Pharm-Olam International

*Why Pharm-Olam* Pharm-Olam, LLC is a mid-size Contract Research Organization (CRO) that has a massive global reach. We are a company that strives to deliver cost-effective, quick-to-market clinical services in today's emerging marketplace. Pharm-Olam has one of the largest global footprints of any CRO today and we are committed to not only maintain our standard, but to continue to strengthen our presence even further. We offer a unique working environment with a global team culture, competitive salary and benefits package. *This is Important Work* Typically under the direction of a Global Site Contract Sr. Manager , the Global Site Contract Manager, will oversee and manage the contract and budget negotiation at study level, supporting the Local Site Activation Associate(s) and Global Site Budget Analyst(s) assigned during the start up phase. The Global Site Contract Manager will work with Client Services, Legal, Business Development and Operations in the production and preparation of accurate, legally binding and effective Agreements that protect the interests of Pharm-Olam. As part of an ongoing contract management function, the Global Site Contract Manager will revise the text for site contracts after the specific out of scope work has been identified by the Project Manager/Global Site Activation Manager and approved by the Client. The Global Site Contract Manager will manage contracts through Pharm-Olam's internal approval process before these are sent to the Client. The Global Site Contract Manager will work with Legal in providing regular review of contract documentation and in the update, review and development of new templates, processes and tools to assist in the contract processes and to ensure contracts are in compliance with Pharm-Olam policies and procedures. This is a full-time, direct hire opportunity for an experienced candidate with site contracts / budget negotiation experience. Ideal candidate should be hands on & able to provideoversight on details and quality as well as adherence to the processes. *Your Role* * Responsible to attend the KOM and cover all aspects related the Clinical Trial Agreement(s) and budget negotiation process as well as discussion and completion of the CTA questionnaire * Responsible for managing the development of Clinical Trial Agreement and Budget Plan (CTABP) that must be signed prior 1st site is selected * Responsible for managing the coordination of Site Contracts & Budgets: will work alongside the Global Site Activation Manager/PM and Global Site Budget Analyst to manage the negotiations of contracts and budgets with sites and internal team (Local Sites Activation Associates) according to the instructions agreed at the study level, and obtains sponsor approval on the Country-specific investigator budget draft including negotiation ranges and requirements for escalation. * Responsible to provide sponsor with CTA questionnaire, general CTA template and fall back language * Responsible to provide Local Site Activation Associate(s) with approved CTA questionnaire, English general CTA template in track-changes and fall back language and incorporated into country templates, when using the Pharm-Olam contract template * Responsible to incorporate Sponsor changes into the draft Country CTA templates and have it reviewed and approved by the Local Site Activation Associate(s) and to obtain sponsor approval for the draft Country CTA template, when using the Pharm-Olam contract template * Responsible to review Sponsor template and fall back language provided by the sponsor at study level and share sponsor CTA template with the Local Site Activation Associate(s) for local revision, when using the Sponsor template * Responsible to get Draft Country CTA templates approved by sponsor, when using the Sponsor template * Responsible for team training on CTA and Site Budget negotiation with the Global Site Budget AnalystResponsible to get the final draft of CTA and site budget approval at site level * Development and ongoing maintenance of templates and tools to assist in the management of the contract processes, e.g. template CDA, CTA . * Participate in client contract negotiation, including group negotiation calls and direct client communication. * Present at internal and/or external meetings Including Bid Defenses: prepare and deliver presentations in collaboration with relevant departments * Responsible for appropriate issue escalation program to appropriate stakeholder(s) * Other duties as required. * Your Team: * * Report directly to Global Site Activation Manager/PM at a project level * Liaise extensively with Legal, Client Services, BD and Operations * Communicate with external clients as needed during the contracts negotiation process *Required Education and Qualifications* * Paralegal certification preferred or equivalent contract review experience * 5-7 years prior experience with pricing and contracts desirable * A minimum of 5 years' experience within the CRO/Pharmaceutical industry with an understanding of clinical trial processes * Excellent computer skills with good working knowledge of a range of computer programs including CTMS systems. * Strong written and verbal communication skills * Strong experience in contract negotiations and demonstrated ability * Excellent time management skills and attention to detail * Technical writing experience a plus * Experience working with cross-functional teams required * Manage critical projects and drive multiple projects simultaneously independently * Ability to travel domestically and internationally as required. * Ability to effectively attend and present at internal and external meetings (such as internal webinars or Bid Defence meetings) * A thorough understanding of the drug development process. *Apply Now* Please apply online at Pharm-Olam, LLC provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. To connect with our community, follow Pharm-Olam on LinkedIn.

*Why Pharm-Olam* Pharm-Olam, LLC is a mid-size Contract Research Organization (CRO) that has a massive global reach. We are a company that strives to deliver cost-effective, quick-to-market clinical services in today's emerging marketplace. Pharm-Olam has one of the largest global footprints of any CRO today and we are committed to not only maintain our standard, but to continue to strengthen our presence even further. We offer a unique working environment with a global team culture, competitive salary and benefits package. #LI-Remote *This is Important Work* Typically under the direction of a Global Regulatory Sr. Manager, the Global Regulatory Manager, will be responsible for managing regulatory activities in multiple countries participating in global trials; developing and implementing strategies for timely approvals of Phase I through Phase IV applications; counselling and overseeing the local site activation associates; ensuring timely preparation and submission of regulatory documentation to European and international drug regulatory authorities as well as Independent Ethics Committees (IEC)/Institutional Review Boards (IRB); ensuring the quality, content and format of regulatory submissions; and interacting with project team members and development partners; serving as a direct Pharm-Olam point of contact for regulatory questions raised by the Sponsor, Upper Management, Client Services, BD Auditors and Inspectors. The Global Regulatory Managerwill be responsible and accountable to keep the Site Activation Milestones (RA/IEC/IRB submission and approval) on track during the course of the study(s) managing the Local Site Activation Associate (s) therebyensuring that expectations are met while identifying and mitigating the start up risks. This is a full-time, direct hire opportunity for an experienced Global Regulatory Professional with a strong background supportinga variety of clinical trials. *Your Role* * Responsible to attend the KOM if required and cover all aspects related RA/IEC/IRB submission and approval. * Responsible for the development of Regulatory and Ethics Submission Plan (RESP) that must be signed prior 1st submission is performed. * Coordinate the preparation of regulatory as well as ethics submissions to Regulatory Authorities as well as IEC/IRB, including original Clinical Trial Applications as well as amendment submissions: will work alongside the Global Site Activation Manager/PM ensuring submissions are performed according to internal and client expectations. * Plan realistic timelines for submissions and approvals at study & country level, day to day management during study start-up. * Act as a source of information for Sponsor, Upper Management, Global Site Activation Manager, Client Services, Pharmacovigilance, BD Auditors and Inspectors for Safety Requirements in countries participating in a clinical trial * Coordinate with other departments to achieve project goals. * Represent the company in interactions with RA/EC reviewers to pursue approvals, obtain information, and clarify issues * In certain circumstances, may be the spokesperson for the Company in discussions with the EMA, other agencies or other companies * Access regulatory agency websites and/or contact regulatory authority at regular intervals for updates on regulations, guidelines and procedures. Ensure these changes and updates are communicated and circulated as appropriate * Coordinate the Local Site Activation Associates assisting the preparation, compilation and submission to Regulatory Authority (RA) and Independent Ethics Committee (IEC)/ Independent Review Board (IRB) until the corresponding approvals are in place * Responsible for Master Subject SIS/ICF Review and Finalisation cycle with Sponsor and distribute Approved Master Subject SIS/ICF to the countries * Responsible for Country and/or Site-Specific (*if applicable) SIS/ICF Review/ Finalisation and Approval Cycle with Sponsor * Your Team: * * Report directly to the Global Site Activation Manager/Project Manager if no GSAM assigned at a project level * Oversight and support of Local Site Activation Associate (s) within study team * Collaborate with other Departments and functional groups within Pharm-Olam, including, but not limited to: Project Management, Clinical Operations, Medical Affairs, Medical Writing, Pharmacovigilance, Data Management and Biostatistics, Quality Assurance, Business Development and Marketing Executives * Collaborate with Pharm-Olam Medical, Regulatory, and Legal (and other) Advisors * Liaise with Sponsor scientific, medical, and corporate staff * Liaise with sub-contractors *Required Education and Qualifications* * At least a B.S. degree or other college education equivalent * 5 to 7 years relevant technical and management regulatory experience in the pharmaceutical or CRO industries * Indepth knowledge of the latest relevant international regulations (such as EMA, FDA, ICH/GCP…), guidelines, and regulatory trends * Excellent interpersonal, verbal and written communication skills as well as IT proficiency * Experience in working effectively in a team-based environment * Manage critical projects and drive multiple projects simultaneously independently * Special applicable skills and experience within regulatory field (e.g. medical devices, gene- therapy, Eudravigilance in conjunction with the PVG department, EudraCT registration,VHP registration, IMPD compilation, consulting and review, or similar) * Ability to effectively attend and present at internal and external meetings (such as internal webinars or Bid Defence meetings) * Skills in both strategic thinking and tactical implementation of regulatory strategies * Good computer skills with good working knowledge of a range of computer programs including CTMS systems. * Apply Now * Please apply online at Pharm-Olam, LLC provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. To connect with our community, follow Pharm-Olam on LinkedIn.

*Why Pharm-Olam* Pharm-Olam, LLC is a mid-size Contract Research Organization (CRO) that has a massive global reach. We are a company that strives to deliver cost-effective, quick-to-market clinical services in today's emerging marketplace. Pharm-Olam has one of the largest global footprints of any CRO today and we are committed to not only maintain our standard, but to continue to strengthen our presence even further. We offer a unique working environment with a global team culture, competitive salary and benefits package. *This is Important Work* To develop and maintain training programmes both internal and external as part of the Training Policy within the Pharm-Olam, LLC. *Your Role* * To develop and enhance global training programmes for the Pharm-Olam: * To collate Pharm-Olam training needs and requirements and to develop programmes which enhance the learning process. * To develop the most appropriate learning methods for all levels of staff and all department groups within. * To update senior management on a monthly basis on staff feedback from courses/training materials and application of skills learnt. * To research and recommend additional training and development areas, as required. * To prepare and present training courses/training materials to Pharm-Olam staff or to call on specialised external speakers to assist, as required. * To manage and support country-based trainers based in local Pharm-Olam Group offices. * To keep up-to-date with relevant guidelines and regulations and to develop training methods to update staff in a timely manner. * To develop training courses that can be provided to the Pharmaceutical Industry and provide revenue to Pharm-Olam. * To manage the systematic documentation of training records process worldwide within Pharm-Olam. * Your Team: * * Reports to the Director, Global Clinical Operations and Training * Interaction with all groups within Pharm-Olam and our subcontractors (if applicable), including monitoring, project management, quality assurance and data management * Liaison with training/project staff at all levels *Required Education and Qualifications* * Experience in curriculum design in a pharmaceutical environment. * Significant training and development of training materials experience. * Excellent communication, presentation and interpersonal skills. * Knowledge of GCP/regulatory/clinical/compliance training environment. * Attention to detail. * Apply Now * Please apply online at Pharm-Olam, LLC provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. To connect with our community, follow Pharm-Olam on LinkedIn.