proven Asset Manager implementation, please provide information on reference & role (*)
* Good knowledge of S/4 HANA (*)
* Excellent interpersonal skills in large multi-national enterprise as well as experience in delivering projects using Roche project management methodology (PMM) or equivalent
* Fluent in English (written and spoken)

Nice to Haves

* Former Roche experience
* Conversational in German language

Reference No.:918984SGR
Role: SAP Plant Maintenance/SAP Asset Manager Senior Solutions Architect
Industry: Pharma
Location:
Kaiseraugst
Workload: 100%
Start: ASAP
Duration: 12

Should you find yourself suitable for this position then please send us your complete CV using the link in this advert. If the position is not a perfect match and you wish to receive other opportunities directly, you can send us your CV anyway via this advert

About us:

ITech Consult is a certified ISO 9001:2015 Swiss company with offices also located in Germany and Ireland. ITech Consult is specialised in delivering IT and Life Science candidates for contract work. We were founded in 1997 by IT professionals; hence we well understand what it means to be professionally supported in your search for a new project and being employed.

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For our Pharma client based in Zurich, we are looking for a

Brand Manager (Dermatology) - 100%

Tasks & Responsibilities:

  • Develop the brand 5-year strategic plan by defining the strategic imperatives and identifying the appropriate commercial activities and product innovation plan to deliver against them
  • Define the qualitative and quantitative marketing goals for the year (budget, marketing plan etc.)
  • Monitor results on the market, propose proactively corrective actions and lead their timely implementation to meet market share and financial targets
  • Coordinate with other functions for all the activities related to brands: pricing, promotion, communication, new launches, etc.
  • Responsible for the communication of the brand (on-pack, on/offline, in-store, etc.) to be in line with brand positioning and objectives, and validated from local LMR departments (Legal/Medical/Regulatory)
  • Direct relationship with Global Marketing and active member of Global Brand teams (Brand Acceleration Teams, Brand Community, etc.)

Your Profil:

  • Degree in Business Administration or similar school, as well as a Degree in Pharmacy, Science or Nutrition or Diploma as Pharmacist etc.
  • Minimum of 3 years of experience in Brand Management, Marketing or Sales
  • Experience in Pharma or FMCG industry are preferred, as well as experience in Digital Marketing or E-commerce
  • Experience in Dermatology would be highly desired
  • Self-driven leader with the ability to manage multiple assignments and drive projects
  • Strategic mindset, results-oriented and with entrepreneurial spirit
  • Convincing, persistent and challenging the status quo
  • Good communication and interpersonal skills, team and networking mindset
  • Solid analytical skills
  • Fluency in German and English, both spoken and written
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