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  • Regulatory Affairs

    $140000 - $180000 per annum
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    I have an exciting Regulatory Strategy opportunity in New Jersey with a BioPharmaceutical Company noted for their positive and supportive work culture and environment, for someone specialized in Injectables and/or Combination Products in the Biopharmaceutical Industry.

    Reporting into the VP of Regulatory Affairs the essential function will include but is not limited to supporting and assisting the Vice President with regulatory strategy and product development, compliance and review of regulatory documents, compilation of regulatory dossiers (IND, NDA), and acting as point of contact when collaborating with regulatory authorities.

    Ideal Candidate will be coming from previous experience with Combination Products/and or Injectables, at least 5 years of Regulatory Strategy and submissions experience (IND, NDA, etc.), US FDA experience, strong working knowledge and understanding of regulatory regulations and guidelines, and strong writing and communication skills.

  • HR and talent acquisition

    Competitive
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    A growing Biopharmaceuticals company has a brand-new opening for an HR Business Partner to support the organisational growth and development of this unique company across Japan.

    The Human Resources Business Partner will work closely with Business Leaders to build and enhance this world class organisation through strategic and operational execution of a world class HR function.

    A fantastic opportunity for an experienced HR professional to contribute their innovative ideas to a patient-centric company whose culture is defined by its values and beliefs.

    Responsibilities:

    • Partner with Country Leaders to advise on both business and people related matters
    • Deliver high level consulting skills to influence, coach and feedback to employees of all levels
    • Partner with Country Leadership team to build and maintain a culture that drives performance, and attracts and retains top talent
    • Develops and implements initiatives around training and performance management
    • Contribute to the design and leadership of training programmes, leadership development programmes and succession planning
    • Translate core capabilities needed to drive business results into actionable development programmes for the team
    • Partner with the Head of Talent Acquisition to develop recruitment processes and lead recruitment activities at a country level

    Experience and Qualifications:

    • Significant experience as a Human Resources Business Partner responsible for organisational effectiveness and change management, learning and development and talent management strategies
    • Expert in Japanese employment law
    • Experience working within a global Pharmaceuticals or Research and Development organisation
    • Experience in the strategic development and implementation of HR initiatives

    Why Apply?

    • Opportunity to work for a patient-centric company with outstanding values and company culture
    • Play a key part in the growth and organisational development of a leading Biopharmaceuticals company
    • Partner closely with colleagues within an international environment

    Contact Sarah Brambill from Skills Alliance to apply or for more information.

  • USA

    Pharmacovigilance

    $115000 - $125000 per annum
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    This is an excellent opportunity to join a dynamic global specialty pharmaceutical company that are exponentially growing their team within the Greater Philadelphia area.

    As the Drug Safety Manager, you will be primarily responsible for the management of Individual Case Safety Report processing for branded and generic products. The successful applicant will have the exciting opportunity to manage a small team of Drug Safety Associates to ensure case processing activities are being executed properly.

    In this role, you will be responsible for guaranteeing safety reporting and case processing are accurately meeting regulatory guidelines and company processes by managing team day to day operations. You will also be responsible for assisting in the development of safety processes and case processing guidelines. Monitoring case processing workflow and adverse event information to input into the safety database will be an important aspect to this role as well.

    You must have a Bachelor’s Degree in a life sciences discipline and a minimum of 8 years of Pharmacovigilance and/or Drug Safety experience in a pharmaceutical setting. Having an advanced degree as well as past management experience would be looked at extremely favorably.

    The company is one of the most unique in the industry with a proven track record of success in the branded and generic pharmaceutical space both domestic and abroad. With recent successful Phase 3 results, this is the right time to be joining this truly innovative team!

    If you are interested in more information on this role and further detail on the job description, please reach out to me at 646-300-8349.

  • USA

    Accounting & finance

    $130000 - $165000 per annum
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    This is an excellent opportunity to join one of the most exciting Biopharmaceutical investment setups in the Greater New York City area with a robust pipeline of investigational products across a vast amount of different therapeutic areas.

    This is a rare chance to join a highly skilled team assessing acquisitions through their venture capitalist structure. The successful applicant will have the opportunity to take the lead from a broad payroll perspective for a small to mid-sized organization who are rapidly growing and increasing their headcount.

    As Director of Payroll, you will be responsible to manage the full payroll lifecycle operations including but limited to the preparation, distribution, processing, and reporting of employee payroll compensation. You will have the opportunity to also act as the equity administrator managing all operations associated with the employee equity compensation plans.

    You must have a minimum of a Bachelor’s Degree and a minimum of 8 years of overseeing payroll operations for large and/or growing organizations. You must also have experience working within equity administration. A CPP or CEP certification as well as a background within the pharmaceutical industry would be looked at favorably.

    The company is one of the most unique in the industry with a proven track record of success in the biopharmaceutical space. This is the right time to be joining this truly innovative team!

    If you are interested in more information on this role and further detail on the job description, please reach out to me at 646-300-8349.

  • USA

    Clinical Operations

    $200000 - $250000 per annum
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    This is an excellent opportunity to join one of the most exciting pharmaceutical companies truly making a difference within the post-surgical pain space in the Northern New Jersey area.

    As the Medical Director you will oversee all aspects of clinical studies from the study design through to the medical monitoring of the studies. With a growing product and the chance to work on multiple clinical trials in the near future, this offers a great opportunity for career progression.

    Reporting directly into the VP of Clinical Operations, the applicant will have a rare opportunity to work closely with the clinical operations team to ensure the clinical studies are moving in the right direction. In this role, you will be responsible for the design of clinical development plans, protocol development, and clinical trial synopses. You will also be responsible for the medical oversight guaranteeing that the clinical quality data is meeting study goals and timelines. Medical evaluation of assigned trials will be crucial for this role.

    You must have a minimum of an MD from an accredited university and a minimum of 5 years of clinical research experience in a pharmaceutical or biotech company within the US. A pain management background and a US-based MD would be looked at favorably.

    The company is one of the most unique in the industry with a proven track record of success in the pain management space. This is the right time to be joining this truly innovative team!

    If you are interested in more information on this role and further detail on the job description, please reach out to me at 646-300-8349.

  • Clinical research

    £22000 - £27000 per annum, benefits
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    A growing patient recruitment company is seeking an ambitious individual to join their growing and dynamic team. My client partners with a wide range of Pharmaceutical clients to oversee patient recruitment for a variety of clinical trials. They specifically work in Alzheimer’s and have shown to cut recruitment time and spend by over 50%.

    You will be responsible for reaching out to new prospective research in order to conduct studies. Ideally you would have worked in an outbound telephone role, reaching out to new prospective clients. You will also have the opportunity to work on complex studies whilst staying close to the projects and key decision makes.

    Responsibilities:

    • Telephone outreach to prospective research sites
    • Coordinating studies along with project team
    • Conducting face to face meetings

    Experience required:

    • BSc or MSc in scientific discipline OR Business / Marketing
    • Social media experience would be beneficial
    • Strong communications skills over the phone and F2F
    • Experience working in a telephone-based environment
    • Alzheimer’s a bonus or experience in other complex therapy areas
    • Knowledge of Plymouth and surrounding areas


    Please contact Troy Neenan on 02072206237 or click apply.

  • Clinical research

    $75000 - $90000 per annum
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    A Family owned CRO is seeking a motived, forward-thinking individual in clinical research for a permanent Clinical Research Associate II (CRA II) to work either remotely. This is an excellent opportunity for those interested in being a part of multiple exciting studies in a broad range of therapeutic areas and to join a company that genuinely values their employees.

    The CRA II will be responsible for conducting independent visits to monitor protocol and regulatory requirements, as well as ensuring the data is organized and prepared for submission to federal agencies, sponsors, or the client company. The CRA II will also work closely with on-site project managers, as well as data managers, to coordinate trial data and management, and will require strong communication skills. The CRA II will also be required to develop SOPs, train junior research staff, contribute intellectually to studies, and facilitate relationships between the parent client and study sites.

    Key Requirements

    • BA or BS in a life science related field
    • 2+ years of independent on-site monitoring experience
    • Experience with technical information required to understand and conduct clinical protocols

    Compensation

    • Permanent hire
    • Competitive salary and benefits available
    • Collaborative and energetic working environment

    To hear more about this fantastic opportunity, please call 646-300-8377 or apply directly.

  • Apply

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    This is an excellent opportunity to join one of the most exciting global Biotech’s in the Greater Boston area with a robust late stage pipeline in gene therapy offering rapid career progression.

    As the Associate Director of Process Development, you will initially take on an operationally focused role managing and overseeing all the manufacturing processes including upstream and downstream characterization. The successful applicant will have the chance to manage a small team and implement global processes throughout the US.

    Reporting directly into the VP of Global Pharmaceutical Development, the applicant will have a rare opportunity to work side by side and gain exposure to interfacing and liaising with different departmental heads of business lines. In this role, you will primarily be responsible for transferring company strategy and further developing and supporting validation and implementation of manufacturing processes for specified products. You will also be responsible for ensuring quality and compliance are in line with GLP and GMP regulations.

    You must have a minimum of a Master’s degree in a life science or engineering discipline and a minimum of 8 years of process development experience in a pharmaceutical or biotech setting. You must also have process development experience within biologics and vaccines and knowledge of CMC regulations. Hands on experience within upstream or downstream manufacturing as well as experience within regulatory filings is a plus.

    The company is one of the most unique in the industry with a proven track record of success both domestic and abroad in the gene therapy space. This is the right time to be joining this truly innovative team!

    If you are interested in more information on this role and further detail on the job description, please reach out to me at 646-300-8349

  • Medical Devices

    €110000 - €120000 per annum, +Bonus, Handy, Laptop, Auto, Aktienpaket
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    Unser Klient ist derzeit auf dem Markt eines der führenden Medizintechnik-Unternehmen. Ein Innovatives Produkt, dass die Lebensqualität der Patienten verbessert.

    Aus diesem Grund suchen wir für die Region Zürich und Ostschweiz einen Clinical Consultant (m/w/d).


    Auf was Sie sich freuen können:

    – Patientenbetreuung durch eine fachgerechte Ausbildung und Beratung des medizinischen Personals
    – Reportings von klinisch relevanten Daten und Dokumentationen von Ergebnisse
    – Enge zusammenarbeit mit unseren Teammitgliedern und Vetriebskollegen
    – Klinische Beratung, Durchführung von Trainings und Verwaltung von Schulungen für unsere neueen und bestehenden Kunden
    – Trainings und Klinische Demos: Unterstützung bei der Koordination von klinischen Demos vor Ort.

    Was Sie mitnehmen sollten:

    – Erfolgreich abgeschlossene klinische oder technische Ausbildung idealerweise Erfahrung im Herzkatheterlabor
    – Mehrjährige Berufserfahrung in der direkten Patientenbetreuung auf Intensiv-oder Pflegestation
    – Mindestens zwei Berufsjahre Erfahrung im Aussendienst (=Industrieunternehmen)
    – Ausgezeichnete Kommunikations- und Präsentationsfähigkeiten sowie Teamfähigkeit
    – Hervorragende Deutsch– und Englischkenntnisse in Wort und Schrift
    – 50% Reisebereitschaft innerhalb der vorgegebenen Region und Einsetzbereitschaft für Notfallsituationen

    Bei Interesse und offene Fragen steht Ihnen unsere Kollegin Jessica Demirtas zur Verfügung unter der Nummer: +41 43 508 73 11 oder unter: jessica.d.a4lgdx1gqjqt@SkillsAlliance.aptrack.co

    Bitte beachten Sie Gehaltsangaben in CHF.

  • Medical Devices

    €110000 - €120000 per annum, +Bonus, Handy, Laptop, Auto, Aktienpaket
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    Before applying for this position you need to submit your online CV. Click the button below to continue.


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    Unser Klient ist derzeit eines der führende Medizintechnik-Unternehmen auf dem Markt. Ein Innovatives Produkt, dass die Lebensqualität der Patienten verbessert.

    Aus diesem Grund suchen wir für die Region Zürich und Ostschweiz einen Clinical Consultant (m / w / d).


    Auf diese Weise können Sie sich freuen:

    – Patientenbetreuung durch eine fachgerechte Ausbildung und Beratung des medizinischen Personals
    – Reportings von verwendeten Daten und Dokumentationen von Ergebnissen
    – Enge zusammenarbeit mit unseren Teammitgliedern und Vetriebskollegen
    – Klinische Beratung, Durchführung von Schulungen und Schulungen für unsere neuen und diesbezüglichen Kunden
    – Trainings und Klinische Demos: Unterstützung bei der Koordination von Kranken Demos vor Ort.

    Was Sie mitnehmen sollten:

    – Erfolgreich abgeschlossene klinische oder technische Ausbildung idealerweise im Herzkatheterlabor
    – Mehrjährige Berufserfahrung in der direkten Patientenbetreuung in der Intensiv- oder Pflegestation
    – Mindestens zwei Berufsjahre im Aussendienst (= Industrieunternehmen)
    – Ausgezeichnete Kommunikations- und Präsentationsfähigkeiten sowie Teamfähigkeit
    – Hervorragende English– und Englischkenntnisse in Wort und Schrift
    – 50% Reisebereitschaft innerhalb der gültigen Region und Einsetzbereitschaft für Notfallsituationen Für Ihr

    Interesse steht Ihnen Jessica Demirt zur Verfügung unter der Nummer: +41 43 508 73 11 oder unter: jessica.d.a4lgdx1gqjr2@SkillsAlliance.aptrack.co

    Bitte beachten Sie Gehaltsangaben in CHF.

  • Medical Devices

    €110000 - €120000 per annum, +Bonus, Handy, Laptop, Auto, Aktienpaket
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    Job
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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.


    Share

    Unser Klient ist derzeit eines der führenden Medizintechnik-Unternehmen auf dem Markt. Ein Innovatives Produkt, dass die Lebensqualität der Patienten verbessert.

    Aus diesem Grund suchen wir für die Region Zürich und Ostschweiz einen Clinical Consultant (m/w/d).


    Auf was Sie sich freuen können:

    – Patientenbetreuung durch eine fachgerechte Ausbildung und Beratung des medizinischen Personals
    – Reportings von klinisch relevanten Daten und Dokumentationen von Ergebnisse
    – Enge zusammenarbeit mit unseren Teammitgliedern und Vetriebskollegen
    – Klinische Beratung, Durchführung von Trainings und Verwaltung von Schulungen für unsere neueen und bestehenden Kunden
    – Trainings und Klinische Demos: Unterstützung bei der Koordination von klinischen Demos vor Ort.

    Was Sie mitnehmen sollten:

    – Erfolgreich abgeschlossene klinische oder technische Ausbildung idealerweise Erfahrung im Herzkatheterlabor
    – Mehrjährige Berufserfahrung in der direkten Patientenbetreuung auf Intensiv-oder Pflegestation
    – Mindestens zwei Berufsjahre Erfahrung im Aussendienst (=Industrieunternehmen)
    – Ausgezeichnete Kommunikations- und Präsentationsfähigkeiten sowie Teamfähigkeit
    – Hervorragende Deutsch– und Englischkenntnisse in Wort und Schrift
    – 50% Reisebereitschaft innerhalb der vorgegebenen Region und Einsetzbereitschaft für Notfallsituationen

    Bei Interesse und offene Fragen steht Ihnen unsere Kollegin Jessica Demirtas zur Verfügung unter der Nummer: +41 43 508 73 11.

    Bitte beachten Sie Gehaltsangaben in CHF.

  • Clinical Operations

    £60000 - £75000 per annum, excellent package + equity
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    Before applying for this position you need to submit your online CV. Click the button below to continue.


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    A very exciting opportunity to join a fast growing Biotech. Permanent Clinical Study Manager or Senior Clinical Study Manager role based in Oxfordshire offering an excellent salary and package.

    This exciting and innovative Biotech company are at early stages with trials working in a range of disease areas in advanced therapies. They will be expanding and will offer great long-term prospects. The company are looking for an experienced Study Manager to join the team, this would be working on interesting early phase studies in Fibrosis.

    This is a full-time and permanent position. It is office-based in Oxfordshire with flexibility to work from home for the right candidate. They offer an excellent salary and package around GBP 60-75K depending on experience + bonus + equity + extensive benefits.

    Skills Alliance are the exclusive partner for this Senior Clinical Study Manager / Senior Clinical Trial Manager position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • Clinical Operations

    £60000 - £75000 per annum, excellent package + equity
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    A very exciting opportunity to join a fast growing Biotech. Permanent Clinical Study Manager or Senior Clinical Study Manager role based in Oxfordshire offering an excellent salary and package.

    This exciting and innovative Biotech company are at early stages with trials working in a range of disease areas in advanced therapies. They will be expanding and will offer great long-term prospects. The company are looking for an experienced Study Manager to join the team, this would be working on interesting early phase studies in Oncology.

    This is a full-time and permanent position. It is office-based in Oxfordshire with flexibility to work from home for the right candidate. They offer an excellent salary and package around GBP 60-75K depending on experience + bonus + extensive benefits.

    Skills Alliance are the exclusive partner for this Senior Clinical Study Manager / Senior Clinical Trial Manager position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • USA

    Clinical research

    $40000 - $50000 per annum
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    Our client is a Fast-Growing Medical Device Company, backed by a global parent company, with goals in reducing the time and cost of volunteer recruitment for clinical trials through a science-validated, 1st in-class, ground breaking online test for brain health. With 60,000 Assessments test done so far, they are garnering raving news media reviews all over the country. Now they are poised to help family caregivers better support loved. And to facilitate the development of the next generation of mental illness drugs.

    The Research Engagement Coordinator is part of the Cogniciti Engagement Team and reports to their Regional Manager and ultimately to the Director of Operations and Engagement. Their purpose is to assist Regional Engagement Specialists in promoting the services of Cogniciti (i.e. Brain Health Workshops, Brain Health Assessment, Smart Tracker, Brain Health Registry), and help older adults to gain early access to free memory evaluations through its research partnerships.

    This includes older adults who have or may be at risk of developing Mild Cognitive Impairment (MCI) or Prodromal Alzheimer’s disease. They will accomplish this by ensuring that accessible information is provided to the older adults that attend Cogniciti’s unique Brain Health Workshop. They will specifically focus on engaging older adults that potentially qualify for local research studies by establishing and maintaining relationships with them during the hand off process to clinical research sites.

    They will also help to increase community awareness of current brain health issues among older adults by providing them with instruction on accessing the resources available on the Cogniciti website in addition to assisting with organizing and facilitating Brain Health Workshops to engage identified target populations.

    Essential and Desirable Criteria

    Formal Education

    • Diploma or Bachelor’s Degree in Gerontology, Clinical Research, Social Work, Psychology, Social/Behavioral Science or a related discipline.

    Experience

    • Minimum of six months experience working in Clinical Research.

    • Demonstrated ability to effectively read and understand clinical trial protocols and communicate key study details to older adults with little to no understanding of clinical research.

    • Demonstrated ability to effectively explain the advantage of participating in clinical research to venerable populations and assist in enrolling them into appropriate clinical trials.

    • Demonstrated ability to develop, implement and evaluate patient recruitment plans.

    • Demonstrated ability to effectively work independently with little supervision and collaboratively as part of a team.

    • Exceptional ability to engage and communicate to groups of people, tailoring communication to suit a specific target group or age range.

    Demonstrated understanding of the challenges and experiences of older adults from diverse backgrounds.

    • Highly developed verbal and written communication skills.

    Tools/Equipment

    • Advanced computer skills including troubleshooting technical difficulties such as Wi-Fi hotspots and connectivity, cloud-based word processing, spreadsheets, CRM and database applications.

    Communications

    • Ability to effectively communicate with peers and management.

    • Ability to conduct business meetings with clients in a professional manner.

    Time Management

    • Excellent organizational and time management skills with the ability to prioritize and manage multiple and competing work tasks and deliver to agreed targets.

    Other Skills/Competencies

    • Valid Class E, G or G2 Driver’s License

    • Valid Passport

    • Ability to lift 50 pounds or less

    • GCP Certification

    • BLS Certification

  • Clinical research

    $75000 - $90000 per annum
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    Share

    A Family owned CRO is seeking a motived, forward-thinking individual in clinical research for a permanent Clinical Research Associate II (CRA II) to work either remotely. This is an excellent opportunity for those interested in being a part of multiple exciting studies in a broad range of therapeutic areas and to join a company that genuinely values their employees.

    The CRA II will be responsible for conducting independent visits to monitor protocol and regulatory requirements, as well as ensuring the data is organized and prepared for submission to federal agencies, sponsors, or the client company. The CRA II will also work closely with on-site project managers, as well as data managers, to coordinate trial data and management, and will require strong communication skills. The CRA II will also be required to develop SOPs, train junior research staff, contribute intellectually to studies, and facilitate relationships between the parent client and study sites.

    Key Requirements

    • BA or BS in a life science related field
    • 2+ years of independent on-site monitoring experience
    • Experience with technical information required to understand and conduct clinical protocols

    Compensation

    • Permanent hire
    • Competitive salary and benefits available
    • Collaborative and energetic working environment

    To hear more about this fantastic opportunity, please call 646-300-8377 or apply directly.

  • USA

    Clinical research

    $75000 - $90000 per annum
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    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    A Family owned CRO is seeking a motived, forward-thinking individual in clinical research for a permanent Clinical Research Associate II (CRA II) to work either remotely. This is an excellent opportunity for those interested in being a part of multiple exciting studies in a broad range of therapeutic areas and to join a company that genuinely values their employees.

    The CRA II will be responsible for conducting independent visits to monitor protocol and regulatory requirements, as well as ensuring the data is organized and prepared for submission to federal agencies, sponsors, or the client company. The CRA II will also work closely with on-site project managers, as well as data managers, to coordinate trial data and management, and will require strong communication skills. The CRA II will also be required to develop SOPs, train junior research staff, contribute intellectually to studies, and facilitate relationships between the parent client and study sites.

    Key Requirements

    • BA or BS in a life science related field
    • 2+ years of independent on-site monitoring experience
    • Experience with technical information required to understand and conduct clinical protocols

    Compensation

    • Permanent hire
    • Competitive salary and benefits available
    • Collaborative and energetic working environment

    To hear more about this fantastic opportunity, please call 646-300-8377 or apply directly.

  • Clinical Operations

    £55000 - £65000 per annum, bonus + benefits
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    A very rare opportunity for an experienced (Senior) Study Manager or (Senior) Trial Manager to join an exciting niche start-up Biopharma, this position is permanent and office-based in London.

    This position is with a small and niche Biotech and will offer very exciting long-term prospects. This is quite a unique opportunity to join the company at early stages so there will be a lot of exposure. They work in exciting and innovative therapy areas.

    The Senior Clinical Trial Manager role is a great opportunity for Study Manager to work in a wide ranging study management role, including program oversight, line management and working on a cross-functional basis. They require a strong project management management experience from Pharma or CRO. This would be working on early phase trials.

    This is a permanent and full-time position. It is office-based in London offering around GBP 55-65K depending on experience + bonus + benefits.

    Skills Alliance are the preferred supplier for this role, please contact Mark Anderson for more details – +44 207 220 6209 or click APPLY NOW!

  • Clinical Operations

    £55000 - £70000 per annum, excellent package
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    A very exciting opportunity to join a fast growing Biotech. Permanent Clinical Study Manager or Senior Clinical Study Manager role based in London offering an excellent salary and package.

    This exciting and innovative Biotech company are at early stages with trials working in advanced therapies. They will be expanding and will offer great long-term prospects. The company are looking for an experienced Study Manager to join the team, this would be working on interesting early phase studies.

    This is a full-time and permanent position. It is office-based in London with flexibility to work from home. They offer an excellent salary and package around GBP 55-75K depending on experience + bonus + extensive benefits.

    Skills Alliance are the preferred supplier for this Senior Clinical Study Manager / Senior Clinical Trial Manager position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

    Key words: Clinical Study Manager / Clinical Trial Manager / Global Study Manager / Senior Study Manager / Senior Clinical Study Manager / Pharma / Biopharma / Biotech / Berkshire / London / Hertfordshire / Buckinghamshire / England / UK / permanent / Surrey / advanced therapies / gene therapy / cell therapy / ATMP

  • Clinical research

    £65000 - £75000 per annum, excellent package
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    A very exciting opportunity to join a fast growing Biotech. Permanent Clinical Project Manager or Senior Clinical Project Manager role based in Hertfordshire offering an excellent salary and package.

    This exciting and innovative Biotech company are at early stages with trials working in advanced therapies. They will be expanding and will offer great long-term prospects. The company are looking for an experienced Senior Study Manager, this would be working on interesting early phase studies. They require a strong clinical trial management background, ideally experience in early phase, complex TAs and ideally program level experience. It would be overseeing one of their two programs.

    This is a full-time and permanent position. It is office-based in Hertfordshire with flexibility to work from home. They offer an excellent salary and package around GBP 65-70K depending on experience + bonus + extensive benefits.

    Skills Alliance are the preferred supplier for this CPM / Senior CPM position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • Clinical Operations

    £60000 - £70000 per annum, excellent package
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    A very exciting opportunity to join a fast growing Biotech. Permanent Clinical Project Manager role based in Hertfordshire offering an excellent salary and package.

    This exciting and innovative Biotech company are at early stages with trials working in advanced therapies. They will be expanding and will offer great long-term prospects. The company are looking for an experienced Study Manager, this would be working on interesting early phase studies. They require a strong clinical trial management background, ideally experience in early phase, complex TAs and overseeing CROs and vendors.

    This is a full-time and permanent position. It is office-based in Hertfordshire with flexibility to work from home. They offer an excellent salary and package around GBP 60-70K depending on experience + bonus + extensive benefits.

    Skills Alliance are the preferred supplier for this CPM position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • Medical communications

    £45000 - £55000 per annum, Pension, Sabbatical, Private Medical, etc
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    Skills Alliance have been retained by an award winning, independent and creative medical communications agency who are on the lookout for a passionate Account Director to join their team in Central London.

    This is an opportunity to join a dynamic team who possess a passion for communicating science via innovative multi- channel programs. With a strong focus on Rare Diseases, this medical communications agency have a broad client list to include Global Pharmaceutical companies, Med- Device Companies and Start- Up Biotech’s.

    Having recently promoted their current team, this agency is seeking a highly experienced and ambitious Senior Account Manager who is looking to take that step up in role or an Account Director who is looking for more transparency in role within a close- knit and well- respected creative med comms agency.

    This agency offers a competitive salary and benefits structure which rivals its international competitors whilst offering a bespoke personal development program.

    To find out further information, please Click Apply and submit an up- to – date copy of your CV.

    The person must have the right to work in the U.K.

  • Medical Devices

    £80000 - £90000 per annum, benefits
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    An innovative Medical Device company is seeking an experience Director of Clinical Affairs who is keen to move into a dynamic organisation and be part of the Executive team.

    They are currently looking for a strong cross functional manager who has experience in leading studies from inception through to product approval. This is a rare opportunity for someone keen to move into a hands-on environment and looking to shape the Clinical department moving forward.

    Responsibilities:

    • Lead the global clinical strategy whilst managing cross functional departments
    • Line manage a small team of CRAs and PMs
    • Working closely with KOL’s

    Experience required:

    • At least 5-10 years study management experience
    • Experience working at executive level
    • Degree level educated with strong preference for PhD relevant discipline

    For more info please contact Troy Neenan or click apply.

  • Clinical research

    £30000 - £35000 per annum, benefits
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    I am partnered with a growing Pharmaceutical Services Company who are seeking a Clinical Trial Associate to join their experienced team. This company specialises in working with SME Biotech’s and Pharma companies on complex studies, this is a unique opportunity to work with the Leadership team whilst taking on a wide range of responsibilities.

    You will be responsible for supporting the project team on a variety of studies, designating communication and overseeing study documentation. You will also be responsible for managing the TMF/e-TMF and any other ad hoc activities.

    Responsibilities:

    • TMF management
    • Supporting the project team
    • Oversee all administrative tasks

    Experience:

    • 3 years + clinical trial administration experience
    • Experience in managing electronic systems
    • Proactive/strong communication skills

    For more information please contact Troy Neenan on 02072206237.

  • Apply

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    The position stewards procurement responsibilities through product qualification steps and through the eventual hand-off to the production team as a fully qualified product. This role manages and monitors the costs throughout the development cycle and provides report outs to the team and management.

    The ideal experience they would be looking for from the succesful candidate would be:

    • o 3 – 5 years in a Procurement role
    • o Work experience in medical device, or similar regulated industry (e.g. Pharmaceutical, Biologics) desirable.
    • o Demonstrated ability to support multiple, complex projects via participation on several cross-functional teams.
    • o Knowledge of e-sourcing systems including SAP Finance suite and Ariba or comparable systems’ experience required.

    This is a full time contract role for a minimum of 3 months which could require UK wide travel.

    If this looks like something you are interested in pleae apply now as interviews can be organised ASAP.

  • QA Manufacturing

    €160000 - €200000 per annum, 20% Bonus + Equity + Health Insurance + Sport Contribution
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    In collaboration with a global biotechnology company, Skills Alliance is currently recruiting for a Director of QA. As DQA, you will be responsible for all QA activities from the design to operational phases of the new facility. You will work with contractors and define a strategy for approval of qualification/validation and engineering documents, you will be the main contact point for quality compliance topics and be responsible for regulatory inspections.

    To qualify for this position, you must speak English and French. You must have a minimum of 10 years in senior quality management positions in biopharmaceutical environments. Knowledge and demonstrated knowledge of biotech processes, utilities and technology in a GMP environment is necessary. You will need to demonstrate the ability to be result oriented and an excellent team leader. A bachelor’s degree in engineering, bioprocesses or a life science topic is necessary. You must have the right to live and work in Switzerland to be considered.

    If this position is of interest to you or your peers, please contact Khephren Mongongu +41 43 508 29 16 to discuss this in more detail or apply directly. All applications and discussion are treated confidentially.

  • Clinical research

    £30000 - £35000 per annum, benefits
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    I am partnered with a growing Pharmaceutical Services Company who are seeking a Clinical Trial Associate to join their experienced team. This company specialises in working with SME Biotech’s and Pharma companies on complex studies, this is a unique opportunity to work with the Leadership team whilst taking on a wide range of responsibilities.

    You will be responsible for supporting the project team on a variety of studies, designating communication and overseeing study documentation. You will also be responsible for managing the TMF/e-TMF and any other ad hoc activities.

    Responsibilities:

    • TMF management
    • Supporting the project team
    • Oversee all administrative tasks

    Experience:

    • 3 years + clinical trial administration experience
    • Experience in managing electronic systems
    • Proactive/strong communication skills

    For more information please contact Troy Neenan on 02072206237.

  • Medical affairs

    £70000 - £80000 per annum, company car + bonus
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    MSL UK – Nationwide role with a start-up pharmaceutical company

    I am currently working with a client of mine who is a US Start-up pharmaceutical company looking to now establish their European footprint.

    With a product launch due in EU, they are looking for an MSL to join their team in the UK. You will be taking on a nationwide role, offering you great autonomy as part of the role. This position is also a highly visible role as you’ll be joining a growing company, so there is lots of opportunity to progress your career within the business.

    My client are already running advisory boards across Europe, so they are looking for someone to start as soon as possible with the interview process taking place over the next couple of weeks.

    You’ll be working on a product within the haematology therapeutic area, but pevious experience in this field is not essential. You must have extensive MSL experience, and you must be happy to travel across the UK as part of this role.

    My client will consider someone based anywhere in the UK provided you have easy accessibility to travelling across the country.

    This is a great opportunity to join a start-up company at an exciting time with lots of potential for you to grow and develop your career alongside the companies growth.

    For more information about this opportunity or any similar opportunities, please contact Chanel Hicken on 0207 220 6206. Alternatively, please email your CV to chanel.h.a4lgdx1gqmsj@skillsalliance.aptrack.co and we can arrange a time to speak.

  • UK

    HR and talent acquisition

    Competitive
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    A global Pharmaceuticals company in Surrey is seeking an experienced Reward Specialist to lead the execution of their reward strategy across the EMEA region.

    This is an exciting opportunity for an experienced Senior Reward Specialist to lead business as usual and project-based reward activities.

    Responsibilities:

    • Develop approach to benchmarking and salary surveys
    • Provide insights and analysis to the EMEA reward team using surveys, executive compensation, bonus and LTiP analysis
    • Development of reward, recognition and benefit policies and processes, ensuring local alignment to EMEA reward strategy
    • Produce recommendations on pay range increases, pay movement forecasts and cost analysis
    • Support effective delivery of reward cycles
    • Build and maintain intranet content for Reward policies and processes
    • Regular reporting, insights and analysis

    Requirements:

    • Extensive experience in reward analysis; surveys, benchmarking and pay reviews
    • Advanced Excel skills
    • Experienced working within an international environment
    • 5+ years’ experience as a Reward Specialist

    Why Apply?

    • Reputable Pharmaceuticals company offering a great culture
    • Flexible working
    • Competitive rate of pay

    Please contact Sarah Brambill from Skills Alliance for more information or to submit an application.

  • UK

    HR and talent acquisition

    Competitive
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    A start-up Biotechnology company are seeking a dynamic HR Business Partner to work closely with their chief commercial officer and lead projects around talent management, restructuring and employee engagement, alongside business as usual business partnering activities.

    The Human Resources Business Partner will be responsible for a mixture of strategic and operational activities and will have the opportunity to support this speciality life sciences company through a period of growth.

    This is a 6-month assignment to begin with, but there is definite opportunities for contract extension or to become a permanent employee in the future.

    Responsibilities include:

    • Identify and analyse the HR needs of the teams your support
    • Work with stakeholders throughout the strategic planning process and on the development of HR strategies to support their needs
    • Drive Human Resources initiatives within the organisation
    • Offer technical human resources support to line managers in areas such as change management, organisational transformation, resourcing, compensation, benefits, people development and employee relations
    • Lead talent acquisition activities for key hires within the business

    Requirements:

    • CIPD level 7 qualified or similar
    • 5+ years’ experience within Human Resources
    • Experienced working within the Life Sciences industry, and within a start-up environment
    • Approachable, versatile, adaptable and dynamic

    Please contact Sarah Brambill from Skills Alliance to make an application or for more information.

  • USA

    Manufacturing

    $140000 - $150000 per annum
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    This is an excellent opportunity to join one of the most exciting global Biotech’s in the Greater Boston area with a robust late stage pipeline in gene therapy offering rapid career progression.

    As the Associate Director of Process Development, you will initially take on an operationally focused role managing and overseeing all the manufacturing processes including upstream and downstream characterization. The successful applicant will have the chance to manage a small team and implement global processes throughout the US.

    Reporting directly into the VP of Global Pharmaceutical Development, the applicant will have a rare opportunity to work side by side and gain exposure to interfacing and liaising with different departmental heads of business lines. In this role, you will primarily be responsible for transferring company strategy and further developing and supporting validation and implementation of manufacturing processes for specified products. You will also be responsible for ensuring quality and compliance are in line with GLP and GMP regulations.

    You must have a minimum of a Master’s degree in a life science or engineering discipline and a minimum of 8 years of process development experience in a pharmaceutical or biotech setting. You must also have process development experience within biologics and vaccines and knowledge of CMC regulations. Hands on experience within upstream or downstream manufacturing as well as experience within regulatory filings is a plus.

    The company is one of the most unique in the industry with a proven track record of success both domestic and abroad in the gene therapy space. This is the right time to be joining this truly innovative team!

    If you are interested in more information on this role and further detail on the job description, please reach out to me at 646-300-8349.

  • USA

    Clinical Operations

    $200000 - $250000 per annum
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    This is an excellent opportunity to join one of the most exciting pharmaceutical companies truly making a difference within the post-surgical pain space in the Northern New Jersey area.

    As the Medical Director, you will oversee all aspects of clinical studies from the study design through to the medical monitoring of the studies. With a growing product and the chance to work on and oversee multiple clinical trials in the near future, this offers a great opportunity for career progression.

    Reporting directly into the VP of Clinical Operations, the applicant will have a rare opportunity to work closely with the clinical operations team to ensure the clinical studies are moving in the right direction. In this role, you will be responsible for the design of clinical development plans, protocol development, and clinical trial synopses. You will also be responsible for the medical oversight guaranteeing that the clinical quality data is meeting study goals and timelines. Medical evaluation of assigned trials will be crucial for this role.

    You must have a minimum of an MD from an accredited university and a minimum of 5 years of clinical research experience in a pharmaceutical or biotech company within the US. A pain management background and a US-based MD would be looked at favorably.

    The company is one of the most unique in the industry with a proven track record of success in the pain management space. This is the right time to be joining this truly innovative team!

    If you are interested in more information on this role and further detail on the job description, please reach out to me at 646-300-8349.

  • USA

    Pharmacovigilance

    $115000 - $125000 per annum
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    This is an excellent opportunity to join a dynamic global specialty pharmaceutical company that are exponentially growing their team within the Greater Philadelphia area.

    As the Drug Safety Manager, you will be primarily responsible for the management of Individual Case Safety Report processing for branded and generic products. The successful applicant will have the exciting opportunity to manage a small team of Drug Safety Associates to ensure case processing activities are being executed properly.

    In this role, you will be responsible for guaranteeing safety reporting and case processing are accurately meeting regulatory guidelines and company processes by managing team day to day operations. You will also be responsible for assisting in the development of safety processes and case processing guidelines. Monitoring case processing workflow and adverse event information to input into the safety database will be an important aspect to this role as well.

    You must have a Bachelor’s Degree in a life sciences discipline and a minimum of 8 years of Pharmacovigilance and/or Drug Safety experience in a pharmaceutical setting. Having an advanced degree as well as past management experience would be looked at extremely favorably.

    The company is one of the most unique in the industry with a proven track record of success in the branded and generic pharmaceutical space both domestic and abroad. With recent successful Phase 3 results, this is the right time to be joining this truly innovative team!

    If you are interested in more information on this role and further detail on the job description, please reach out to me at 646-300-8349.

  • Apply

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    I am urgently seeking Medical Writers, specialized in regulatory submissions in the BioPharmaceutical Industry for an opportunity working with a company that values a diverse and supportive environment for their employees, while continuing to deliver new innovative therapies to the market that will help improve the lives of individuals with cancer. Must live in Boston or surrounding area or be willing to relocate to Boston, Massachusetts, as this is a permanent, Full-Time position requiring on-site work.

    Reporting into the VP of Medical Writing, the essential functions of the role include but are not limited to preparing, editing and review of IND’s, NDA’s, CSR’s, protocols, consent forms, IB’s, SOP’s, document support, and quality review.

    Ideal Candidate must have at least 5 years of Medical Writing experience, Regulatory Submissions experience (IND, NDA, etc), and Biotech or Pharmaceutical Industry experience as a Medical Writer.

  • USA

    Manufacturing

    $70000 - $100000 per annum
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    Clinical manufacturing site transitioning to commercial, expanding shift patents and this is a great time for an Upstream Supervisor to join with a rapidly growing organization.

    I am urgently seeking Manufacturing Professionals, specialized in Upstream Operations, who would be interested in a leadership role as an Upstream Manufacturing Supervisor. This is a great opportunity offering career progression and permanent position with a leading, growing BioPharma company in New Jersey.

    Reporting into the Upstream Senior Manager the essential functions of the role will include meeting timelines, overseeing/mentoring a team of direct reports and Upstream Operations, SOPs, MBRs, Protocols, and other documentation.

    Ideal candidate must have previous leadership/supervisory experience and at least 5 years of Upstream, Aseptic, Biologics experience in the BioPharma industry.

  • Clinical research

    £30000 - £35000 per annum, benefits
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    I am partnered with a growing Pharmaceutical Services Company who are seeking a Clinical Trial Associate to join their experienced team. This company specialises in working with SME Biotech’s and Pharma companies on complex studies, this is a unique opportunity to work with the Leadership team whilst taking on a wide range of responsibilities.

    You will be responsible for supporting the project team on a variety of studies, designating communication and overseeing study documentation. You will also be responsible for managing the TMF/e-TMF and any other ad hoc activities.

    Responsibilities:

    • TMF management
    • Supporting the project team
    • Oversee all administrative tasks

    Experience:

    • 3 years + clinical trial administration experience
    • Experience in managing electronic systems
    • Proactive/strong communication skills

    For more information please contact Troy Neenan on 02072206237.

  • Medical Devices

    £80000 - £90000 per annum, benefits
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    Share

    An innovative Medical Device company is seeking an experience Director of Clinical Affairs who is keen to move into a dynamic organisation and be part of the Executive team.

    They are currently looking for a strong cross functional manager who has experience in leading studies from inception through to product approval. This is a rare opportunity for someone keen to move into a hands-on environment and looking to shape the Clinical department moving forward.

    Responsibilities:

    • Lead the global clinical strategy whilst managing cross functional departments
    • Line manage a small team of CRAs and PMs
    • Working closely with KOL’s

    Experience required:

    • At least 5-10 years study management experience
    • Experience working at executive level
    • Degree level educated with strong preference for PhD relevant discipline

    For more info please contact Troy Neenan or click apply.