- Merck & Co. (North Wales, PA)
- …including content authoring, review and finalization, and feed to the Submissions Assembly team . The Business Operations Lead should be able to understand the ... ONSITE 3 DAYS PER WEEK)The Submissions Content Source Management Business Operations Lead is expected to understand the end-to-end regulatory submission process. The… more
- Merck & Co. (North Wales, PA)
- Job Description Director, US Oncology Marketing, INT Treatment Site Strategy & Execution Lead The US Oncology business within our company is a growing and dynamic ... have an exciting opportunity to join our dynamic marketing team focusing on intismeran autogene, a cutting-edge individualized neoantigen...US Oncology Marketing, INT Treatment Site Strategy & Execution Lead . This role will be pivotal in the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …your potential with us? The Position This job exists to assist in executive support for the delivery of alternative business models across Finance and Operations and ... Alternative Model Execution Management (AMEM). This role in the team will be to drive projects and tasks related...be to drive projects and tasks related to executive support of alternative business models. Moreover, the position will… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …subject matter expert for interactions with regulatory agencies (FDA, EMA, etc.); support or lead preparation of regulatory submissions (eg, pre-IND, IND, ... Director of Toxicology as part of the Clinical Development team based in Philadelphia, PA or Somerset, NJ. Role...highly experienced and strategic Senior Director of Toxicology to lead and oversee all nonclinical safety assessment activities for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department Novo Nordisk's Market Access and Public Affairs team engages diverse stakeholders across political and healthcare landscapes to forge solutions ... across Market Access & Public Affairs, as well as team representatives from Marketing & Patient Solutions, Executive Office...MA LT to ensure alternative models align with and support broader market access objectives Collaborates with the MA… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …on insights from the marketplace. This role may also lead the Core Medical Team , Project Team (co-chair), and National Advisory Board meetings for a ... for select clinical trials, in collaboration with Clinical Director and Clinical Operations lead Support investigator meetings Serve on Clinical Trial Strategy … more
- Merck & Co. (North Wales, PA)
- …at local, regional and global levels to enable value-driven decision making. You will lead and coach a team of market research professionals (both US based ... responsibilities include and are not limited to the following: Lead a team of market research professionals...time zones and geographies. Mentor and develop junior analysts; support ongoing growth of the team . -… more
- Merck & Co. (North Wales, PA)
- …for maintaining appropriate levels of knowledge and skill in order to effectively lead and support GCP inspections, worldwide.- Under the guidance of the ... Regulatory Health Authority inspection, in conjunction with the applicable Cross-Functional Team .CAPA Management Support :Ensures that all actions and commitments… more
- Merck & Co. (North Wales, PA)
- …Responsibilities :Serves as a statistical lead in project teams. Lead , develops, coordinates, and provides biostatistical support for related drug/vaccine ... written reports to effectively communicate results of clinical trials to the project team , our Company's Management, regulatory agencies, or individual… more
- Merck & Co. (North Wales, PA)
- …pre-launch and launch milestones. Key responsibilities for the HCP Strategy role include:- Lead physician strategy development and support the Director of HCP ... that extend and improve the lives of patients worldwide. Our team of dauntless, forward-thinking individuals achieves this through an unwavering commitment… more
- Merck & Co. (North Wales, PA)
- …of action plans that shape value frameworks and other policies impacting value assessment. As a Team lead , to build a strong high performing team and coach ... will be a member of the GMAx Pharma leadership team and will lead a team...Sustainable Access Solutions. The role requires outstanding leadership to support timely, broad, and sustainable access to our Ophthalmology… more
- Parexel (Trenton, NJ)
- If you are passionate about regulatory affairs and project management, and are looking for a challenging and rewarding opportunity, we would love to hear from you! ... Join our dynamic team at Parexel, where we are committed to partnering...are currently seeking a dedicated and detail-oriented **Regulatory CMC Project Manager** to join a growing, dedicated client partnership… more
- Skanska (Conshohocken, PA)
- Skanska is searching for a dynamic Superintendent 2 ( Project Lead ). This is a great opportunity to start a career with a company that builds things that matter ... and values its team . We are proud to share our culture of... and drive our D&I efforts. The Superintendent 2 ( Project Lead ) is responsible for field operations… more
- Parexel (Trenton, NJ)
- …medical affairs with innovative solutions. We are seeking a dynamic and experienced Data Management Lead to join our team . If you have a passion for clinical ... **Job Title:** Data Management Lead (Medical Affairs) - Oncology **Location:** Fully Remote...research, strong project management skills, and a knack for data management,… more
- Organon & Co. (Plymouth Meeting, PA)
- …Medicine and Early Development (TMED). As part of the Non-Clinical Development (NCD) team , the Non-Clinical Safety Assessment Lead will be responsible for ... project representatives on asset development teams (ADTs) to support the R&D pipeline programs. Management responsibilities include coaching, professional and… more
- Parexel (Trenton, NJ)
- …or out of scope requests, and suggest possible resolution options. + Attend or lead project team meetings as required. Mediate conflict or disagreement, ... and clients to set and meet internal/external deliverable timelines, project leadership, and training and support of...to Parexel or client guidelines/SOPs. Distribute final documents to project team and client. + Identify any… more
- Organon & Co. (Plymouth Meeting, PA)
- … support of project execution. The Associate Principal Scientist may also support project team goals and organizational initiatives, on an as needed ... Lead development and execution of global product and project regulatory strategy(ies) by ensuring robust assessment of CMC...leadership, communication, interpersonal and negotiating skills.? + Ability to lead a team of direct or matrixed… more
- Parexel (Trenton, NJ)
- …along with other stakeholders. Working as Subject Matter Experts (SMEs) + Assisting the Project Lead /Functional Lead for audits and inspections + Provides ... inputs for process improvements + Works closely with Project Lead /Functional Lead for process...Information (DSCI) + Coordinate safety activities between Drug Safety Unit/ team and internal and external partners + Conduct/ support… more
- Parexel (Trenton, NJ)
- …associated with clinical research. The Senior Medical Writer may operate as the project lead writer/submission coordinator and primary client contact to manage ... submission. ** Project Management** + Operate as the project lead writer/submission coordinator and primary client...team members. Monitor the progress of each individual project task and assess the overall program. + Ensure… more
- Organon & Co. (Plymouth Meeting, PA)
- …plans or, for mature or commercial assets, LCM plans. + Participate in or lead ADT sub- team meetings, as appropriate. + Responsible for the design, execution ... **Job Description** **The** **Position** The Director, Clinical Pharmacology Lead will be responsible for contributing and/or devising the clinical pharmacology… more
