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  • Posted: Aug 11, 2022
    Deadline: Not specified
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  • PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 47 countries and more than 19,000 professionals worldwide, PPD applies...
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    (Senior/Principal) Clinical Team Manager - General Medicine

    Currently, we are looking for an experienced Clinical Team Manager to join our team. This exciting and unique role could take you the next step of your career within Clinical Research. As a Clinical Team Manager (CTM), you combine deep knowledge, therapeutic expertise, and robust tools to help our clients deliver life-changing therapies to market. You take ownership, anticipate problems, find solutions and deliver results

    The role coordinates all aspects of clinical activities on an international basis, including: 

    • Day to day management and leadership of a team of Clinical Operations members who are allocated to a project on a Country basis Responsibility for the achievement of the project clinical deliverables within the contractual timelines and budget
    • Development of clinical tools (e.g. Monitoring Plan and Guidelines) and set up of the required training, tracking and quality systems
    • Work in partnership with the Project Manager to prepare, organize, and present at client meetings, including bid defense and kick off meetings
    • Clinical Resource Management – provide input into preparation of forecast estimates of clinical deliverables, assignments and identification of additional resource requirements
    • Acting as a contact and support to the Sponsor for all clinical-related aspects of the project

    Job Qualification

    Does this sound like you? If so, you need to have:

    • Bachelor's degree or licensed certified health care training or equivalent combination of education and experience
    • Previous cross-country CTM/ Project Management experience in excess of 2 year, including specific knowledge for  General Medicine: Gastrointestinal diseases (NASH, Ulcerative Colitis, Chron’s Disease, Constipation, Inflammatory Bowel Disease); Immunology (Lupus, Rheumatoid Arthritis, Gout, Osteoarthritis); Dermatology (Atopic Dermatitis, Psoriasis); Women’s health and Genitourinary
    • Gene therapy experience would be considered as an advantage
    • Clinical research experience in all phases of study life cycle, including start up, interim and close out
    • Study finance management experience
    • Ability and willingness to cross-region and in region travel according to the project needs
    • Valid Passport and Driving Licence 
    • Be competent in use of written and oral English language

    Knowledge, Skills and Abilities:

    • Superior organizational skills
    • Strategic thinking skills
    • Demonstrated performance management abilities
    • Excellent judgment and decision-making skills
    • Highly effective verbal and written communication and presentation skills
    • Expert knowledge of relevant regulations e.g. ICH/GCP, FDA guidelines, et

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    Director of HR Compliance

    As a Director of HR Compliance, EMEA you will direct a series of HR related programs to make sure requirements are met.The Global HR Compliance Center of Expertise (CoE), is responsible for the governance and oversight for defining and implementing HR policies and procedures to ensure that employment and work practices demonstrate a thorough understanding of laws and regulations and are aligned to HR governance models, philosophies and larger HR objectives.

    Work with the HR Compliance CoE Global Leader to develop and mature the Global HR Compliance center of expertise (CoE). In this role, you will help lead the compliance and governance of HR programs and employment documents focused on regulatory compliance and alignment with PPD HR philosophies, objectives, and strategic priorities. This will be an exciting opportunity for someone with previous experience in HR compliance with broad EMEA regional or global exposure!

    Key Responsibilities

    • Establish and manage a roadmap of HR compliance programs, projects and initiatives for the EMEA region.
    • Implement and manage regional and/or global HR compliance programs where assigned.
    • Develops and maintain an HR compliance knowledge base and framework for the identification and tracking of HR compliance requirements across all functional areas of HR.
    • Establish a framework for understanding and managing collective agreements and works councils’ rules and requirements. Serve as the EMEA program manager for works councils.
    • Support the HR Compliance COE leader with processes for maintaining HR governance models.
    • Conduct research to understand new or changing HR compliance requirements and make recommendations to the COE leader on updating policies, practices, or processes.
    • Draft and maintain employment documents, including employment contracts, non-competition agreements, etc.
    • Vendor management for HR compliance.
    • Conduct gap analysis on HR policies and content and make recommendations to the COE leader for needed updates or changes.
    • Supports HR Compliance COE Leader on due diligence activities for mergers, acquisitions, entity employee transfers, and entity integrations.
    • Stay knowledgeable on regulatory developments within or outside of the company as well as evolving best practices in HR compliance.
    • Prepare reports, at the direction of the COE leader, for senior management and for external regulatory bodies
    • Draft written narratives that articulate obligations, risks and consequences for new or changing regulatory requirements.
    • Provide input on supporting documentation such as manager and employee communications, FAQs, and standard operating processes.
    • Assess employment law and provide recommendations for HR policies, practices, and processes.

    Job Qualification

    The ideal candidate will have a thorough understanding of HR compliance core areas and considerations, preferably from a global perspective and background. Additionally, the candidate will have demonstrated experience implementing, managing, and maintaining HR compliance related programs across all of EMEA or globally and the utilization of project management skills to execute against program objectives.

    Education and Experience: 

    • Bachelor's degree or equivalent and relevant formal academic / vocational qualification.
    • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 10+ years). 5+ years of management responsibility
    • Strong analytical and communication skills

    Knowledge, Skills and Abilities:

    • Ability to operate within a matrixed organization
    • Experience working in a global, large-scale, complex, and fast-paced environment
    • Adaptability and knowledge of HR systems and tools, such as Oracle, ServiceNow, SharePoint, Microsoft Suite, etc.
    • Proven experience with and understanding of US employment law and regulations (global knowledge a plus)
    • Experience working with legal departments or attorneys a plus
    • Ability to oversee initiatives from inception to execution to auditing
    • Capability to manage multiple projects while prioritizing shifting demands based on business needs
    • Experience building cross-functional partnerships and influencing stakeholders across the organization to act without having a direct reporting relationship
    • Reliable team player, accountable for delivering results and ready to help the team
    • Proven analytical capabilities; experience with large amounts of data and in developing audit reports, metrics, and reporting mechanisms
    • Certified compliance professional is a plus

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    Sr Medical Writer, Regulatory

    Our writers possess strong leadership and project management skills, are creative problem solvers and decision makers, are engaging mentors and enthusiastic members of the department with an eagerness to continually improve our offerings and deliver a market leading service to our clients. In return, the medical writing department offers a highly competitive compensation package together with excellent opportunities for personal development and progression within the field. All within a friendly, fast paced and exciting environment.

    The Medical Writer collaborates with internal and sponsor team members to interpret, distill, and summarize complex data concepts. Other tasks include presentation of clinical messages in clinical study reports, summarization of preclinical and clinical studies for preparation of investigator's brochures, and referencing current research and regulatory guidelines for preparation of protocols. Their work documenting clinical study trials covers a wide range of therapeutic indications.

    You will be a part of a team who is dedicated to its people and foster a supportive, collaborative culture based on trust, flexibility and work life balance. 

    Job Qualification

    Qualifications required:

    • Education to Bachelor’s/advanced degree level in a scientific discipline
    • 5+ years of experience within regulatory medical writing
    • Excellent grammatical, editorial and proofreading skills

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    Compliance Specialist - GXP/GLP DOC Management

    As a Compliance Specialist you will execute quality and compliance processes across the organization. This role executes quality and compliance processes across the organization. Facilitates the tracking and reporting of quality and compliance activities. Maintains tools and materials and provides expertise to advance the vision of the department. 

    Essential Functions:

    • Processes and manages SOPs through the lifecycle in the Electronic Document Management System (EDMS).
    • Researches issues, tracks metrics, and maintains reports and documentation related to quality and compliance activities.
    • Administers quality and compliance processes and ensures appropriate execution and completion.
    • Contributes to projects and process/quality improvement initiatives. 
    • Communicates with representatives from other departments to ensure quality and timelines are maintained with respect to compliance activities (e.g., client audits, CAPA and/or procedural documents).

    Job Qualification

    Education and Experience:

    • Bachelor's degree or equivalent and relevant formal academic / vocational qualification
    • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).
    • In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

    Knowledge, Skills and Abilities: 

    • Experience with SOPs/Controlled Documents
    • Experience working in an Electronic Document Management System (EDMS)
    • Laboratory experience will be an advantage
    • Excellent oral andwritten communication skills
    • Solid organizational and time-management skills
    • Firm knowledge of the clinical trial process
    • Knowledge and understanding of relevant GxP regulations and guidelines
    • Effective problem solving skills
    • Strongattention to detail
    • Ability to work independently as required
    • Strong computer skills; ability to learn and become proficient with appropriate software
    • Ability to multitask and prioritize competing demands/work load
    • Demonstrated flexibility and adaptability

    Method of Application

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