Submission SpecialistDeze vacature staat offline! | ||
| De opdrachtgever | ||
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Grote farmaceut nabij Schiphol | ||
| Belangrijkste taken | ||
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To submit clinical studies Phase I to IV, non-interventional studies if applicable to Ethics Committee and Competent Authorities. All tasks are conducted in accordance with applicable Policies, Standard Operating Procedures (SOP), Work Instructions (WIs) and conventions, as well as current ICH Good Clinical Practice (ICH GCP) and applicable local regulations. Contacts | ||
| EXTERNALLY | ||
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Competent Authorities Ethics committees Clinical trial sites: Principal Investigators, Sub-investigators, and study coordinators, Project Leaders. Vendors and CROs CRA’s KEY TASKS & RESPONSIBILITIES If appropriate and in agreement with the line manager the Specialist can also be responsible for parts or all of the following activities depending on the requirements of the region National Submissions Specialist • Prepare Ethics Committee and Regulatory Authorities submission package for initial trial submission • Prepare Ethics Committee and Regulatory Authorities submission package for any future trial notifications or amendments subsequent to the initial trial submission • Liaise with the monitoring team to ensure the required documentation is collected from sites to meet submission deadlines. • Adapt ICF as per local requirements, perform corresponding back-translation as applicable • To review/adapt patient tools as per local requirements • Prepare translations of other documentation required for submissions as applicable. • Provide translations of any communication to and from IEC/regulatory bodies. • Provide back translation quality check as applicable • To review and approve labels for IMP, provide translation as required. • Liaise with Ethics Committees and Regulatory Authorities in case of issues/objections in cooperation with the Trial Management team and/or corporate regulatory (Regulatory Europe) to provide responses to questions in a consistent and timely manner. • To facilitate and track regulatory and ethics approvals • Generate and track the collection of FDA 1572 if required /trial. Generic Responsibilities • To maintain and develop PC skills required to work efficiently. • Maintain skills by appropriate skills refreshers and training. • To work independently with minimal supervision giving rigorous attention to administrative details • Serve as a resource within for maintaining a long-term memory of evolution of policies, procedures and other practices relating to Clinical Development. • To promote and maintain effective communication with all interfaces and represent PA & CM in interdepartmental process improvement initiatives (see above). • To proactively interface with other departments to promote compliance with policies, procedures, regulations etc and keep up to date with events relevant to the efficient and effective running of clinical trials. • Other additional responsibilities may be assigned, as appropriate. | ||
| CANDIDATE’S PROFILE | ||
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EDUCATION/LANGUAGES Biological science/pharmacy/nursing degree, Nursing qualification, SCRA/PCRA experience or regulatory experience at an equivalent level. Proven track record demonstrating thorough knowledge of ICH GCP and applicable local regulations (e.g. EU/ FDA regulatory requirements for drugs or biologics). Experience in relevant therapeutic areas. Understanding of drug development process. Excellent oral and written communication skills in Dutch & English. PROFESSIONAL SKILLS & EXPERIENCE (desirable) Experience with submission to Ethics Committees and Competent Authorities Experience of regulatory inspection. Experience in a study start up team / feasibility collection Evidence of creative problem-solving skills. PERSONAL SKILLS & COMPETENCIES Proficient PC skills: Word, Excel, PowerPoint, e-mail. Excellent organisational ability and flexibility. Strong interpersonal skills. Highly self-motivated and proactive, with a keen attention to detail. Excellent time-management skills. Goal orientated, able to effectively prioritize and execute tasks in a high-pressure environment. Ability to be a team player. Ability to work from home (if applicable). | ||
| Contactinformatie | ||
Heb je interesse in deze vacature, meld je direct aan middels de button 'aanmelden' of neem contact op met:
Geïnteresseerden kunnen hun c.v. ook rechtstreeks mailen naar andrea@pharmamediair.nl. |
