Fresh Vacancies at Thermo Fisher Scientific

Job Description

Key Duties and Responsibilities:

• Partner with the Specialty Diagnostics Commercial Leader for South Africa to drive top line growth in the Business Unit
• Pro-actively analyze data trends, making and driving improvements in execution with the management team; and present business issues to management and propose actions.
• Provide and business assessment information to make business decisions (e.g. product line profitability, pricing, promotions, rebates, and customer profitability). Improve on tools used by management to run business.
• Responsible to provide timely, accurate and reporting to the leadership and partners as requested and as required to ensure business issues are communicated and acted upon in a timely manner.
• Identify, communicate, and recommend/implement actions
• Case preparation and analysis/justifications of investment projects and customer contract proposals for larger/more projects as assigned. Includes modeling to ensure prioritisation and return on investment.
• Analyze the global information of the Business Unit and boost in the evaluation of alternatives to drive growth
• Assist in the development and preparation of strategic plan, budget, forecasts, and monthly results
• Drive improvement and standardization in reporting within the Business Unit.  Understand key Business Unit operating metrics (price realization, volume performance, SMG&A spending, etc.) and measure performance to the established metrics.
• Perform projects and ad-hoc financial reporting as required
• Align with financial statutory requirements and in accordance with South African law
• Lead all aspects of audits (internal & external), collaborated closely with auditors and implement actions
• Compile South African Reserve Bank (SARB) & STATS SA regulatory reports

Knowledge, Skills, Abilities

• The successful candidate is personable, highly and thrives in a collaborative environment.  They have excellent, open, and proactive communication capabilities, identifying and addressing issues via an open dialog.
• Possess strong leadership skills and outstanding analytical and problem solving abilities
• Outstanding communication and interpersonal skills
• Self motivated with high bias for action
• Track record of developing important relationships at all levels within an organization – at both the business unit and divisional/group level, and can operate effectively in a matrix reporting structure.
• High level of energy; can bring a passion to excel.  Able to energize and influence a wide spectrum of people, including senior financial and operational professionals. 
• Possess a strong set of personal and business values that coincide with those of the 4Is. 
• Believes in and demands accountability.
• Ability to thrive and lead in a sophisticated, global business environment.

Job Requirements

• An undergraduate degree in Finance or Accounting is required; an MBA is helpful.  Should possess excellent academic credentials, a strong proficiency in financial analysis, as well as a technical foundation in accounting. 
• The successful candidate will be a well-rounded finance professional with a focus. They should have a minimum of 8 years of dynamically responsible business experience.  Experience in a multi-site, global manufacturing organization is desired.  
• Solid understanding of Excel (i.e., financial models and analysis), Cognos reporting tool (or equivalent), PowerPoint, and Hyperion Financial Management (HFM) is required.
• The successful candidate should expect travel of up to 20%.

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Job Description

How will you make an impact?

The Pharmacist Assistant will be responsible for the safety, quality, and efficacy of all medicines within the premises. They ensure that all activities of that facility are completed, which often involves expediting the receiving and shipping of goods, and ensuring efficient, organized storage of products.

Candidate be self-motivated, willing, and able to do whatever is required to meet our customers’ needs, have solid interpersonal skills, be a fast learner with the ability to adapt very quickly to change and get ahead of issues and problems.

Purpose:

• The position, with limited supervision and with appropriate training on software tools and processes, is capable of coordinating time critical cold chain shipments, process receipts and returns and perform inventory management activities relating to clinical trials.  High levels of are required and the candidate must have the knowledge and confidence to identify areas for improvement and with limited oversight develop solutions to achieve our service goals. 

Responsibilities:

• Ensures that clinical supplies are received, stored, distributed, returned, and destroyed in accordance with Fisher Clinical Services approved Standard Operation Procedures, policies, cGWP, cGDP and regulatory requirements.
• Assist in maintaining the FCS South Africa Quality System in compliance with SOPs and policies by supporting all warehouse activities and operational functions related to correct and accurate document flow.
• Adhere to SOPs and other relevant documentation required by law and study protocols for specific projects.
• To assist the Responsible Pharmacist or Deputy Responsible Pharmacist in implementation of changes to pharmacy plans, SOPs, and other relevant documentation.
• Perform accurate data capturing and complete relevant paperwork of all operational activities performed.
• To supervise and maintain the drug inventory on a regular basis and assist in investigation of internal and external non-conformances or complaints through to resolution.
• To supervise drug storage conditions.
• Participate in study-related training and development and achievement of the company goals and objectives.

Education / Experience Requirements:

• Matric/Grade 12.
• Registered as a Post Basic Pharmacist Assistant at the South African Pharmacy Council, SAPC.

Crucial Skills and Attributes:

• Detailed orientated.
• Results driven individual
• A hands-on individual who can operate independently and with minimum supervision.
• An analytical problem solver, able to communicate in a clear and proactive manner.
• Hard-working to meet project plan objectives in set timelines.
• Well-spoken and presentable with high ethical standards.
• Work well within a team.
• Computer literate.
• Adaptable

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Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.  

Our global Clinical Operations colleagues within our PPD® clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies. 

We have an exciting opportunity for Senior Manager Clinical Operations within our wonderful team in Türkiye!

Summarized Purpose:

Manages, selects, trains, resources, coaches and performance management of respective staff, which may be inclusive of CAS, CS, CRAs, CTCs, ACRAs and/or other clinical operations focused staff. Focuses on end results using metrics and key performance indicators to manage performance. Leads or contributes to initiatives that enhance the department's performance or lead to process improvement across the company.  Collaborates with clinical operations senior management and executive staff on strategic planning and business development. Acts as point-of-escalation regarding performance concerns and training needs to ensure adherence to the company's SOPs and WPDs. Works in collaboration with the leadership team for resourcing needs.

Essential Functions:

• Manages staff, providing coaching, mentorship and work direction.
• Conducts regular performance appraisals and career discussions with staff.
• Facilitates employee career development. Interviews, recruits and selects staff.
• Manages and conducts induction/orientation programs for all new employees, ensuring their smooth assimilation into the company.
• Ensures all staff CVs, training records, position profiles and experience profiles are complete and up-to-date. Ensures timeliness and accuracy of timesheets and expense reports.
• Supports allocation activities per the local resourcing process. Supports activities of project leads/functional leads to optimize the operational running of projects.
• Escalates appropriately any issues which may impact project deliverables.
• Delivers training on Working Practice Documents (WPDs) and Standard Operating
• Procedures (SOPs), local requirements and any other subjects that impact on clinical operations. Identifies training gaps and ensures that training requirements are met.
• May contribute to development of training programs, where appropriate.
• Assures adherence to good ethical and regulatory standards.
• Alerts management to quality issues, request QA audits as appropriate, and facilitate client and internal quality assurance audits as required.
• Manages and reviews systems (e.g. Activate, CTMS, Preclarus, Clarity) to evaluate employee and project metrics, KPIs and general project status.
• Evaluates work of staff, including conducting MAs (either remote or on-site) to thoroughly evaluate the employee monitoring skills and project conduction when applicable.
• Participates in process improvement/development initiatives.
• Ensures understanding and facilitation of the risk-based monitoring approach.
• Provides input into bids and contribute to the procurement of new business where required.
• Assists senior management in budgeting activity of assigned group(s) and supports annual and long-range forecasting.

Qualifications:

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 8+ years).
• 2+ years of management responsibility

Knowledge, Skills and Abilities:

• Excellent mentoring/leadership/supervisory skills
• Excellent clinical trials monitoring skills; Remote and on-site
• Advanced knowledge of clinical trials monitoring; Remote and on-site
• Advanced understanding of or ability to learn the company’s SOPs, WPDs, and relevant regulations (e.g.
• ICH/GCP, FDA guidelines)
• Demonstrated ability to evaluate medical research data
• Advanced organizational and negotiation skills
• Strong attention to detail
• Excellent written and oral communication skills
• Good knowledge of English language and grammar
• Advanced use of computer to include data entry, archival and retrieval
• Ability to travel as needed
• Excellent team player with team building skills
• Excellent interpersonal and conflict resolution skills
• Excellent ability to utilize problem-solving techniques applicable to constantly changing environment
• Advanced knowledge of medical/therapeutic areas and medical terminology

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Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Summarized purpose:

• Provides medical review and analysis for clinical trial serious adverse events, marketed products ICSR and periodic safety reports (e.g. PBRER, PSUR, DSUR), as well as other client deliverables (e.g. labeling reconciliation documents, CTD modules, REMS, RMP, Signal detection reports and CSR).

Essential functions:

• Maintains understanding of methods for recording time spent on project and administrative tasks, expense submissions and travel.
• Ensures tasks delegated to PVG are properly executed. Adheres to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues. Adheres to client SOPs/directives and project specific WPDs for assigned projects. Adheres to PPD’s corporate policies and SOPs/WPDs.
• Provides medical consultation to team members and answer all project/study related medical questions. Communicates clearly with associates and clients, maintaining an open line of communication to ensure all procedures are followed appropriately.
• Provides safety reporting training on assigned projects/studies, as requested.
• Medically reviews adverse event and serious adverse event data from all sources (solicited, spontaneous, literature, etc) as contracted.
• Provides medical review of adverse events of special interest, serious adverse events and clinical outcomes events reported in Clinical Trials.
• Performs data review as specified in the client contract and data validation manual including review of coding listings and/or full safety data to assess for potential safety concerns.
• Assists in writing (interpretation of safety data) and/or review of CSR, IND/NDA report, ICSR, signal detection reports, periodic reports, RMP, REMS, CTD modules, etc. to ensure that the medical content is accurate and complete.
• Manages signal detection activities, scientifically reviews periodic safety reports, contributes to label updates, supports dossier maintenance and risk management activities.
• Serves as a consultant and spokesperson for the functional area or as an external spokesperson for the organization on highly significant matters. Creates formal networks with key decision makers.

Education/experience:

• MD or equivalent required. History of an active medical license highly preferred.
• Candidates should have at least one of the following:
• Clinical experience in having direct responsibility for diagnostic and treatment decisions (comparable to 2 years); Or
• Direct experience in medical review and assessment of safety information/Pharmacovigilance (comparable to 3 years).

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Job Description

Thermo Fisher Scientific is seeking an exceptional individual to join our team as an Account Manager III. In this role, you will have the opportunity to drive the AgriBusiness Commercial Strategy in South Africa and Full English Speaking Countries in Africa. This unique opportunity allows you to make a significant impact in achieving individual and team success in supporting the Sales and Support AgriBusiness EMEA team to achieve financial targets.

Location: Johannesburg/ remote.

Major Responsibilities:

• Directly sell the AgriBusiness portfolio in Animal Health and Genotyping applications in the assigned area
• Achieve both quarterly and annual sales targets
• Develop and implement a strategy to increase customer value creation and market share gain in specific geographies
• Maintain and develop relationships with senior-level customers
• Gather, analyze, and deliver information to develop market-specific strategies and products
• Identify and focus on key accounts and key opinion leaders to build a long-term growth strategy
• Identify competitor activities and develop tactical activities
• Manage distributor relationships
• Manage and maintain an accurate Funnel and Forecast process according to company standards

Skills/Experience Required:

• Hold an academic degree (BSc) or have equivalent experience in Veterinary Diagnostics & Agrigenomics market
• Minimum 3 years of experience in Specialist Sales, with a proven track record in veterinary diagnostics or related field
• Bench experience in Veterinary Diagnostics & Agrigenomics
• Understanding of production animal diagnostics workflows and animal genotyping products, applications, and instruments
• Knowledge of Molecular Biology Applications: Sample Prep, qPCR, NGS, Microarray
• Willingness and ability to travel extensively (50-60% travel time)

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Job Description

Performs and coordinates different aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or supervising environments (i.e. FSO, FSP, Government, etc.). Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task matrix.

Key responsibilities:

• Monitors investigator sites with a risk-based monitoring approach,applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks.
• Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities.
• Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards.
• Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution.
• May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner.
• Conducts supervising tasks in accordance with the approved monitoring plan.
• Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution.
• Investigates and follows-up on findings as applicable. 
• Participates in investigator meetings as vital. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites.
• Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials. 
• Ensures that required crucial documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications. 
• Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required.
• Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System). 
• Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts. 
• Responds to company, client and applicable regulatory requirements/audits/inspections. 
• Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner. 
• Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members. 
• Contributes to other project work and initiatives for process improvement, as required.