Vacancies Open at Thermo Fisher Scientific

Job Description

• Prepares, reviews and coordinates, under guidance, local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy.
• Provides, under guidance local regulatory strategy advice (MoH &/or EC) to internal clients.
• Provides project specific local SIA services and coordination of these projects.
• May have contact with investigators for submission related activities.
• Key-contact at country level for either Ethical or Regulatory submission-related activities.
• Coordinates, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation.
• Achieves PPD’s target cycle times for site.
• May work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable.
• May develop country specific Patient Information Sheet/Informed Consent form documents.
• May assist with grant budgets(s) and payment schedules negotiations with sites.
• Supports the coordination of feasibility activities, as required, in accordance with agreed timelines.
• Enters and maintains trial status information relating to SIA activities onto PPD tracking databases in an accurate and timely manner.
• Ensures the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs.

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Essential Functions:  

• Ensures performance of assigned reviews with high quality, on-time results with more complex analyses or deeper root cause analyses to connect related signal to risks.
• Provides training and guidance to junior team members.
• May participate in a project lead or development specialist role, or a combination of both.
• Project leadership activities include: Leads the design and setup of study specific tools and centralized monitoring plan for data review; manages review timelines, develops analysis assignments for team, and supports budget management; organizes, communicates with internal team, and delegates as appropriate to ensure reviews are completed on-time, on budget, with high quality; assists with report development, delivers reports, and leads centralized monitoring meetings; contributes to risk assessment through the completion of the department risk assessment tools. Participates in the cross-functional risk assessment review meetings and contributes to overall risk planning.
• Specialist activities included focused efforts on the development of new tools and analyses within area of specialty.

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 5+ years’).
• Prior experience in clinical monitoring, data management, biostatistics or related field in support of clinical trials is preferred.

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Responsibilities:

• All duties of Operator 1, Manufacturing, which are:
• Correct use of PPE
• Follow all policies & procedures
• Raise hazards observed
• Meet daily production schedule
• Tier 1 meeting participant
• Cleaning procedures for all equipment
• Cleaning procedure for all areas
• Safe operation of equipment
• Preparation, set up and operation of all automated preparators
• Use of Autoclave
• Operating an automated filling machine
• Supplement preparation & addition – automated/ semi-automated products
• Handling & maintenance of silicone tubing
• Operating peristaltic pump systems
• Line opening & in-process manufacturing checks
• Aseptic techniques and following GMP guidelines
• Packing, sealing & labelling of products
• Equipment calibration and use
• Correct completion of QMS documentation (GDP)
• Sampling for QC & retention
• Stock counting
• Back up Operator 1, Manufacturing role
• Solid understanding of technical, operative and administrative methods
• Dry preparation of all products (weighing of dry components)
• Wet preparation of all products (incl. pH control)
• Hand pouring technique
• Supplement preparation & addition – Hand poured products
• Equipment calibration & use (balances, pH meter etc.)
• Identify & escalate material requirements (raw materials & consumables)
• Assisting with Root cause analysis of non-conformances
• Investigation, actioning and completing of an NCR
• Training of Band 1 Operators