Clinigen

Role Description To remotely assist SG-ANZ markets in Sage transactions, PQR reporting and follow-up (inclusive of back-log clearance), other EDP tasks as assigned. Key Accountabilities: - Timely transactions in Sage - Timely reporting of current PQR - Clearance of ANZ PQR reporting - Timely execution of other EDP tasks as assigned Qualifications - Fresh graduates are encouraged to apply - English and computer literate - Experience in ERP / eQMS experience will be an advantage Benefits - A competitive monthly salary that reflects your experience, skills, and the industry standards, ensuring that you are fairly compensated for your hard work and dedication.

Role Description We are seeking a confident and proactive Paralegal to join our Legal team based remotely to support the business in relation to all Legal matters detailed below. - Liaise with the business, customers and agencies in relation to the preparation, review and negotiation of CDA’s. - Administer Legal & Compliance Inbox and Legal Front Door system for allocating matters received from the business within the Legal Team. - Act as the initial contact point (and manage the portfolio of standard responses), for any Requests for Information (RFIs), that require legal input. - Monitor and manage the weekly Managed Access Tracker. - Liaise with the business regarding the sanctions screening processes as required. - Provide administrative support to Senior Legal Counsel, and the external agency managing the Company’s intellectual property portfolio. - Provide ad hoc legal support to the Legal Team on legal, corporate and other compliance projects as required from time to time. - Provide administration and logistical support to Legal Team such as researching, drafting, and checking documents. - Administer the GEMs database (company contract database or its replacement), and the Legal SharePoint site. - Maintain and update the internal Paralegal Manual. - To act with the highest integrity at all times and in line with the Company Handbook, Clinigen’s values and culture, to provide a best, first-class service. - Keep up to date with UK Company laws to ensure we are in full compliance. Benefits - 27 days, plus bank holidays - Discretionary Bonus - Pension contributions & Life Assurance scheme - Flexible Benefits Platform with £25/month Company contribution - Annual salary review - Independent financial advice service - Enhanced Employee Assistance Programme - Shopping discounts with retailers - Long service awards - Recognition scheme & employee of the year awards Company Description Clinigen is a rapidly growing global specialty pharmaceutical and services company with a unique combination of businesses. Our divisions operate in a complex global regulatory environment and ensure that vital medicines are delivered securely on time and wherever they are needed in the world. We are currently 1,100 people headquartered in the UK with global offices in the US, EU, JAPAC and South Africa. Clinigen has grown rapidly since it began in 2010 and is positioned well for an exciting future of continued expansion.

We are looking for a proactive PV Officer and/or Senior PV Associate to work within the Clinigen Lifecycle Services team and will be dedicated to one or more of our pharmaceutical clients with a truly global presence supporting the collation, processing and analysis of safety information on behalf of a Client(s) product(s); this unique industry-changing relationship redefines collaboration. This role requires you to be a passionate pharmacovigilance professional, who is a dedicated and enthusiastic team player, that wants to work with a new business that strives to gain and maintain an exceptional reputation as a PV Service Provider that is knowledgeable, cares and produces high quality work We are looking for applicants based in Central and Eastern Europe (remote), Malaysia and South Africa. **Key Responsibilities:** - Working within the Pharmacovigilance Operations team - Assess and process serious adverse events (SAEs) and Individual Case Safety Reports (ICSRs) into the Global Drug Safety database - Support quality and efficiency strategies within the organisation - Assisting in departmental regulatory inspection preparedness for the company pharmacovigilance system and actively participating in PV inspections or audits as required - Contributes to improvements of team processes. - Other PV operational activities or initiatives as assigned - Maintaining good client relations and ensuring a consistently high quality of work for each client. - Review of Medical Information Enquiries and Product Quality Complaints to ensure all safety information has been captured. **For the Clients** - Managing mailboxes – responding to data entry / case processing queries from Clients and Client Partners, providing responses - Triage, tracking and forwarding of safety data from client Managed Access Programmes. - Case processing of SAEs and/or ICSRs - Case regulatory reporting; preparing relevant cases for submission and sending to the relevant Regulatory Authorities - Working on E2B/R3 format reporting and Case Finalization; reading error messages and taking steps to correct cases as a result of negative acknowledgments. - Supporting investigation of cases of non-compliance of SAEs/ICSRs - Performing Literature Article reviews - Performing follow-up related to queries and requests regarding case handling - Communicating with Clients and/Partners regarding the evaluation and processing of ICSRs - Performing quality-control of cases in the Global Drug Safety database - Performing reconciliation activities as per Client contracts and each Client Operating Guideline (COG) - Assists when required in Partner, Health Authority Audits/Inspections. - Participation in Client audits and inspections **Additional Duties** - The list of duties is not intended to be exhaustive, but gives a general indication of the tasks involved; - Support the collation and dissemination of quality and compliance metrics for pharmacovigilance and medical information activities - 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

• Identify prospective clients and contacts, generate sales calls and schedule meetings, coordinate and attend sales presentations to clients and prospective clients • Sell Clinigen Clinical Supplies Management solutions to qualified contacts and perform solutions-based presentations to current and prospective clients • Ensure all clients are knowledgeable about Clinigen Clinical Supplies Management services through sales and marketing efforts that include regular sales calls to develop relationships and formal presentations with prospective clients • Obtain new requests for proposals and forward them to the Contracts & Proposals team for processing • Partner with the Contracts & Proposals team to ensure contracts including CDA’s, MSA’s, quotes and work orders meet required timelines • Participate in industry conferences and tradeshows to meet prospective clients and increase industry awareness of Clinigen Clinical Supplies Management services

• Identify prospective clients and contacts, generate sales calls and schedule meetings, coordinate and attend sales presentations to clients and prospective clients • Sell Clinigen Clinical Supplies Management solutions to qualified contacts and perform solutions-based presentations to current and prospective clients • Ensure all clients are knowledgeable about Clinigen Clinical Supplies Management services through sales and marketing efforts that include regular sales calls to develop relationships and formal presentations with prospective clients • Obtain new requests for proposals and forward them to the Contracts & Proposals team for processing • Partner with the Contracts & Proposals team to ensure contracts including CDA’s, MSA’s, quotes and work orders meet required timelines • Participate in industry conferences and tradeshows to meet prospective clients and increase industry awareness of Clinigen Clinical Supplies Management services

Role Description We are looking for a Proactive PV Officer and/or Senior PV Officer to work within the Clinigen Lifecycle Services team and will be dedicated to one or more of our pharmaceutical clients with a truly global presence supporting the collation, processing and analysis of safety information on behalf of a Client(s) product(s); this unique industry-changing relationship redefines collaboration. This role requires you to be a passionate pharmacovigilance professional, who is a dedicated and enthusiastic team player, that wants to work with a new business that strives to gain and maintain an exceptional reputation as a PV Service Provider that is knowledgeable, cares and produces high quality work. We are looking for applicants based in Malaysia and Croatia. Applicants based in EU and South Africa are also welcome. Key Responsibilities: - Working within the Pharmacovigilance Operations team - Assess and process serious adverse events (SAEs) and Individual Case Safety Reports (ICSRs) into the Global Drug Safety database - Support quality and efficiency strategies within the organisation - Assisting in departmental regulatory inspection preparedness for the company pharmacovigilance system and actively participating in PV inspections or audits as required - Contributes to improvements of team processes - Other PV operational activities or initiatives as assigned - Maintaining good client relations and ensuring a consistently high quality of work for each client - Review of Medical Information Enquiries and Product Quality Complaints to ensure all safety information has been captured For the Clients: - Managing mailboxes – responding to data entry / case processing queries from Clients and Client Partners, providing responses - Triage, tracking and forwarding of safety data from client Managed Access Programmes - Distribution of SUSARs to enrolled physicians within MAP as per agreement with client - Case processing of SAEs and/or ICSRs - Case regulatory reporting; preparing relevant cases for submission and sending to the relevant Regulatory Authorities - Working on E2B/R3 format reporting and Case Finalization; reading error messages and taking steps to correct cases as a result of negative acknowledgments - Supporting investigation of cases of non-compliance of SAEs/ICSRs - Performing Literature Article reviews - Performing follow-up related to queries and requests regarding case handling - Communicating with Clients and/Partners regarding the evaluation and processing of ICSRs - Performing quality-control of cases in the Global Drug Safety database - Performing reconciliation activities as per Client contracts and each Client Operating Guideline (COG) - Assists when required in Partner, Health Authority Audits/Inspections - Participation in Client audits and inspections Additional Duties - The list of duties is not intended to be exhaustive, but gives a general indication of the tasks involved - Support the collation and dissemination of quality and compliance metrics for pharmacovigilance and medical information activities - 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 Qualifications - Healthcare Professional qualification or equivalent of a Bachelor of Science (BSc) degree - Evidence of being able to build relationships with key internal and external customers and demonstrate customer focus - Attention to detail and the ability to work effectively in an environment characterised by tight timelines and changing priorities - Excellent organizational and prioritization skills and strong analytical / problem solving skills - Excellent oral and written communication skills - Ability to build relationships with key internal and external customers - Excellent attention to detail and ability to work under pressure - Extensive knowledge of MS Office Applications and systems - Outstanding written, verbal, and interpersonal communication skills - Excellent ability to handle multiple tasks in a fast-paced and constantly changing environment - Proven ability to work collaboratively within a matrix and/or cross-functional environment - Self-motivated and organised, with the ability to work unsupervised for periods of time - Excellent analytical thinking, with the ability to evaluate and present complex safety data applying sound judgement Benefits - 27 days, plus bank holidays - Discretionary Bonus - Pension contributions & Life Assurance scheme - Annual salary review - Enhanced Employee Assistance Programme - Long service awards - Recognition scheme & employee of the year awards

Role Description We are looking for a Proactive PV Officer and/or Senior PV Officer to work within the Clinigen Lifecycle Services team and will be dedicated to one or more of our pharmaceutical clients with a truly global presence supporting the collation, processing and analysis of safety information on behalf of a Client(s) product(s); this unique industry-changing relationship redefines collaboration. This role requires you to be a passionate pharmacovigilance professional, who is a dedicated and enthusiastic team player, that wants to work with a new business that strives to gain and maintain an exceptional reputation as a PV Service Provider that is knowledgeable, cares and produces high quality work. Key Responsibilities: - Working within the Pharmacovigilance Operations team - Assess and process serious adverse events (SAEs) and Individual Case Safety Reports (ICSRs) into the Global Drug Safety database - Support quality and efficiency strategies within the organisation - Assisting in departmental regulatory inspection preparedness for the company pharmacovigilance system and actively participating in PV inspections or audits as required - Contributes to improvements of team processes - Other PV operational activities or initiatives as assigned - Maintaining good client relations and ensuring a consistently high quality of work for each client - Review of Medical Information Enquiries and Product Quality Complaints to ensure all safety information has been captured For the Clients: - Managing mailboxes – responding to data entry / case processing queries from Clients and Client Partners, providing responses - Triage, tracking and forwarding of safety data from client Managed Access Programmes - Distribution of SUSARs to enrolled physicians within MAP as per agreement with client - Case processing of SAEs and/or ICSRs - Case regulatory reporting; preparing relevant cases for submission and sending to the relevant Regulatory Authorities - Working on E2B/R3 format reporting and Case Finalization; reading error messages and taking steps to correct cases as a result of negative acknowledgments - Supporting investigation of cases of non-compliance of SAEs/ICSRs - Performing Literature Article reviews - Performing follow-up related to queries and requests regarding case handling - Communicating with Clients and/Partners regarding the evaluation and processing of ICSRs - Performing quality-control of cases in the Global Drug Safety database - Performing reconciliation activities as per Client contracts and each Client Operating Guideline (COG) - Assists when required in Partner, Health Authority Audits/Inspections - Participation in Client audits and inspections Additional Duties: - The list of duties is not intended to be exhaustive, but gives a general indication of the tasks involved - Support the collation and dissemination of quality and compliance metrics for pharmacovigilance and medical information activities - 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 Qualifications - Healthcare Professional qualification or equivalent of a Bachelor of Science (BSc) degree - Evidence of being able to build relationships with key internal and external customers and demonstrate customer focus - Attention to detail and the ability to work effectively in an environment characterised by tight timelines and changing priorities - Excellent organizational and prioritization skills and strong analytical / problem solving skills - Excellent oral and written communication skills - Ability to build relationships with key internal and external customers - Excellent attention to detail and ability to work under pressure - Extensive knowledge of MS Office Applications and systems - Outstanding written, verbal, and interpersonal communication skills - Excellent ability to handle multiple tasks in a fast-paced and constantly changing environment - Proven ability to work collaboratively within a matrix and/or cross-functional environment - Self-motivated and organised, with the ability to work unsupervised for periods of time - Excellent analytical thinking, with the ability to evaluate and present complex safety data applying sound judgement Benefits - 27 days, plus bank holidays - Discretionary Bonus - Pension contributions & Life Assurance scheme - Annual salary review - Enhanced Employee Assistance Programme - Long service awards - Recognition scheme & employee of the year awards

• Primary point of direct contact for communication with Clinigen’s customers i.e. hospitals, physicians and pharmacists. • Responsibility for servicing customer needs and providing information and support for the range of Clinigen and client products to assigned customer accounts. • Ensure all enquiries and orders are processed accurately following set systems and processes. • 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. • 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. • Develop relationships with our customers to deal with enquiries first time and in full, where possible. • Training and Process to ensure familiarization and confidence in using all systems and processes. • Customer Relationship & Support to maintain effective long-term working relationships.

• Assist in achieving sales targets, monthly and annually • Assist in the development of sales strategies and action plans for the market based on the respective marketing plans that ensure attainment of company sales goals and profitability • Implementation and execution of all agreed strategic activities in accordance with the sales strategy • Liaising with global Business Development team - with respect to the effective evaluation exploitation and implementation of various business opportunities in designated territories • Ensuring that all internal resources, where needed, are utilized effectively to ensure that sales targets are achieved • Responsible for the performance, coaching and development of the regional BD team • Conduct one-on-one reviews with direct reports to build more effective communications, to understand training and development needs, coaching needs and to provide insight for the improvement of sales and activity performance • Assist regional team in preparation of proposals and presentations • Implements Performance Improvement Programs for direct reports not achieving sales targets • Ensures that all direct reports meet or exceed all activity standards for prospecting calls, appointments, presentations, proposals and closes • Delegates authority and responsibility with accountability and follow-up to the regional team • Conducts regular coaching with direct reports to build motivation and selling skills

Role Description To support our growth, we are seeking a dynamic, entrepreneurial and driven Regional Business Development Director who has a razor-focused hunter mindset. This is a brand new and exciting opportunity where you will be given full autonomy and ownership for business development and client relations activities for clinical supply services. The Regional Business Development Director will be responsible for the development and performance of all sales activities in assigned market, along with leading a team to achieve maximum profitability and growth in line with Clinigen's vision and values. This is an excellent opportunity for a Senior or Business Development Director operating in Clinical Supply Services Sales who is looking to progress to Regional Business Development Director or a BD Director seeking more autonomy in their role. What your role at Clinigen looks like: - Assist in achieving sales targets, monthly and annually - Assist in the development of sales strategies and action plans for the market based on the respective marketing plans that ensure attainment of company sales goals and profitability - Implementation and execution of all agreed strategic activities in accordance with the sales strategy - Liaising with global Business Development team regarding the effective evaluation, exploitation, and implementation of various business opportunities in designated territories - Ensuring that all internal resources, where needed, are utilized effectively to ensure that sales targets are achieved - Responsible for the performance, coaching, and development of the regional BD team - Conduct one-on-one reviews with direct reports to build more effective communications, understand training and development needs, coaching needs, and provide insight for the improvement of sales and activity performance - Assist regional team in preparation of proposals and presentations - Implements Performance Improvement Programs for direct reports not achieving sales targets - Ensures that all direct reports meet or exceed all activity standards for prospecting calls, appointments, presentations, proposals, and closes - Delegates authority and responsibility with accountability and follow-up to the regional team - Conducts regular coaching with direct reports to build motivation and selling skills Qualifications - 10+ years’ experience selling in a business-to-business environment within the pharmaceutical and/or biotechnology industries - 6+ years’ experience selling Clinical Supplies or Clinical Service solutions - Degree in Business, Marketing, Communications, Life Sciences or related field of study or equivalent work experience required - Prior experience managing, directing, coaching, mentoring and overseeing direct reports preferred - Advanced knowledge, understanding and background in Clinical Supplies, Marketing, Sales and Business Development principles and processes Requirements - Demonstrable record of consistent achievement of results and sales targets - Proven ability to sell solutions-based services with the highest regard for actively listening to and understanding dynamic client needs - Excellent knowledge of the pharmaceutical and biotechnology industry related to clinical supplies processes - Ability to actively pursue assignments, take initiative, evaluate situations, adapt to change and make decisions in a timely manner - Superior verbal, written and interpersonal communication skills to work effectively across the organization as well as interact with all applicable stakeholders - High regard for confidentiality in dealing with all clients, proprietary and pharmaceutical related information - Self-motivated with exceptional time management skills to prioritize work and meet deadlines - Ability to develop effective working relationships with associates at all levels to influence others and foster a cooperative work environment across the organization Benefits - 401(k) - 401(k) matching - Dental insurance - Employee assistance program - Employee discount - Health insurance - Health savings account - Life insurance - Paid holidays - Paid time off - Parental leave - Professional development assistance - Referral program - Vision insurance Company Description Clinigen is a rapidly growing global specialty pharmaceutical and services company with a unique combination of businesses. Our divisions operate in a complex global regulatory environment and ensure that vital medicines are delivered securely on time and wherever they are needed in the world.