Our mission is to accelerate access to medicines for patients​ in every corner of the globe: Clinical Services, Product Access and Commercialisation, Pharmacovigilance and Regulatory Affairs.

Clinigen

Browse and apply for open jobs at Clinigen.

project-manager

Clinigen is a specialized pharmaceutical company focused on providing access to medicines for patients worldwide. With a mission to accelerate the journey through clinical development, Clinigen supports pharmaceutical and biotech companies, healthcare professionals, and patient groups by offering services in clinical trial supplies, packaging, labeling, and supply chain management. The company's global reach allows it to facilitate market access and managed access programs, ensuring patients receive innovative medicines regardless of geography. Clinigen also provides regulatory affairs and pharmacovigilance services to enhance patient safety and compliance. Dedicated to sustainability and addressing rare diseases, Clinigen partners with organizations to meet unmet medical needs, while their expertise in licensed and unlicensed distribution furthers their impact across 130+ countries. Their comprehensive services make them a vital player in the healthcare industry, committed to improving patient outcomes globally.

• 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

Senior Project Manager managing client programs and pharmacovigilance at Clinigen. Leading compliance and safety management to ensure project standards are maintained under regulations.

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

Quality Manager at Clinigen overseeing product quality and compliance. Leading a team and managing quality operations for pharmaceutical services in the UK.

data-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 ensures 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 Data Analyst

Junior Data Analyst interpreting data and facilitating business intelligence solutions at Clinigen. Involves cross-department collaboration and analytical reporting in a hybrid work setting.

customer-support

- 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:
- 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.
- 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.
- 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 platform.
- Ensure 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.
- 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 – French Speaking

Customer Service Account Executive liaising with customers and ensuring compliance while efficiently handling inquiries. Delivering excellent customer service through multiple communication channels.

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

Experienced HR Advisor providing HR support and advice to internal customers in a hybrid role. Aiming to facilitate effective HR operations and recruitment strategies for the organization.

pricing-analyst

• Maintain Portfolio & Pricing Framework – Ensure accurate configuration and upkeep of the Global Access portfolio and pricing structure in line with business strategy.
• Conduct Pricing Analysis – Perform competitive pricing research using internal and external data to support new opportunities and portfolio decisions.
• Collaborate on Data Automation – Work with the Business Data & Analytics team to enhance reporting processes and explore AI-driven improvements.
• Manage Portfolio Lifecycle – Oversee product entry/exit through automated reviews, coordinating with master data and customer service teams.
• Monitor Pricing Performance – Maintain trackers and metrics at country and product level, and communicate cost price changes to relevant teams.
• Support Commercial Strategy – Assist in creating market-specific price lists and ensure contract profitability through forecasting and review.
• Ensure Data Accuracy & Compliance – Maintain pricing data integrity in Oracle, resolve discrepancies, and adhere to SOPs and company policies.

Portfolio and Pricing Analyst

Portfolio and Pricing Analyst in Clinigen's Global Access team. Responsible for pricing analysis and data management to support unlicensed medicines provision.

sales

We are preparing to launch a new Human Milk Fortifier product designed to support the health of premature infants. This innovative nutritional solution has already been adopted internationally and is expected to significantly improve neonatal outcomes in Japan.
We are seeking a Sales Manager to lead the execution of strategies that enable healthcare professionals (HCPs) to effectively integrate this product into clinical practice. This position will collaborate with marketing teams and domestic stakeholders to drive adoption within healthcare institutions and play a key role in implementing a new treatment strategy for preterm and low birth weight infants into the Japanese healthcare environment.
Key Responsibilities:
· Develop and implement strategic sales plans to achieve sales target.
· Build strong network with key opinion leaders
· Navigate sales team for full speed of account opening post launch
· Deep understanding of marketing strategy to transit into sales execution
· Monitor sales performance and set clear sales KPIs
· Provide regular feedback to Commercial Lead and motivate a team of sales representatives
· Manage budgets and allocate resources effectively
· Build and maintain strong relationships with healthcare professionals
· Ensure compliance with industry regulations and company policies
· Collaborate with marketing and medical to optimize the product
· Plan and lead regional peer-to-peer engagement among HCPs to enhance early-stage product usability.
Additional Information:
This position requires a strong achievement mindset and adaptability. Responsibilities may evolve based on business needs, and the successful candidate will be expected to embrace flexibility and continuous learning.

Sales Manager, Innovative Medicine

Lead sales launch for Human Milk Fortifier in Japan, building HCP relationships and managing sales team to drive hospital account openings.

Clinigen

About the company

Open jobs