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  • Project Management

    €40000 - €45000 per annum
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    We are recruiting on behalf of our client an oncology company that explores develops and establishes a fundamentally different type of cancer therapy called tumor therapy fields TTFields which are used to treat solid tumors a Clinical Application Specialist in Augsburg Munich area or Cologne area

    Your responsibilities

    Conducting patient and relatives training or retraining on medical devices

    Regular check of the correct application and function of the device on site at the patient

    Independent solving of technical and application related difficulties Here you can count on the support of a specialist team

    Independent planning and organization of your appointments and the associated administration

    Care of a patient base in a larger radius about 200km Flexibility to help out in other regions in the short term

    Our requirements

    Completed education in the medical nursing field

    Experience in dealing with people in difficult situations

    Safe handling of modern means of communication MS Office as well as the willingness to work in other software programs

    A valid Class B driving license

    Ideally first experiences in field service

    Good self organization and independent way of working

    Very good German and good English skills

  • UK

    Project Management

    £90000 - £110000 per annum, Benefits: Benefits
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    Director Regulatory Affairs

    A fantastic opportunity to join an innovative bio pharmacetical company that is recruiting for a Director (post marketing) appointment.

    This opportunity will position you as a leading member within a bio pharma which, has had products approved every year since 2016. Providing an exceptional package consisting of salary, stock options and top-tier benefits.

    As Director you will be a key stakeholder in the company’s regulatory activities and oversee the activities of product development and life cycle management for established products. You will be liasing with authorites globally to market products. As Director of Regulatory Affairs you will manage worldwide interactions and negotiations with stakeholders, agencies and partners to ensure continuity of supply. Strong leadership and strategic implementation is a key focus for this role.

    You will be responsible for managing partnerships from a regulatory standpoint for products/projects and the review and approval of labelling for the company’s products. You must have strong experience with documentation in support of commercial products (I.e. clinical protocols/CSRs and investigator brochures, quality, nonclinical, safety) and ensure the timely preparation, review, and submission of investigational and product submissions such as INDs/CTAs/IMPDs, MAAs/BLAs/NDAs and variations for products/projects.

    As Director you will oversee direct reports in preparation and management of above responsibilities and assist as needed. This exciting role requires you to have a deep and broad knowledge of regulatory affairs and direct experience with biological and/or pharmaceutical regulatory submissions and product approvals. You must have a proven track record of effective collaboration with regulatory agencies knowledge and experience in preparation of investigational and new product submissions with EU, US, and ex-US countries including eCTD format as well as experience in preparation of global regulatory strategies

    A proven record of maintenance of regulatory authorizations and variations in at least two regions and supporting a project with development activities in at least two regions is desirable.

    This Director of Regulatory Affairs role is an office-based position based is in the Oxfordshire area. Offering a competitive salary and package.

    Skills Alliance is a preferred supplier for this opportunity. Please contact Iman Osman for more details on +44 207 220 6220.
    #IODPMJ

  • UK

    Project Management

    £40000 - £55000 per annum, Benefits: benefits
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    I am partnered with mid-sized Pharma company specialising in Oncology who are seeking a Junior Study Manager to join their growing team. This is a great opportunity for an experienced CRA to join move away from monitoring and into project management.

    You will be responsible for coordinating phase III studies whilst also managing a small-scale study. The Junior Study Manager role will also encompass vendor management of the CRO.

    Experience:

    • 3 years independent monitoring experience within CRO or Pharma.
    • Experience working in complex therapy areas.
    • Experience coordinating studies advantageous

    For more info please contact Troy Neenan on 02072206237.

  • UK

    Project Management

    £40000 - £50000 per annum, Benefits: benefits
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    I am partnered with a reputable CRO who are looking for an experienced CRA to join their team. This is a rare opportunity to move into a regionalised monitoring role whilst working in more of a quality driven environment. This is an ideal position for someone who is tired of national monitoring and is keen to work in a less metrics driven environment.
    Responsibilities:

    • Responsible for routine site visits
    • Start-up activities
    • Mentoring and training of CRAs

    Experience:

    • 18 months + independent monitoring experience
    • Experience working in complex therapy areas
    • Scientific degree or equivalent

    For more information please call Troy Neenan on 02072206237 or click apply.

  • Data & Analytics

    Competitive
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    Drug Safety Manager

    An expanding CRO is recruiting for a Drug Safety Manager to join their growing team based in Finland.

    This opportunity will see you take a strong lead in their growing safety services, with an international (focus on Europe, collaboration in US and Japan).

    As Drug Safety Manager you will be offered an interesting position that will give you the opportunity to work with an internationally-growing CRO. You will be part of business-minded surroundings working with experts in the field.

    You are warmly welcome to the team if you are/have:

    • Broad experience in pharmacovigilance/drug safety, with knowledge of medical terminology and GVP
    • Sales/business-oriented
    • Experience in leadership
    • Able to understand business
    • Project management skills
    • Effective communication skills (written and spoken)
    • A good command of Finnish and English (written and spoken)
    • This is a full-time opportunity offering a competitive salary.

    This is an office based role in Finland that offers home based flexibility.

    Skills Alliance is a preferred supplier for this opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    Reference #IODSMM

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    Senior Regulatory Affairs Associate

    As Senior Regulatory Affairs Associate you will have the opportunity to work alongside committed and dynamic investigators and sponsors, progressing important and exciting oncology studies.

    You will have the chance to work with a highly experienced team, in an environment that is flexible exposing you to a rapidly changing clinical trials environment. Meaning, you will be able to progress projects from inception to completion in a fast-paced environment.

    As Senior Regulatory Affairs Associate you will have the opportunity to work on fascinating scientific developments and discoveries whilst being challenging and constantly rewarded.

    Main responsibilities include –

    • Management, preparation, assembly and submission of European:
    • Clinical Trial Authorisation Applications (CTAA) and amendments.
    • Country-level Informed Consent and other patient facing documentation.
    • Tracks, reports and files CTAA and amendment submission/approval progress in electronic trial master files (eTMF), clinical trials management system (CTMS) or other applicable systems.
    • Provides consultancy to the client on European CT regulatory specific issues.
    • Participates in the quality control (QC) steps involved for all of the above.
    • Serves as key regulatory liaison for multi-continental projects on behalf of Oncology (Europe). Liaison with other departments within including Data Management, Medical Writing, Pharmacovigilance, Quality Assurance and Drug Distribution.
    • Maintains an awareness of the literature on cancer therapy, clinical trial design and conduct, Good Clinical Practice, and regulations and guidelines relating to the conduct of clinical trials produced by regulatory agencies and ethics committees.
    • Provides regulatory training to other members of the team, as required.

    This is a full-time opportunity offering a competitive salary and office / home-based flexibility.

    Skills Alliance is a preferred supplier for this opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    Reference #IOSRAT

  • UK

    Project Management

    £30000 - £40000 per annum
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    I am working with a growing Biotech focused in Gene Therapy who are looking for an experienced Clinical Trial Assistant to join their team. This is a rare opportunity to get full exposure to complex studies and take on a wide range of responsibilities, you will also work closely with the Director of Clin Ops.

    This is a fully office based position in Hertfordshire offering a flexible salary between £30,000 – £40,000 plus benefits.

    Experience:

    • 2 years plus experience within CRO or Pharma
    • TMF/E-TMF experience required
    • Experience working in a fast paced and dynamic environment an advantage

    For more info please contact Troy Neenan on 02072206237.

  • Data & Analytics

    €200000 - €250000 per annum
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    Unser Klient führt mehrere Krankenhäuser in der Schweiz. Das ganze medizinische Spektrum wird an allen Standorten verteilt angeboten.

    Zur verstärkung des Teams suchen wir deshalb noch ein/e Leitender Arzt / Leitende Ärztin für die Pneumolgie.

    Was Sie erwartet:

    • Co-Leitung der Abteilung für Pneumolgie mit Aussicht auf Gesamtleitung
    • Sie decken das ganze Spektrum der klinischen Pneumologie ab
    • Weiterbildung des Personals

    Was Sie mitbringen:

    • Facharzttitel für Pneumologie
    • Fähigkeitsausweis Schlafmedizin
    • Erfahrung in einer Kaderposition ist erzwingend
    • Ausgezeichnete Kenntnisse im Bereich der gesamten Innere Medizin

    Ihre Vorteile

    • attraktive Karrieremöglichkeiten
    • motivierendes Arbeitsklima
    • hohe Qualitätsstandards

    Diskretion steht bei uns an erster Stelle. In einem vertraulichen Gespräch geben wir Ihnen gerne mehr Auskunft über die vakante Stelle.

    Jessica Demirtas
    Recruitment & Consultant DACH
    +41 43 508 73 11
    jessica.demirtas(at)skillsalliance.com

  • Data & Analytics

    €25000 - €30000 per annum, Benefits: car
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    We are recruiting on behalf of our client a global manufacturer of innovative laboratory products liquid handling purification and extraction solutions a Field Service Technician for Lyon area

    Promotes the company and performs repair calibration and preventive maintenance of the company and competitor pipettes at customer sites and maintains necessary documentation of this work

    Tasks

    Visits customer sites including university government and industry laboratories to perform calibration maintenance and repair on customer s pipettes

    Works with the Sales Representative to promote service and provide technical support

    Works with area representatives to cultivate new and repeat service accounts

    Works independently as well as with other team member to meet annual service targets

    Contacts existing service customers regarding ongoing needs if required

    Responds promptly and professionally to all customer inquiries

    Maintains familiarity with competitor service companies their practices and offers

    Determines customer s service needs coordinates accordingly

    Uses computer software to record serial number assign work order number to each job and to record calibration findings

    Performs calibration according to manufacturer ISO8655 or customer s own specifications

    Disassembles cleans inspects repairs and reassembles pipettes Is responsible for diagnosing problems if any and determining necessary repairs

    Reads and interprets technical diagrams of pipettes

    Uses small hand held tools to perform calibration and repair

    Ensures conformance with established calibration and repair standards

    Completes necessary paperwork and collects signatures and purchase orders from customers

    Maintains repair and calibration equipment and monitors parts inventory

    Responsible for proper execution of prescribed safety procedures when handling equipment and hazardous materials

    Contact possible with equipment that has been contaminated by laboratory chemicals human bodily fluids or other potentially hazardous substances

    Occasionally assists the Sales Representatives and distributor representatives with equipment demonstration at customer sites along with vendor and trade shows

    Reports any concerns regarding the company products observed in the field

    Supports customers within a particular MLH territory but travels to support other territories when necessary

    Attends regular training sessions including onsite and online in order to maintain professional and technical knowledge

    Utilizes problem solving skills to work with pipettes and troubleshoot any potential issues effectively to the satisfaction of the customer while maintaining Gilson s standards

    Follows the procedures regarding equipment maintenance field calibration and all other aspects of

    pipette service

    SKILLS OR KNOWLEDGE

    Ability to read and follow instructions as posted

    Ability to communicate effectively with others

    Ability to accurately pipette to the company Standard

    Mechanically inclined

    Strong computer skills

    Ability to manage a busy schedule with relative independence

    PHYSICAL ABILITY

    Requires good or corrected vision

    Good manual dexterity

    Ability to lift 25kg

    Must speak English and write Englist legibly
    Must have valid driver s licence good driving record and reliable transportation are required
    occasional overnight travel may be required up to 50

    ADDITIONAL SKILLS EXPERIENCE DESIRE

    Previous laboratory experience

  • UK

    Project Management

    £30000 - £35000 per annum, Benefits: benefits
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    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

    Before applying for this position you need to submit your online CV. Click the button below to continue.


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    I am working with a growing Biotech focused in Gene Therapy who are looking for an experienced Clinical Trial Assistant to join their team.

    This is a rare opportunity to get full exposure to complex studies and take on a wide range of responsibilities, you will also work closely with the Director of Clin Ops. This is a fully office-based position in Central London offering a flexible salary between £30,000 – £35,000 plus benefits.

    Experience:

    • 2 years plus experience within CRO or Pharma
    • TMF/E-TMF experience required
    • Experience working in a fast paced and dynamic environment an advantage

    For more info please contact Troy Neenan on 02072206237.