102 Site Selection Jobs - Page 5

Sr Medical Research Associate POSITION PURPOSE: Senior Medical Research Associate is key resource personnel in Medical Affairs for managing and executing Phase IV studies (including Post marketing surveillance studies, Non-interventional studies (NIS), mandated Phase IV studies including interventional post-approval trials) activities across all business areas. He/She is responsible for all operational and quality aspects of the allocated studies in compliance with ICH-GCP, local regulations and within the agreed timelines and cost. YOUR TASKS AND RESPONSIBILITIES: As Individual contributor: To Coordinate all study activities like CRO selection, preparation of study documents for review, site selection and feasibility, update relevant tracking systems on an on-ging basis, implement quality checks especially for outsourced studies and manage clinical trial oversight, manage study budget and required resources, site monitoring, quality review and archival. The major responsibility includes on-time and on-budget completions in India. To have an oversight on CRO partners for outsourced studies by conducting oversight quality visits at sites if applicable, conduct regular meetings and seek regular updates on study progress. Organize Investigators meetings if applicable, conduct site feasibility visits and site initiation visits if applicable to ensure that the study staff are well trained and familiar with the protocol and study procedures. Responsible for the implementation and training of standardized processes within the study and according to organizational SOPs. Development of essential studies as per the local requirement and creating the essential documents like protocol, ICF etc with coordination with global/local team members. Ensures that essential documents meet the quality expectations of regulatory requirements in India and Bayer guidelines/SOPs. Reports and/or communication with Health Authority/IRB/Investigators and global/country study team, marketing/sales departments to update and share study progress, protocol, safety and other issues where necessary and submit annual-bi-annual report to regulatory teams in order to meet local requirements. To provide efficient and timely study updates to Manager Medical Operations. WHO YOU ARE: A Qualified pharmacy or science/life-science graduate/ postgraduate. Desirable previous experience of around 5 years in clinical research. Strong skills in managing stakeholders and good understanding of handling clinical trials in line with ICH-GCP and local regulations. Business Acumen displaying ability to operate cross-functionally Persistent in approach, drives objectives despite setbacks AdEopts an optimistic outlook Collaborates effectively, team player, team leader Inquisitive mindset, challenges status quo, proactive in approach.

The Regional Supply Project Leader is responsible for effective execution of all new product launches and supply chain improvements projects followed by M&ISC and SBS work process through cross-functional collaboration and project management. The scope of project activities may be country or regional and encompass a single business portfolio or multiple business portfolios with the overall objective to maximize business value growth, through the generation and delivery of a pipeline of new product launches and improvement ideas. The ideal candidate will be comfortable operating in a fast-paced environment, problem solving, possess an owner mindset, refined sense of urgency and enjoys collaborating with multiple businesses, functions, and geographies. This role can accommodate a flexible work arrangement allowing work from home a couple days per week. Roles & Responsibilities: Collaborate cross functionally to identify supply chain improvement opportunities. Identify and take action to mitigate supply risks, ensuring successful and effective new product launches as well as overall projects execution in compliance. Establish project expectations with key stakeholders and manage expectations with effective communication throughout the project, including expected project timeline, associated costs, and status. Define, execute, and maintain the project plan, timeline, stakeholder communication plan, and control plan for all assigned projects. Responsible for identifying savings in existing supply chains through optimization or waste reduction. Follow M&ISC or SBS working process on Design and Configuration of the supply network, getting Approval based on the Global Approval Matrix for all projects and align those to the regional supply chain for Implementation. Ensures definition or validation of the formulation & packaging strategy and overall supply chain network design, and completion of the site selection work process focused on high complexity projects (e.g. New Formulation Launches, Co-packs, SBS implementations of Active & Intermediate Source Change (A&IS) and Formulation & Packaging (F&P) Sourcing Evaluation projects, as well as other more complex supply chain projects generated by business needs). Represent Supply on the Innovation Management Network Team as needed, either as Extension & Improve Supply Program Leader (eSPL) or as Regional Product Launch Leader (RPLL). Represents the region on Pipeline Program teams. Represent Supply on Local Product Concept Teams. Represent new launch projects within the formulation and packaging 5-Years Supply Planning Process. Calculate new product launch costs and ensures cost assumptions are appropriately communicated to stakeholders. Offer project guidance and coaching to another Junior team member. Key to Success: Strong communication skills, verbal and written. Connect and integrate well with global and regional teams. Project Management mindset, attention to details. Ability to problem solve and troubleshoot issue resolution. Exhibit strong organization skills and ability to balance multiple initiatives at once, depending upon the complexity and job level. Dedication and drive to execute project plans. Ability to quickly learn new applications and systems. Ability to work and thrive in a team-oriented environment. Continuous innovation mindset. Developing options based on analytics and data. Ability to collaborate and work with diverse team members in different locations. Use influence and prioritization to build and execute plans. Create new opportunities and lead others to define a program and risks to implement an opportunity; lead others to embrace positive aspects of change and support their transition. Proactive in creating informal teams or networks of colleagues to generate ideas; work with and through others to consistently influence direction and activity of teams. Proactively seek to understand stakeholder deliverables and work to design interdependent work processes and standards, with clear understanding of tradeoffs and priorities. Determine the overall scope of actions with minimal coaching; seek comprehensive input and conduct exhaustive information search to develop a solution or plan forward. Deliver presentations or reports that distill complex ideas into clear results and proposals; communicate appropriately to influence internal and external audiences. Qualification & Education: Bachelor's Degree required ; preferred disciplines include Supply Chain, Operations, Engineering, Business, or another related field. ASCM (formerly APICS) CPIM Certification is a plus. Fluent in English 5+ years of relevant work experience in Supply Chain, Manufacturing, R&D, Operations, Business, or related field (OR) Master s / advanced graduate degree in a Supply Chain related field Preferred experience in Project Management . Project Management Professional Certification, Six Sigma Certification, and/or Lean Practitioner is a plus. Demonstrated proficiency in utilizing tools and processes for data analysis. SAP / APO / BW (or equivalent) experience preferred.