Clinigen

👥 251-500 Pharmaceutical Industrial Manufacturing💼 Private Company

Clinigen is a global specialty pharmaceutical and services company focused on delivering vital medicines worldwide. We operate within a complex regulatory landscape, ensuring timely and secure access to essential medications for patients. Our services span managed access programs, pharmaceutical manufacturing, and consulting. Clinigen's unique combination of businesses positions us as a leader in our field, and we're consistently innovating to address evolving market needs and improve patient outcomes. We currently employ over 1100 people across the globe. Our technology stack supports a range of functions, including analytics with Hotjar and secure hosting through Irish server infrastructure. We're committed to leveraging data effectively and integrating technological solutions to improve our processes and services. We value a collaborative and supportive work environment. Our current job postings highlight exciting opportunities in various departments and locations, reflecting our global reach. Clinigen has experienced rapid growth since its founding in 2010 and maintains a strong presence in the UK, US, EU, JAPAC, and South Africa. We offer competitive salaries and benefits packages, including opportunities for professional development and career growth within a fast-paced and dynamic company culture. We’re proud of our achievements, including successful acquisitions that bolster our capabilities and expand our service offerings. Our commitment to innovation and patient-centric care continues to drive our success and propel our ambitious growth strategy.

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Jobs at this company:

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🔥 Senior Project Manager (Pharmacovigilance)

Posted 22 days ago

📍 United States

🔍 Pharmaceutical

🔧 Requirements

Prior experience working in a contract research organization (CRO), pharmaceutical and/or biotech company.
Broad working knowledge of Clinical and/or Post-marketing PVG and safety reporting requirements under the FDA/International regulations, ICH/GCP guidelines and other relevant requirements.
Effective communicator (written and oral); concise, accurate and business appropriate
Excellent attention to detail and effective organization
Demonstrated critical thinking and problem-solving skills
Ability to manage multiple tasks with deadlines
Proven effective collaboration with other functional areas
Excellent interpersonal skills
Computer literacy in MS Word, Excel and PowerPoint.

💡 Responsibilities

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.

Posted 22 days ago

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🔥 Medical Representative (Account Executive) - Remote Commercial

Posted 23 days ago

📍 Nihonbashi, Tokyo, Japan

🔍 Pharmaceutical or Medical

🔧 Requirements

Medical Representative License in Japan
BA degree
Mid-level proficiency in Word, Excel, and PowerPoint
Native-level Japanese language proficiency
10+ years experience within pharmaceutical or medical industries advantageous
Exceptional written and verbal communication skills
Strong time management skills, with the ability to prioritise and re-prioritise work accordingly
Excellent attention to detail
Demonstrated experience in identifying efficiency issues and implementing improvements
Competent computing skills, specifically utilizing emails and databases
Service orientated, team-focused approach to work

💡 Responsibilities

Medical Information Service and Sales Activities in the territory
Hearing AEs and collecting detailed safety case reports through good liaison with HCPs and pharmacovigilance colleagues.
PMS (Post Marketing surveillance) administrative support and monitoring support
Effectively implement customer relationship management (REPWISE), customer target segmentation, customer pre- and post-call planning, activity planning and execution, call reports, customer needs analysis, customer motivation, vendor applications, time management, customer training and all other related customer relationship activities under the regulation compliance.
Continuous market analysis to identify trends, changes and new sales opportunities
Generate and increase product sales revenue and build Clinigen Brand Value that will turn into long-term good relationships with HCPs
Liaising with Commercial Head and relevant Product Managers with respect to the effective evaluation, realisation and implementation of various business opportunities in the designated territory
Proper planning required to understand objectives and desired outcomes from each sales call
Achievement of sales targets set out and agreed upon
Advertising, promotion and training in support of key customer needs and requirements
Analyse sales data to improve results and make sure resources are effectively allocated
Assist with the arrangement and presentation of company activities / conferences / speakers and other promotional events
Hold explanatory meetings for Clinigen products, as per customer requests
Compile, reconcile and submit of monthly sales reports related to the position. These reports must be submitted as per agreed timelines

Project ManagementSalesforceCommunication SkillsAnalytical SkillsCustomer serviceAttention to detailTime ManagementComplianceExcellent communication skillsReportingTrainingData entryRelationship managementSales experienceMarket ResearchComputer skillsData analyticsCustomer SuccessPowerPoint

Posted 23 days ago

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🔥 Freelance QPPV (EU and UK). Various EU Locations Considered.

Posted 23 days ago

📍 France, Spain, Italy

🧭 Contract

🔍 Pharmacovigilance

🔧 Requirements

Experience in acting as a QPPV
Expert knowledge of PV legislation in territories where assigned as the QPPV
Minimum of at least 7 years' demonstrated experience in managing or implementing PV systems, including quality assurance experience
Documented experience in all aspects of PV in order to fulfil the responsibilities of QPPV.
Extensive knowledge of global pharmacovigilance regulations and GVP and GCP guidelines.
Experience in pharmacovigilance safety risk management including clinical trials, post-marketing pharmacovigilance, safety case processing, safety reporting, and safety system.
Experience in participation in audits and Regulatory authority inspections.
Life Science Degree
Fluent in written and spoken English with strong verbal and written communication skills.
Demonstrated ability to influence, work collaboratively within key stakeholders, effective communicator and analytical thinking ability.
Extensive knowledge in MS Office Applications and Systems.

💡 Responsibilities

Act as the Qualified Person for Pharmacovigilance and/or Local Contact Person for PV for the EU and UK, ensuring compliance with EU and UK pharmacovigilance legislation.
Oversee pharmacovigilance activities, ensuring that all safety issues are identified, assessed, and managed appropriately.
Ensure the timely submission of safety reports to regulatory authorities and maintain effective communication with stakeholders.
Establish and maintain the pharmacovigilance system, including safety databases and processes for reporting adverse events.
Work closely with cross-functional teams, including regulatory affairs, medical, and clinical operations to ensure compliance and to implement risk management plans.
Provide guidance and support for safety-related matters for clinical trials and in the post-marketing settings.
Support with audits and inspections to ensure compliance with internal procedures and regulations.
Stay up to date with changes to pharmacovigilance legislation and guidelines and implement necessary changes throughout the organisation.

Posted 23 days ago

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🔥 Senior Regulatory & Medical Writer - (12 Month FTC)

Posted 26 days ago

📍 United Kingdom

🧭 Contract

🔍 Pharmaceutical

🔧 Requirements

A degree in life sciences (e.g., Biology, Pharmacology, Medicine, or related fields) is required; advanced degree (e.g., MSc, PhD, MD) preferred.
Minimum 3 years’ experience as a medical writer within a pharmaceutical, biotech, or CRO environment, with experience in authoring clinical and/or regulatory documentation.
Familiarity with drug development processes, regulatory submission requirements, and guidelines.
Experience with clinical trial documentation and regulatory submissions.
Excellent written and verbal communication skills, with a strong attention to detail and commitment to accuracy and quality.
Ability to interpret complex scientific data and present it in a clear and concise manner.
Knowledge of clinical research terminology, medical literature, and regulatory guidelines.
Understanding of biostatistics principles.
Strong organisational and project management skills with the ability to manage multiple deadlines.
Collaborative mindset and ability to work effectively in a team environment.
Critical thinking and problem-solving skills to address challenges and improve document processes.
Proficient in Microsoft Office Suite (Word, Excel, PowerPoint).
Proficient with reference management tools (e.g., EndNote, Reference Manager, Zotero).

💡 Responsibilities

Develop, write, and edit various scientific and regulatory documents, including clinical study reports, investigator brochures, CTD modules, briefing documents, and manuscripts for publication.
Ensure all documents comply with regulatory requirements, industry guidelines and internal company standards.
Participate in interpreting and planning of data presentation to be used in individual study reports and summary documents for nonclinical and clinical programmes.
Contribute to the development of templates, style guides, and writing best practices.
Assist in responding to Regulatory Agency queries and document revisions as required.
Collaborate with cross-functional teams, including nonclinical and clinical team members, regulatory affairs staff, biostatisticians, and medical affairs, to gather information and ensure the accuracy of scientific data.
Review and incorporate feedback from team members and stakeholders, in line with project plan and timelines
Together with senior regulatory affairs colleagues, ensure alignment of work with client objectives and relevant regulatory requirements.
Ensure adequate medical writing resources are available for assigned project and consistency between documents.
Attend and contribute in client meetings, lead comment resolution/roundtable meetings.
Perform quality control reviews of documents to ensure consistency, grammar, and adherence to templates.
Ensure that all content meets the highest standards of clarity, accuracy, and scientific integrity.
Conduct literature reviews and stay up-to-date with relevant medical and pharmaceutical guidelines.
Provide scientific expertise in interpreting data and transforming it into clear documents/summaries.
Together with senior regulatory affairs colleagues, ensure that all documents comply with applicable regulatory requirements, industry guidelines, and company standards.
Maintain up-to-date knowledge of regulatory writing trends and pharmaceutical industry standards.

Posted 26 days ago

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