Boehringer Ingelheim Pharmaceuticals, Inc
Remote * (Ridgefield, CT 06877, USA)
Description: Responsible for the development of comprehensive trial and project Feasibility assessments for BI Phase I-IV studies and ensures recommendations are tactically feasible. In close alignment with internal stakeholders, identifies highly capable investigators/sites to meet study requirements and business needs. Applies expertise and uses systems and databases to improve efficiencies, integrity, quality, and the standardization and availability of data to ensure site selection and patient recruitment goals can be met. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to...
Jan 19, 2021
Description: Responsible for the development of comprehensive trial and project Feasibility assessments for BI Phase I-IV studies and ensures recommendations are tactically feasible. In close alignment with internal stakeholders, identifies highly capable investigators/sites to meet study requirements and business needs. Applies expertise and uses systems and databases to improve efficiencies, integrity, quality, and the standardization and availability of data to ensure site selection and patient recruitment goals can be met. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to...
Boehringer Ingelheim Pharmaceuticals, Inc
Remote * (Ridgefield, CT 06877, USA)
Description: Executes medical writing activities for projects in accordance with applicable regulatory regulations and Boehringer-Ingelheim requirements under the supervision of the Sr. Associate Director or Director of Medical Writing. Assumes primary responsibility for preparation of documents supporting major regulatory submissions and other documents as assigned, and assists the manager in coordinating and evaluating the activities of other contributors (including contract writers and CROs). Participates on relevant project teams and task forces, provides guidance on issues related to document preparation and production, and project- or therapeutic area-specific guidance related to content and organization of specific documents. Responsible to develop associates (development plans, training, coaching and mentoring, as appropriate). As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients...
Jan 19, 2021
Description: Executes medical writing activities for projects in accordance with applicable regulatory regulations and Boehringer-Ingelheim requirements under the supervision of the Sr. Associate Director or Director of Medical Writing. Assumes primary responsibility for preparation of documents supporting major regulatory submissions and other documents as assigned, and assists the manager in coordinating and evaluating the activities of other contributors (including contract writers and CROs). Participates on relevant project teams and task forces, provides guidance on issues related to document preparation and production, and project- or therapeutic area-specific guidance related to content and organization of specific documents. Responsible to develop associates (development plans, training, coaching and mentoring, as appropriate). As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients...
Boehringer Ingelheim
Remote * (Ridgefield, CT 06877, USA)
Description: For assigned development projects and US marketed products, provide experienced US regulatory leadership to the global and US cross-functional teams. Provide US strategic regulatory guidance to facilitate efficient and compliant drug development and product maintenance. Act as primary company liaison with the US Food and Drug Administration Provide analysis, advice and guidance on US regulatory strategies. Provide expertise on regulatory standards and departmental policies Utilize resources consistent with the overall goals and objectives of the (G) RA department. Maintain current expertise on developments in the assigned therapeutic area from the global regulatory, legislative, scientific, medical, pharmaceutical, pharmacovigilance, market access and commercial perspective. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence...
Jan 19, 2021
Description: For assigned development projects and US marketed products, provide experienced US regulatory leadership to the global and US cross-functional teams. Provide US strategic regulatory guidance to facilitate efficient and compliant drug development and product maintenance. Act as primary company liaison with the US Food and Drug Administration Provide analysis, advice and guidance on US regulatory strategies. Provide expertise on regulatory standards and departmental policies Utilize resources consistent with the overall goals and objectives of the (G) RA department. Maintain current expertise on developments in the assigned therapeutic area from the global regulatory, legislative, scientific, medical, pharmaceutical, pharmacovigilance, market access and commercial perspective. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence...
Company Description WOONGJIN, Inc. is looking for a Project Manager for a well-known client located in Ridgefield Park, NJ. Our Mission WOONGJIN, Inc. is a rapidly growing team who provides a range of unique, exceptional, and enhanced services to our clients. We have a strong moral code that includes the service of goodness without expectations of reward. We are motivated by the sense of responsibility and servant leadership. Job Description Create & deliver project management deliverables such as project plan, kick-off/mid/closing reports & status/weekly reports, also support project members to draft project execution deliverables Lead project management cycle from proposal, start up, resource selection, team building/on boarding, implementation, and the rollout of systems or apps Design communications to project team members and stakeholders on progress, issues, and risks to ensure project success and customer satisfaction. Manage project scope,...
Jan 19, 2021
Company Description WOONGJIN, Inc. is looking for a Project Manager for a well-known client located in Ridgefield Park, NJ. Our Mission WOONGJIN, Inc. is a rapidly growing team who provides a range of unique, exceptional, and enhanced services to our clients. We have a strong moral code that includes the service of goodness without expectations of reward. We are motivated by the sense of responsibility and servant leadership. Job Description Create & deliver project management deliverables such as project plan, kick-off/mid/closing reports & status/weekly reports, also support project members to draft project execution deliverables Lead project management cycle from proposal, start up, resource selection, team building/on boarding, implementation, and the rollout of systems or apps Design communications to project team members and stakeholders on progress, issues, and risks to ensure project success and customer satisfaction. Manage project scope,...
Boehringer Ingelheim
Remote * (Ridgefield, CT 06877, USA)
Clinical Scientist / Associate Director, Clinical Operations - Oncology (Remote) ***Candidate will be hired commensurate with the level and experience*** Clinical Scientist Description: Accountable for operational management of clinical trials: planning, set up, conduct and reporting. Maintains oversight, ensures feasibility of trial plans, and pro-actively assesses and mitigates risks. Enforces AAI (Agility, Accountability, Intrapreneurship) approach and skills in the trial team and trial management. As clinical trial manager (CTM), accountable for the operational management of the regional/local component of a clinical trial. Level of oversight assures achievement of trial recruitment commitment, timelines, budget and internal/external quality standards. Communicates trial status to stakeholders/senior management on a regular basis, escalating issues as appropriate. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development...
Jan 18, 2021
Clinical Scientist / Associate Director, Clinical Operations - Oncology (Remote) ***Candidate will be hired commensurate with the level and experience*** Clinical Scientist Description: Accountable for operational management of clinical trials: planning, set up, conduct and reporting. Maintains oversight, ensures feasibility of trial plans, and pro-actively assesses and mitigates risks. Enforces AAI (Agility, Accountability, Intrapreneurship) approach and skills in the trial team and trial management. As clinical trial manager (CTM), accountable for the operational management of the regional/local component of a clinical trial. Level of oversight assures achievement of trial recruitment commitment, timelines, budget and internal/external quality standards. Communicates trial status to stakeholders/senior management on a regular basis, escalating issues as appropriate. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development...
Boehringer Ingelheim
Remote * (Ridgefield, CT 06877, USA)
Associate Director / Senior Associate Director, Clinical Operations - Oncology (Remote) ***Candidate will be hired commensurate with the level and experience*** Associate Director, Clinical Operations - Oncology Description: Accountable for operational management of clinical trials: planning, set up, conduct and reporting. As Leader of the Trial Team, maintains oversight, ensures feasibility of trial plans, and pro-actively assesses and mitigates risks. Enforces AAI (Agility, Accountability, Intrapreneurship) approach and skills in the trial team and trial management. May serve as Clinical Trial Manager (OPU role) and/or Clinical Trial Leader (global role). May mentor more junior CTMs. Communicates trial status to stakeholders/senior management on a regular basis, escalating issues as appropriate. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global...
Jan 17, 2021
Associate Director / Senior Associate Director, Clinical Operations - Oncology (Remote) ***Candidate will be hired commensurate with the level and experience*** Associate Director, Clinical Operations - Oncology Description: Accountable for operational management of clinical trials: planning, set up, conduct and reporting. As Leader of the Trial Team, maintains oversight, ensures feasibility of trial plans, and pro-actively assesses and mitigates risks. Enforces AAI (Agility, Accountability, Intrapreneurship) approach and skills in the trial team and trial management. May serve as Clinical Trial Manager (OPU role) and/or Clinical Trial Leader (global role). May mentor more junior CTMs. Communicates trial status to stakeholders/senior management on a regular basis, escalating issues as appropriate. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global...
