Clinigen

Project Manager

• Manage daily interaction with Clients, Sponsors and staff to assist in developing and implementing project-specific safety plans, safety documents, SOPs and guidelines to reflect specific work processes.
• Assist with Safety Management Plan development and safety database configuration and ensure project team is up to date on all relevant changes.
• Ensure that relevant data is entered and maintained in the safety database system in collaboration with the Medical/Safety business unit.
• Ensure Pharmacovigilance files for assigned projects are properly maintained and/or provided to Records Management in a timely manner.
• Manage communications between appropriate team members, Clients, and Sponsors when safety issues are identified.
• Participate in training sessions and workshops, including presenting reports from any conferences attended, as agreed.
• Monitor compliance metrics, project budgets, and service level agreements for assigned projects to ensure regulations and timelines are being met and activities performed are within the approved budget.

Senior Project Manager, Pharmacovigilance

Manager

• Take ownership of Clinigen’s quality and technical activities as a global Marketing Authorisation Holder (MAH).
• Lead relationships with Contract Manufacturing Organisations (CMOs), distributors, and quality partners worldwide.
• Oversee quality investigations, including product complaints, deviations, CAPAs, and change controls.
• Manage key quality documentation such as Product Quality Reviews (PQRs), master batch records, and product files.
• Coordinate product stability programmes and support new product onboarding in collaboration with cross-functional teams.
• Plan and conduct GxP audits of CMOs, laboratories, and warehouses, ensuring supplier qualification and compliance.
• Support regulatory and quality system development, including internal audits and training.
• Act as a Quality ambassador, promoting GMP/GDP compliance, continuous improvement, and a culture of operational excellence.
• Ensure all Quality Technical Agreements are current and that product safety and compliance are maintained at all times.
• Prepare for and support audits (customer, supplier, and regulatory) while contributing to data analysis and continuous improvement initiatives.
• Take proactive ownership of your own professional development and stay informed on key compliance topics such as falsified medicines.

Quality Manager – Commercial Products

Customer Support

• *We welcome applications from individuals based within a commutable distance to our Burton-On-Trent, Staffordshire or Weybridge, Surrey offices.*
• **Key Responsibilities:**
• Self-Managed with ability to self-check work whilst handling a range of customer contact within a customer service environment, using knowledge and skills gained through training to provide our customers with an outstanding level of service in an efficient and effective manner. Customer contact is referencing, but not exclusive to, in and outbound telephone calls, emails, faxes and any digital platform related activity required to support our customers. An Account Executive will be trained on a range of systems related to support our service offering and will be required to showcase a professional and polished service whilst utilising these systems. A flexible approach is required as services may be subject to change. Expectation to deliver world class support and guidance to a range of global customers within the Customer Service department through:
• **Order and enquiry handling:**
• - Within set SLA’s, and referencing the relevant internal reference instructions, process customer orders and enquiries accurately, efficiently in full through to completion to deliver the right drug, to the right patient, at the right time
• - Adhere to set regulatory, legislative, and compliance-based SOP’s whilst handling customer data and in accordance with Clinigen processes
• - Process quotations and product sourcing enquiries in line with training and reference documents for respective regions
• - Keep up to date with Standard Operating Procedures to ensure order and enquiry handling compliance
• - Log any compliance-based enquiries in the Quality system as per SOP (excursion of stock, complaints, non-conformances etc.)
• - Develop relationships with our customers to deal with enquiries first time and in full, where possible. Soft skill communication is clear and apparent at all times
• **Training and Process:**
• - Complete an ‘onboarding’ training program specific to your Customer Services role and upon further experience, assist to deliver this training to new starters
• - Ensure familiarisation and confidence in using all systems and processes within the Customer Services department in line with our departmental training hub and reference documents
• - Input in improving customer experience by communicating any process constraints or improvement activity ideas
• - Expectation to attend all compliance-based refresher training programs set by the Training Manager
• - Provide constructive feedback to Clinigen using the Peakon system to showcase our expertise and to help be the voice of our customers
• - Comply with all internal practices and SOPs. Customer Service authored SOPs should be well known
• - Strive to achieve personal objectives set by line manager and relevant departmental KPIs and attend regular check ins with your line manager to record these in the company appraisal portal
• - Develop and maintain an understanding of all relevant Clinigen and client products to support our customer needs
• - Familiarise yourself with internal colleagues’ processes to ensure a collaborative nature in our exchanges
• **Customer Relationship & Support:**
• - Respond to inbound calls, emails and faxes consistently meeting and maintaining the department KPIs ensuring that response times for the customer does not fall outside of SLA
• - Follow company guidelines whilst thinking quickly and outside the box to offer solutions to meet the customer’s needs
• - Make outbound calls to our customers to support strategic projects or for a business requirement
• - Ability to de-escalate calls and emails in an effective manner and know when to escalate to senior team members for resolution support
• - Build long-term and ongoing external customer relationships through effective communication and interpersonal skills to ensure repeat business opportunity
• - Collaborate with internal Clinigen Teams to ensure the customers account is compliant and created according to their needs i.e., online access
• - Develop and maintain effective long-term working relationships with all internal customers and support functions within the business to aid customer management
• - Ability to communicate and engage with a high level of professionalism and flexibility to adapt to our customers demands as per language and cultural requirement
• - Support the customer needs in line with departmental KPIs
• - When appropriate, promote Clinigen Direct and encourage customers to process their own orders through the digital platformEnsure that complaints and non-conformances are captured in line with our SOP’s and corrective actions are
• - implemented promptly to ensure customer relationship is maintained. Awareness to escalate when required.
• - Work in a flexible manner to assist and support other areas of the Customer Service department and customers as and when necessary
• **Additional duties:**
• The list of duties is not intended to be exhaustive but gives a general indication of the tasks involved. It is the nature of the company that tasks and responsibilities are, in many circumstances, unpredictable and varied. All employees are, therefore, expected to work in a flexible way when the occasion arises and acknowledge that tasks not specifically covered in their job description are not excluded.

Customer Service Account Executive – Italian Speaking

Human Resources

• Providing professional support and advice to internal customers on a range of employment issues including conditions of service, policies and procedures, employment legislation and good practice.
• Assisting our people managers in dealing with HR matters as appropriate with confidentiality and to appropriate time scales. To include:
• Short and long-term sick handling including home visits, welfare meetings, GP reports, Occupational Health referrals as required
• Capability/Performance case management
• Disciplinary case management
• Resolution (Grievance) case management
• Flexible working applications/ processes
• Family friendly processes
• Supporting the HR Business Partners when required with change management processes such as consultation handling, TUPE, restructure, redundancy etc.
• Facilitating the development of HR skill in managers by advising and training on matters of employment law and best employment practice and the interpretation of terms and conditions and HR policies and procedures
• Supporting managers to use our performance assessment system to identify development needs and priorities
• Maintaining the Staff Handbook and associated policies and procedures, in line with current legislation and Clinigen process.
• Encouraging enforcement of the Staff Handbook, taking advice from the HR Operations Manager and external employment law resource where necessary
• Producing and checking correspondence in relation to changes of employee terms and conditions of employment and interface with payroll services on changes to salaries
• Leavers processing, to include acknowledgement letters, final salary calculations and exit interviews
• Supporting the recruitment process for allocated roles, including preparation of recruitment documents, drafting and placement of job adverts, coordination of interview schedules and testing, liaison with candidates and recruitment agencies, conduct telephone screens and interviews with hiring managers.
• Continually review our recruitment processes to ensure they are effective and suggest process improvements where required
• Participate in and provide support for the design, development, and implementation of overall recruiting strategy
• Supporting the implementation of projects within the business, such as graduate recruitment, social media implementation, employer branding, diversity and inclusion best practice
• Supporting the HR Coordinators/Payroll Manager/Finance with monthly payroll processing
• Supporting with changes to staff details in line with payroll cut-off
• Assisting with the preparation and delivery of line leader training programmers on HR related matters. Ensure the content of the training is relevant to training needs identified, and in line with current best practice and legislation
• Ensuring accuracy of information when inputting into the HR system
• Producing reports from the HR system and monitor key metrics as required (absence, staff turnover, headcount etc.)
• Creating and maintaining personal, employment, payroll and staffing establishment information and records in both the manual filing system and the HR system. Ensure that paperwork and systems pertaining to personnel are administered and maintained in accordance with the Staff Handbook, company policy, best practice and relevant industry regulation.

HR Advisor – 1 Year FTC

• Manages and compiles all specifications to ensure that proposals and contracts, including change orders are forwarded to sales staff or clients/prospective clients in a timely manner
• Enters work orders and subsequent change orders into the contact database
• Participates in work order review meetings with applicable resources and participates in project management meetings as needed
• Performs timely follow-up and maintains an up-to-date contact database
• Compiles and updates information for pricing and company guidelines for sales contracts

Proposal and Contract Manager

• Manage daily interaction with Clients, Sponsors and staff to assist in developing and implementing project-specific safety plans, safety documents, SOPs and guidelines
• Assist with Safety Management Plan development and safety database configuration and ensure project team is up to date on all relevant changes
• Ensure that relevant data is entered and maintained in the safety database system in collaboration with the Medical/Safety business unit
• Ensure Pharmacovigilance files for assigned projects are properly maintained and/or provided to Records Management in a timely manner
• Manage communications between appropriate team members, Clients, and Sponsors when safety issues are identified
• Participate in training sessions and workshops, including presenting reports from any conferences attended
• Monitor compliance metrics, project budgets, and service level agreements for assigned projects to ensure regulations and timelines are being met and activities performed are within the approved budget
• Function in compliance with applicable domestic and international regulations and applicable ICH/GCP guidelines to ensure services are provided in accordance with client and PVG policies, procedures, and contractual agreements

Operations

• Accountable for ensuring all Quality team operations at CSM USA comply with GxP regulations, Clinigen Quality Systems, and industry standards.
• Provide leadership across quality activities and represent the department on project teams to drive consistent, controlled quality actions aligned with global expectations.
• Lead the implementation and integration of a robust Quality Management System (QMS) in compliance with GxP regulations and guidelines.
• Oversee Quality Assurance operations and systems, ensuring current GxP compliance across site activities.
• Develop and maintain a Quality Risk Management framework in line with ICH Q9.
• Manage the Quality Batch Release process, ensuring compliance with regulatory and company standards.
• Oversee product recall operations and collaborate with Marketing Authorization Holders and Competent Authorities as required.
• Ensure qualification and validation of facilities, equipment, processes, and computerized systems.
• Work cross-functionally with business areas to drive operational excellence and customer satisfaction.
• Lead site quality review meetings and escalate key issues to senior management when required.
• Engage directly with clients to strengthen relationships, resolve quality-related issues, and identify opportunities for improvement.
• Ensure business continuity through effective back-up planning and cross-training of staff.

Quality Operations Manager

Procurement

• Manage the end-to-end purchasing process for products, including vendor selection, order placement, and delivery tracking.
• Develop and maintain strong relationships with suppliers to ensure product availability and compliance with contractual agreements.
• Collaborate with cross-functional teams to identify and implement cost-saving initiatives and improve purchasing efficiency.
• Monitor inventory levels, evaluating demand patterns and adjusting orders to meet business needs.
• Analyze purchasing data and report on performance metrics, addressing issues and recommending strategies for improvement.
• Ensure compliance with regulatory requirements and company policies related to procurement and purchasing activities.
• Assist in resolving discrepancies with vendors concerning pricing or product availability.
• Support the Purchasing Manager in the execution of strategic sourcing projects as needed.
• Work closely with international suppliers and internal teams to execute procurement strategies, optimize inventory levels, and support operational efficiency.

Purchasing Executive

• Administrative and strategic HR responsibilities: employee relations, recruitment, performance management, training and development
• Serve as the HR communication professional for the site, communicating policies, changes, events and important information to employees
• Manage employee relations issues, address concerns and grievances, conduct investigations for fair resolutions
• Liaise with line managers and staff to facilitate open and honest communication
• Prepare and check payroll and salary transfer in cooperation with Finance; act as back-up for payroll and admin functions
• Engage in works-council related discussions and draft works-council agreements
• Support hiring managers as single point of contact for recruitment and selection processes
• Conduct employee onboarding to ensure smooth transition for new hires
• Manage human resource projects and provide regular progress reports to stakeholders
• Connect with Learning and Development Partner for site training and development needs
• Collaborate with HR team members from business units and the global team to support company initiatives
• Support compensation projects as required
• Build relationships, simplify and support internal processes and business requests in a timely manner
• Maintain confidentiality, present the Company positively, engage in professional development and attend mandatory training

HR Generalist

• Assist with the planning and coordination of daily operational activities
• Support the demand planning function by managing inventories and forecasting
• Ensure stock levels are maintained and discrepancies are addressed promptly
• Prepare and maintain accurate records and reports related to operations
• Collaborate with cross-functional teams to ensure seamless operations and communication
• Handle queries and provide support to internal teams and external stakeholders
• Assist in the implementation of operational improvements and best practices
• Participate in training and development initiatives for staff as required
• Contribute to the maintenance of a safe and compliant working environment

Operations Assistant

Compliance

• Clinigen, a rapidly growing global specialty pharmaceutical services business, is seeking a detail-oriented and motivated Regulatory Associate to join our dynamic team.
• Assist in the preparation and submission of regulatory documents
• Maintain up-to-date records
• Provide support for regulatory inquiries
• Work closely with the Regulatory Affairs team and other departments to facilitate timely delivery of projects
• Ensure all regulatory submissions are accurate and complete
• Grow career in regulatory affairs and contribute to the success of products

Regulatory Associate / Senior Associate

• Working with international suppliers to source hard to find medicines at competitive rates
• Handling inbound unlicensed sourcing enquiries
• Pursue multiple options to achieve cost reductions e.g. negotiate rebates, exploit price breaks, mitigate cost price increases, improve payment terms etc.
• Tendering of large value product requirements where appropriate
• Establish and develop supplier and manufacturer relationships
• Leverages a detailed understanding of marketplace, competitors and business requirements
• Constructs detailed cost models/purchase price analysis of goods and services to drive the control, containment and reduction of costs for Clinigen and to provide deep and meaningful insights to the Commercial team’s
• Understanding of unlicensed product acquisition needs across the Clinigen group and taking advantage of synergies
• Performs detailed analysis of supplier proposals and payment schedules and conducts rigorous price negotiations with suppliers
• Maintain and expand global supplier base to ensure development and contribute to the global sourcing strategy
• Strategy development/implementation: Utilizes Sourcing process, other tools and techniques to create and execute RFIs, RFQs together with subsequent structured information analysis wherever possible using internal and external datasets
• Find opportunities to increase spend and portfolio of products that are sourced direct from manufacturer and ensure Clinigen Group has a commercial edge over competitors
• Review of product needs, targeting key manufacturers for direct purchasing and exclusivity
• Work with business development and commercial teams to pursue partnerships for key products
• Ongoing review of new and emerging suppliers, competitors and market dynamics at global level

Sourcing Specialist

Analyst

• Serves as a key resource for interpreting data and information; communicates results to team members
• Operates as a key contact between departments and IT to facilitate the delivery of business intelligence solutions
• Works closely with IT project managers and operations to coordinate cross-functional project activities and ensure deliverables are accurate and meet customer requirements
• Utilizes business intelligence tools across all departments and functional areas providing detailed reporting and analysis
• Assesses analytics and reporting needs; in time providing recommendations for enhanced solutions and specifications for business intelligence tools
• Supports the delivery of BI solutions to internal and external customers
• Supports prioritization of reporting needs across process areas to support deployment strategies and business needs
• Supports development of protocols to extract data in a standardized process from a variety of data sources
• Supports development and definition of data management standards and processes to effectively manage data through the reporting life cycle
• Supports data mining of customer and sales force information for all relevant market segments
• Supports development of prototypes and models for database, data integrations and data transformation needs
• Maintains and develops strong working relationships with business owners as a process advocate
• Supports creation of speech and presentation materials for members of the management team
• Keeps abreast of healthcare trends and competitor activity

Junior Analyst

Financial Planning and Analysis

• Clinigen is a global specialty pharmaceutical and services company operating in a complex regulatory environment, ensuring vital medicines are delivered securely and on time.
• FP&A Manager will direct all commercial finance and management reporting activities across the CSM business unit.
• Lead the CSM commercial Finance Team responsible for budgeting, forecasting, internal reporting, P&L, Balance Sheet, and Cash Flow management.
• Own provision of monthly management accounts and KPIs, consolidation of global CSM results, monthly business review packs, rolling forecasts, and the annual budget and long-range processes.
• Review sales commission plans and payout calculations to ensure financial governance and quarterly commission reviews.
• Provide financial input on business or investment projects (ERP, regulatory changes, M&A, licensing deals, divestments).
• Support sales leadership with financial review of new business opportunities and RFI responses.
• Review and improve systems and processes, integrating local EU and US processes with the global finance strategy.
• Must live within 60 miles from Malvern, PA, USA.

Finance Business Partner, FP&A

Customer Success Manager

• Clinigen is a rapidly growing global specialty pharmaceutical services business with over 1,000 employees and offices in the UK, US, EU, Asia Pacific and South Africa.
• Proactive, client-focused Client Engagement Manager generating sales leads for the Managed Access Division and supporting targeting, conference strategies, and digital engagement.
• Generate sales leads for Business Development against pre-defined target assets and companies; support qualification of target assets.
• Conduct client outreach via social media, telephone, email and conferences; create compelling client-specific hooks to secure direct contact opportunities.
• Identify target decision makers and work with Marketing to ensure coverage of target assets, people and companies; support Thought Leadership positioning.
• Support horizon scanning and liaison with conference organisers; support BD before and during industry conferences to drive lead generation.
• Maintain BD MA SharePoint elements and develop SME status in Salesforce use; collaborate with internal stakeholders to leverage existing Clinigen relationships.

Client Engagement Manager – Pharmaceutical

• Company Responsible Person for Link Healthcare Malaysia
• Manage Sales & Marketing and Medicine Access business including Named Patient Supply (NPS), Expanded Access Programs (EAP) and registered products
• Oversee clinical trial services, medical information support and business development for portfolio expansion
• Lead product planning, product management, pricing, tender support and product launches
• Manage sales forecasts, budgets, inventory and sales reporting
• Ensure pharmacovigilance, regulatory compliance (NPRA) and quality management adherence
• Build and manage relationships with key hospital influencers and customers
• Ensure team training, customer clinical support and timely responses

Senior Project Manager, Pharmacovigilance

Quality Manager – Commercial Products

Customer Service Account Executive – Italian Speaking

HR Advisor – 1 Year FTC

Proposal and Contract Manager

Senior Project Manager, Pharmacovigilance

Quality Operations Manager

Purchasing Executive

HR Generalist

Operations Assistant

Regulatory Associate / Senior Associate

Sourcing Specialist

Junior Analyst

Finance Business Partner, FP&A

Client Engagement Manager – Pharmaceutical

Senior Market Access Manager