Post-market Clinical Follow-up
3 mesi fa
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it's the best of both worlds.
**ClinChoice is searching for a Post-Market Clinical Follow-up (PMCF) Medical Writer Consultant for 1 year contract, **to join one of our clients.
**Main Job Tasks and Responsibilities**:
- Responsible for development of Post-Market Clinical Follow-up (PMCF) Plans and Reports
- Collaborates with members of cross-functional teams to prepare PMCF plans and reports within projected timelines with mínimal supervision
- Support rapid responses to requests for additional information from competent authorities, regulatory agencies, and notified bodies
- Support clinical scientific discussions with regulatory agencies/ notified bodies to drive support of the clinical and regulatory strategy
- Support internal and external audits
- Complete training by established due dates
- Provides documents, data, and feedback to Post-market Surveillance (PMS), Clinical Evaluation Report (CER), and Periodic Safety Update Report (PSUR) management and writers, as well as others such as Risk Management, Medical Affairs, and Medical Safety
- May contribute to the development and delivery of appropriate global evidence generation strategies (EGS) and evidence dissemination strategies (EDS) within the assigned projects
- Responsible for communicating business related issues or opportunities to next management level. Function as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders
- Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures
- Perform other duties assigned as needed
- Generally manages work with limited supervision, dependent on project complexity. Independent decision-making for simple and more advanced situations but require mínimal guidance for complex situations
**Education and Experience**:
- Minimum of a bachelor's degree preferably in Life Science, Physical Science, Nursing, or Biological Science required
- Advanced degree desirable.
- BS/BA with at least 4 years, MS with at least 3 years, PhD with at least 2 years of relevant experience preferred
- Previous experience in clinical research or equivalent is required
- Experience working well with cross-functional teams is required
- Experience managing projects is required
- Medical device experience highly preferred
- Extensive experience with EU Commission Regulation 2017/745 Medical Device Regulation (MDR) and/or MEDDEV 2.7 highly preferred
- Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV, )
- Clinical/medical background a plus
- Experience in therapeutic space (breast augmentation and reconstruction) a plus
**Specific Role Requirements and Skills**:
- Good understanding of clinical research science and processes along with an understanding of product development processes, team dynamics, clinical trends, and global clinical trial regulations;
- Ability to provide scientifically strategic and scientific clinical research input across Life-Cycle Management (LCM) projects;
- Ability to provide same for New Products a plus
- Proven track record in delivering clinical projects within clinical/ surgical research setting, on time, and in compliance to SOPs and regulations;
- Strong presentation and technical writing skills;
- Strong written and oral communication skills;
- Strong computer skills and competence with use of Microsoft Excel, Word, PowerPoint, and EndNote or other reference management software
- Demonstrate competencies in the following area are required:
- Behave and lead in a professional and ethical manner
- Advanced technical writing skills
- Advanced project management skills with ability to handle multiple projects
**The Application Process**:
**Who will you be working for?**
**About ClinChoice**:
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
**Our Company Ethos**:
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and clien
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