We are seeking a Principal Medical Writer to support full Clinical Study Report (CSR) writing for Phase 1 , protocol development, and preparation of regulatory modules (2.7.1/2.7.2) . This role requires strong writing skills and attention to detail to ensure high-quality, inspection-ready deliverables.
Your responsibilities will include: Performing site selection, initiation, monitoring and close-out visits.Supporting the development of a subject recruitment plan.Evaluating the quality and integrity of site practices in accordance with regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution.Collaborating with experts at study sites and with client representatives.Depending on client model there might be remote-monitoring, involvement in study start-up processes, specialization on therapeutic area (pharmaceutical product or medical devices).
Your responsibilities will include: Performing site selection, initiation, monitoring and close-out visits.Supporting the development of a subject recruitment plan.Evaluating the quality and integrity of site practices in accordance with regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution.Collaborating with experts at study sites and with client representatives.Depending on client model there might be remote-monitoring, involvement in study start-up processes, specialization on therapeutic area (pharmaceutical product or medical devices).Mentoring of less experienced team members, support as subject matter expert for specific topics or additional tasks might be included.
Key Responsibilities: • Perform, plan co-ordinate, and implement the following for complex studies: - The programming, testing, and documentation of statistical programs for use in creating statistical tables, figures, and listing - The programming of analysis datasets (derived datasets) and transfer files for internal and external clients - The programming quality control checks for the source data and to report the data issues periodically • Ability to interpret project level requirements and develop programming specifications, as appropriate, for complex studies. • Provide advanced technical expertise in conjunction with internal and external clients, and independently bring project solutions to SP teams • Fulfil project responsibilities at the level of technical team lead for single complex studies or group of studies. • Directly communicate with internal and client statisticians and clinical team members to ensure appropriate understanding of requirements and project timelines • Estimate programming scope of work, manage resource assignments, communicate project status and negotiate/re-negotiate project timelines for deliverables • Use and promote the use of established standards, SOP and best practices • Provide training and mentoring to SP team members Requirements: • Bachelor's Degree in Maths, Computer science, Statistics, or related field • 7+ years’ Statistical Programming experience within the Life Science Industry • Strong Efficacy experience • Advanced knowledge of statistics, programming and/or clinical drug development process • Advanced knowledge of computing applications such as Base SAS, SAS Graph and SAS Macro • Language • Advanced knowledge of relevant Data Standards (such as CDISC/ADaM/SDTM) Join IQVIA to see where your skills can take you • Global exposure • Variety of therapeutic areas • Collaborative and supportive team environment • Access to cutting-edge and innovative, in-house technology • Excellent career development and progression opportunities • Work-Life Balance, with a strong focus on a positive well-being Unleash your potential!
Your responsibilities might include: Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines.Collaborate with clinical team on the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.Assist with periodic review of study files and completeness.Collaborate with CRAs and RSU on the preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.Coordinate the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.Act as a mentor for less experienced Clinical Trial Coordinators and assist with training and onboarding of new colleagues.May serve as subject matter expert for business processes or lead Clinical Trial Coordinators study teams.May participate in departmental quality or process improvement initiatives.
. • Identify risks and contingencies and partner with project leader in problem solving and resolution efforts. • Report to and relate with Trial Leader to provide updates, exchange critical information and share trial conduction information, within regulatory and compliance burdens. • Participate in and actively drive organizational, quality and process improvement initiatives to commence future leading change.
Assist the clinical team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures. Assist with periodic review of study files for completeness.
Participates in planning and reviewing medical sections of Clinical Trial Reports. Qualifications Medical degree from an accredited and internationally recognized medical school. Typically requires a minimum of 5-7 years' experience in clinical medicine.
Your Contribution Promotes and sells the complete pharmaceutical packaging (PP) product portfolio to dedicated international customers in the area responsibilityDefine sales strategy, projects, activities and create customer specific solutions with regards to products, services, conditions and problem solving.Develops and promotes sales growth & margins, aligns with key accounts, product management and marketing strategies / goalsActively analyzes and provides continuous updates about potentials to KAM, product management, marketing, customer service and production departments of product development, market trends, competitor information and new product opportunitiesVisits prospects and customers and provides regular updates and reports on customer/prospect visits and activities of dedicated local and international customersManage, maintain and update the customers’ file and system (CRM, Sales Database) according to established process and procedureWork closely with Customer Service to support him / her for Quotation, Account Receivables and Complaint handlingNegotiation of prices and payment conditions in coordination with the supplying unit or the KAM and give input in the global price negotiationsEstablishes the yearly budget and quarterly forecast for the dedicated local and international customers (per product group and supplying plant)Monitors budget achievement monthly and react accordingly if deviations occur.Assists with customer support for technical issues, audits, concerns, questions and acts as interface between customer, KAM and production siteGenerates customer contacts at various levels and functions (multi-channel selling)It is proactive as a team member and player to implement and reach departmental, plant and corporate objectivesProvides monthly summary reports about activities of domestic and international customers handled.Monthly competitor analysis as supporting data to take the right decision to retain or gain new market share or new customers.Monitoring quarterly Sales achievement to ensure yearly target achieved.Together with the Finance team, monitory Account Receivables on weekly basis to achieve the assigned target.Active participation in company activities that relate with customers, aside from the routine tasks.To ensure sales achievement assigned by company.To ensure customer satisfaction is reached by referring to global surver result.To ensure routine tasks, periodic tasks and variable tasks are well executed.The authority level follows the approval matrix guideline defined by global Schott Pharma.The authority level follows the approval matrix guideline defined by Schott Igar Glass.The authority level follows tasks and responsibilities given by direct superior accordance with the valid guideline.
Proven success in global communications roles, ideally within pharma/biotech or regulated industries; Experience in applied science communications is highly desirable.Proven experience working in a global, highly matrixed environment, collaborating across regions and functions and influencing cross-functional stakeholders.Fluency in German and English, both written and spoken. Reporting Relationship: Role that this position reports to: Director, Communications Business Partner CSL International Roles that report to this position: none What we offer Our benefit plan offers our employees numerous choices including such options as life insurance and retirement plan Up to two additional leave days for your personal wellbeing.
Main Roles & Responsibilities of the Contract Support Administrator Understand, anticipate and delivery customer (internal and external) needs while building effective relationships.Managing and operating site CMMS systemRaising and chasing of supplier orders including dealing with supplier queries.Input engineers time sheets onto the relevant systems.Compiling of Customer Weekly, Monthly and Annual Reports, and other reports as required to enable the Company to fulfil its contractual obligations.Produce quotations in the required format and in line with agreed process.Updating and uploading information to the client’s systems as required in a timely manner.Liaison with the operations team from engineer to director level.Raising of work orders in a timely and accurate manner and chasing old work orders to ensure closure.
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