Jazz Pharmaceuticals
Cambridge, Cambridgeshire
If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit for more information. Brief Description The Business & Technology Capabilities (B&TC) Sr. Analyst works closely with B&TC and GCDO colleagues, in collaboration with Information Services (IS) to support cross functional clinical study teams regarding the implementation and management of digital systems/technology used by GCDO including but not limited to Veeva Clinical Vault. The B&TC Sr. Analyst demonstrates a good understanding of Veeva Clinical Vault functionality. The B&TC Sr. Analyst works with the 'Performance and Training' function to facilitate the collation, visualization, analysis & storage of relevant metrics for GCDO to ensure optimal trial performance and aid continuous improvement Essential Functions/Responsibilities Establishes and maintains, digital systems on behalf of GCDO primarily the Veeva Clinical Vault applications eTMF, CTMS, SSU and Site Connect, plus other Clinical Systems as required Carry out required activities in JV eTMF for all Clinical Vault/eTMF user access requests in accordance with the documented process Carry out required system maintenance in JV eTMF to ensure end users can perform their role in accordance with the documented process Works closely with Business owners and system owners of digital system including but not limited to Veeva Clinical Vault, to ensure GCDO teams are trained appropriately in the functionality of relevant digital systems Collaborates with other functional areas/departments and key stakeholders to maximize the utilization of the digital systems (e.g. creating dashboards, reports, ensuring best use of all Clinical Vault functionality Collaborates with partner vendors, as needed, in relation to system knowledge sharing and utilization Collaborates with subject matter experts on development of relevant digital system training materials, QMS documentation, and Validation activities and documentation Maintains a sound familiarity with Jazz's systems and related processes Establishes and maintains, digital systems on behalf of GCDO primarily the Veeva Clinical Vault applications eTMF, CTMS, SSU and Site Connect, plus other Clinical Systems as required Carry out required activities in JV eTMF for all Clinical Vault/eTMF user access requests in accordance with the documented process Carry out required system maintenance in JV eTMF to ensure end users can perform their role in accordance with the documented process Works closely with Business owners and system owners of digital system including but not limited to Veeva Clinical Vault, to ensure GCDO teams are trained appropriately in the functionality of relevant digital systems Collaborates with other functional areas/departments and key stakeholders to maximize the utilization of the digital systems (e.g. creating dashboards, reports, ensuring best use of all Clinical Vault functionality Collaborates with partner vendors, as needed, in relation to system knowledge sharing and utilization Collaborates with subject matter experts on development of relevant digital system training materials, QMS documentation, and Validation activities and documentation Maintains a sound familiarity with Jazz's systems and related processes Identifies improvement opportunities related to digital systems, and assists with developing enhancement plans and roadmaps Organizes and delivers relevant specialist training sessions and workshops with a key focus on digital systems Required Knowledge, Skills, and Abilities IT-literate and passionate/experienced towards new technology and digital systems including, but not limited to Microsoft-based applications and Veeva Clinical Vault applications CTMS, eTMF, SSU and Site Connect An experienced clinical trials professional who is well versed in the field of clinical study management activities, combined with excellent project management, training & mentoring capabilities Previous experience working in Veeva Clinical Vault as an end user, business, or system administrator Ability to effectively interface with CROs and software vendor Previous experience working in clinical trials, with emphasis on GxP and compliance Has a sound working knowledge of clinical operations, clinical processes, Trial Master File regulations medical terminology, global CROs and vendor management Excellent interpersonal and communication skills, both written and verbal Good time management and organizational skills Quality driven with a focus on attention to detail Ability to work independently and take initiative Flexible approach with respect to work assignments and new learning Ability to prioritize workload and manage multiple and varied tasks with enthusiasm Ability to work effectively in a matrix environment and to demonstrate, and foster, teamwork within the group, as well as across the organization Required/Preferred Education and Licenses A minimum of a BA/BS, preferably in the scientific/healthcare and/or technology field A minimum of 5 years of experience in clinical related technology for the pharmaceutical/biotechnology industry Knowledge of FDA/ICH guidelines and industry standard practices regarding the management of clinical trial data and studies. Working knowledge of FDA Guidance Documents: Computerized Systems Used in Clinical Trials, General Principles of Software Validation. Working knowledge of 21 C.F.R. Part 11 Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. FOR US BASED CANDIDATES ONLY Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $100,000.00 - $150,000.00 Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis. At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: .
If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit for more information. Brief Description The Business & Technology Capabilities (B&TC) Sr. Analyst works closely with B&TC and GCDO colleagues, in collaboration with Information Services (IS) to support cross functional clinical study teams regarding the implementation and management of digital systems/technology used by GCDO including but not limited to Veeva Clinical Vault. The B&TC Sr. Analyst demonstrates a good understanding of Veeva Clinical Vault functionality. The B&TC Sr. Analyst works with the 'Performance and Training' function to facilitate the collation, visualization, analysis & storage of relevant metrics for GCDO to ensure optimal trial performance and aid continuous improvement Essential Functions/Responsibilities Establishes and maintains, digital systems on behalf of GCDO primarily the Veeva Clinical Vault applications eTMF, CTMS, SSU and Site Connect, plus other Clinical Systems as required Carry out required activities in JV eTMF for all Clinical Vault/eTMF user access requests in accordance with the documented process Carry out required system maintenance in JV eTMF to ensure end users can perform their role in accordance with the documented process Works closely with Business owners and system owners of digital system including but not limited to Veeva Clinical Vault, to ensure GCDO teams are trained appropriately in the functionality of relevant digital systems Collaborates with other functional areas/departments and key stakeholders to maximize the utilization of the digital systems (e.g. creating dashboards, reports, ensuring best use of all Clinical Vault functionality Collaborates with partner vendors, as needed, in relation to system knowledge sharing and utilization Collaborates with subject matter experts on development of relevant digital system training materials, QMS documentation, and Validation activities and documentation Maintains a sound familiarity with Jazz's systems and related processes Establishes and maintains, digital systems on behalf of GCDO primarily the Veeva Clinical Vault applications eTMF, CTMS, SSU and Site Connect, plus other Clinical Systems as required Carry out required activities in JV eTMF for all Clinical Vault/eTMF user access requests in accordance with the documented process Carry out required system maintenance in JV eTMF to ensure end users can perform their role in accordance with the documented process Works closely with Business owners and system owners of digital system including but not limited to Veeva Clinical Vault, to ensure GCDO teams are trained appropriately in the functionality of relevant digital systems Collaborates with other functional areas/departments and key stakeholders to maximize the utilization of the digital systems (e.g. creating dashboards, reports, ensuring best use of all Clinical Vault functionality Collaborates with partner vendors, as needed, in relation to system knowledge sharing and utilization Collaborates with subject matter experts on development of relevant digital system training materials, QMS documentation, and Validation activities and documentation Maintains a sound familiarity with Jazz's systems and related processes Identifies improvement opportunities related to digital systems, and assists with developing enhancement plans and roadmaps Organizes and delivers relevant specialist training sessions and workshops with a key focus on digital systems Required Knowledge, Skills, and Abilities IT-literate and passionate/experienced towards new technology and digital systems including, but not limited to Microsoft-based applications and Veeva Clinical Vault applications CTMS, eTMF, SSU and Site Connect An experienced clinical trials professional who is well versed in the field of clinical study management activities, combined with excellent project management, training & mentoring capabilities Previous experience working in Veeva Clinical Vault as an end user, business, or system administrator Ability to effectively interface with CROs and software vendor Previous experience working in clinical trials, with emphasis on GxP and compliance Has a sound working knowledge of clinical operations, clinical processes, Trial Master File regulations medical terminology, global CROs and vendor management Excellent interpersonal and communication skills, both written and verbal Good time management and organizational skills Quality driven with a focus on attention to detail Ability to work independently and take initiative Flexible approach with respect to work assignments and new learning Ability to prioritize workload and manage multiple and varied tasks with enthusiasm Ability to work effectively in a matrix environment and to demonstrate, and foster, teamwork within the group, as well as across the organization Required/Preferred Education and Licenses A minimum of a BA/BS, preferably in the scientific/healthcare and/or technology field A minimum of 5 years of experience in clinical related technology for the pharmaceutical/biotechnology industry Knowledge of FDA/ICH guidelines and industry standard practices regarding the management of clinical trial data and studies. Working knowledge of FDA Guidance Documents: Computerized Systems Used in Clinical Trials, General Principles of Software Validation. Working knowledge of 21 C.F.R. Part 11 Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. FOR US BASED CANDIDATES ONLY Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $100,000.00 - $150,000.00 Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis. At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: .
Whitehall Resources Ltd
Gaydon, Warwickshire
SOC Manager Whitehall Resources are looking for a SOC Manager. This role is hybrid working with 2-3 days per week onsite in Warwickshire, and the remainder remote working, for an initial 6-month contract. *Inside IR35* Job Description: Establish goals and priorities by working closely with your team to identify the most critical focus areas. These include: Improving incident response times Reducing false positives and other extraneous alerts Enhancing threat detection capabilities Oversee your staff's activities and ensure they focus on the right priorities Oversee SOC activities by reviewing your team's performance metrics, incident reports and other key indicators Lead incident response efforts when a security incident occurs, the SOC team has to respond as quickly as possible Lead these efforts by establishing clear incident response procedures and protocols and conveying them to the team Analyse incident reports to understand your organization's security posture by reviewing incident reports, SOC managers identify patterns and trends that may indicate weaknesses or vulnerabilities in their security defences Serve as the point of contact (POC) for security incidents within the company. You are the primary liaison between the SOC team, other internal stakeholders, and external parties such as vendors, clients or regulatory bodies. Be responsible for conducting information security investigations as a result of security incidents. These are previously identified by the Level 2 security analyst who are monitoring the security consoles from various SOC entry channels (SIEM, Tickets, Email and Phone) End to end security incident management. You will play a key role in providing the highest level of technical expertise and handling the most complex security incidents. Report to the Customer about security operations. This means that you must keep the CISO and Head of security operations informed about everything that's happening in the operations centre. You can do this by preparing clear and concise reports that highlight key findings, and recommendations about the operations. Your reports will help the customer make informed decisions about security investments and strategies that align with the company's goals. Your responsibilities: Manage service and process improvements of SOC, auditing SOC incidents, identifying new use cases and automations POC for SOC engineering team, threat intelligence analyst and Threat exposure management Act as a point of escalation for Level-2 SOC security analysts in support of information security investigations to provide guidance and oversight on incident resolution and containment techniques Act as the lead coordinator to individual information security incidents Mentor security analysts regarding risk management, information security controls, incident analysis, incident response, SIEM monitoring, and other operational tasks (tools, techniques, Procedures) in support of technologies managed by the Security Operations Centre. Document incidents from initial detection through final resolution Ensure threat management, threat modelling, identify threat vectors and develop use cases for security monitoring Create reports, dashboards, metrics for SOC operations and presentation to Sr. Mgmt. Act as focal point for any investigations involving security; to prepare reports and note follow up action Participate in the role of Incident Manager during any incidents and emergencies Ensure that all business recovery/contingency plans and/or procedures held within the security control rooms are always kept up to date Coordinate with IT teams on escalations, tracking, performance issues, and outages Essential skills and experience: Strong knowledge in Authentication, End Point Security, Internet Policy Enforcement, Firewalls, Web Content Filtering, Database Activity Monitoring (DAM), Public Key Infrastructure (PKI), Data Loss Prevention (DLP), Identity and Access Management (IAM) and SOC advancements such as EDR and SOAR Good knowledge of SIEM technologies, like Google Chronicle, Splunk ES or QRadar In-depth familiarity with security policies based on industry standards and best practices Experienced within the information security field, with emphasis on security operations, incident management, intrusion analysis, security device installations, configuration, and troubleshooting (e. g., Firewall, IDS, etc.) Experience in Log source integration and in Developing new correlation rules & Parser writing Experienced in SOC automation development, cloud operations (e. g. AWS), Designing, building security operations centers and Regulatory Compliance Ability to lead and communicate efficiently within a team environment along with Incident management process development and/or incident management experience Solid understanding of information technology and information security required Excellent communication and presentation skills with demonstrated skill in presenting analytical data effectively to varied audiences (including executives) Ability to work well under pressure with differing levels of Management Desirable skills and experience: Experience of Agile ways of working. All of our opportunities require that applicants are eligible to work in the specified country/location, unless otherwise stated in the job description. Whitehall Resources are an equal opportunities employer who value a diverse and inclusive working environment. All qualified applicants will receive consideration for employment without regard to race, religion, gender identity or expression, sexual orientation, national origin, pregnancy, disability, age, veteran status, or other characteristics.
SOC Manager Whitehall Resources are looking for a SOC Manager. This role is hybrid working with 2-3 days per week onsite in Warwickshire, and the remainder remote working, for an initial 6-month contract. *Inside IR35* Job Description: Establish goals and priorities by working closely with your team to identify the most critical focus areas. These include: Improving incident response times Reducing false positives and other extraneous alerts Enhancing threat detection capabilities Oversee your staff's activities and ensure they focus on the right priorities Oversee SOC activities by reviewing your team's performance metrics, incident reports and other key indicators Lead incident response efforts when a security incident occurs, the SOC team has to respond as quickly as possible Lead these efforts by establishing clear incident response procedures and protocols and conveying them to the team Analyse incident reports to understand your organization's security posture by reviewing incident reports, SOC managers identify patterns and trends that may indicate weaknesses or vulnerabilities in their security defences Serve as the point of contact (POC) for security incidents within the company. You are the primary liaison between the SOC team, other internal stakeholders, and external parties such as vendors, clients or regulatory bodies. Be responsible for conducting information security investigations as a result of security incidents. These are previously identified by the Level 2 security analyst who are monitoring the security consoles from various SOC entry channels (SIEM, Tickets, Email and Phone) End to end security incident management. You will play a key role in providing the highest level of technical expertise and handling the most complex security incidents. Report to the Customer about security operations. This means that you must keep the CISO and Head of security operations informed about everything that's happening in the operations centre. You can do this by preparing clear and concise reports that highlight key findings, and recommendations about the operations. Your reports will help the customer make informed decisions about security investments and strategies that align with the company's goals. Your responsibilities: Manage service and process improvements of SOC, auditing SOC incidents, identifying new use cases and automations POC for SOC engineering team, threat intelligence analyst and Threat exposure management Act as a point of escalation for Level-2 SOC security analysts in support of information security investigations to provide guidance and oversight on incident resolution and containment techniques Act as the lead coordinator to individual information security incidents Mentor security analysts regarding risk management, information security controls, incident analysis, incident response, SIEM monitoring, and other operational tasks (tools, techniques, Procedures) in support of technologies managed by the Security Operations Centre. Document incidents from initial detection through final resolution Ensure threat management, threat modelling, identify threat vectors and develop use cases for security monitoring Create reports, dashboards, metrics for SOC operations and presentation to Sr. Mgmt. Act as focal point for any investigations involving security; to prepare reports and note follow up action Participate in the role of Incident Manager during any incidents and emergencies Ensure that all business recovery/contingency plans and/or procedures held within the security control rooms are always kept up to date Coordinate with IT teams on escalations, tracking, performance issues, and outages Essential skills and experience: Strong knowledge in Authentication, End Point Security, Internet Policy Enforcement, Firewalls, Web Content Filtering, Database Activity Monitoring (DAM), Public Key Infrastructure (PKI), Data Loss Prevention (DLP), Identity and Access Management (IAM) and SOC advancements such as EDR and SOAR Good knowledge of SIEM technologies, like Google Chronicle, Splunk ES or QRadar In-depth familiarity with security policies based on industry standards and best practices Experienced within the information security field, with emphasis on security operations, incident management, intrusion analysis, security device installations, configuration, and troubleshooting (e. g., Firewall, IDS, etc.) Experience in Log source integration and in Developing new correlation rules & Parser writing Experienced in SOC automation development, cloud operations (e. g. AWS), Designing, building security operations centers and Regulatory Compliance Ability to lead and communicate efficiently within a team environment along with Incident management process development and/or incident management experience Solid understanding of information technology and information security required Excellent communication and presentation skills with demonstrated skill in presenting analytical data effectively to varied audiences (including executives) Ability to work well under pressure with differing levels of Management Desirable skills and experience: Experience of Agile ways of working. All of our opportunities require that applicants are eligible to work in the specified country/location, unless otherwise stated in the job description. Whitehall Resources are an equal opportunities employer who value a diverse and inclusive working environment. All qualified applicants will receive consideration for employment without regard to race, religion, gender identity or expression, sexual orientation, national origin, pregnancy, disability, age, veteran status, or other characteristics.
