- Merck & Co. (North Wales, PA)
- …in the Research & Division organization of our company.- Position Description/Summary: The GPAM Associate Director , Project Manager, is a core member of ... & Development pipeline and realize its full potential. The Associate Director is expected to provide project management leadership and drive cross-functional… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …company's growth, thereby accomplishing corporate goals.ResponsibilitiesDevelop and implement US regulatory strategy for assigned project (s).Strategize and plan ... with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development...will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product ... labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an...may serve as an ad hoc member of Global Project Team (GPT) to address labeling issues for late… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Associate Director , Global Clinical Operations (GCO) Procedural Ownership and ... processes, guidelines, and policies, and meet applicable ICH and GCP standards. The Associate Director will also be responsible for the creation, management, and… more
- Merck & Co. (Rahway, NJ)
- …of decision-making at our company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas.This Associate ... on a continuous basis in decision making and driving pipeline impact. The Associate Director will perform job duties independently with minimal supervision… more
- Merck & Co. (Rahway, NJ)
- …Quantitative Pharmacology and Pharmacometrics - Immune/Oncology (QP2-IO) team in the role of Associate Director QP2-IO team is part of the Global Clinical ... of drug development and effective communication skills. As a subject matter expert, the Associate Director within the QP2-IO Group will work closely with teams… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …an equal opportunity employer including veterans and people with disabilities.SummaryThe Associate Director will be responsible for developing and implementing ... in due diligence activities and represents global function on study and project teamsProduces independent writing for publications & regulatory documentsServes… more
- Merck & Co. (North Wales, PA)
- Job DescriptionWe are currently recruiting for the position of Associate Director , US Oncology - Hematology Scientific Strategy. This talented individual will ... a matrix organization while leading through influence.Strong problem solving, project management, and written/ verbal communication skills.Experienced in bringing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for a living. Are you ready to make a difference? The Position The Associate Director , Research Partnerships (RP) is responsible for developing and executing ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...alignment with the Evidence Generation Plan (EGP). Externally, the Associate Director RP will be the lead… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Associate Director US Oncology Marketing Digital Engagement will direct the identification, design, execution, oversight, and optimization of ... teamworkStrong knowledge of marketing standardsConstituency management across organizational linesExcellent project management skills-Strong communication, presentation, and negotiation skillsAgency management… more
- Merck & Co. (North Wales, PA)
- …innovative medicines that help people around the globe. We are currently recruiting for Associate Director , US Marketing, HCP Strategy for HIV. Our company has ... to drive and align on decisions, including field sales, marketing operations, Legal, Regulatory , Medical, etc. Our US marketing team has adopted an Agile operating… more
- Insmed Incorporated (San Diego, CA)
- …to the Executive Director of Program Management, the Associate Director , Program Management supports the cross-functional drug development ... creation, and implementation of high quality, global, coordinated cross-functional project plans for products in accordance with the program...in accordance with the program strategy. In addition, the Associate Director of PM may be asked… more
- Eisai, Inc (Raleigh, NC)
- …and approve relevant technical documents, such as change controls, regulatory submissions, deviations, validations, method transfers, APRs, etc. as ... which must be in a people management position.Prior contract manufacturing project management experience is highly preferred. Prior experience with manufacturing… more
- Merck & Co. (Rahway, NJ)
- …bring analytical representation and expertise to project teams and support regulatory filings (eg, INDs/IMPDs and BLAs).-The Director selects, trains, and ... Job DescriptionThe Director of Biologics Potency in Analytical Research &...responsible for a team of approximately 10-15 senior and associate level scientists in Rahway, New Jersey. -The position… more
- Merck & Co. (North Wales, PA)
- …medical/legal review processes) including experience including bringing materials through legal, regulatory , and clinical review Strong project management skills ... as demonstrated by prioritizing activities, using resources optimally, establishing appropriate deadlines and ensuring on-time delivery Experience influencing without direct authority, navigating complex or matrix organizations and working successfully with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …equal opportunity employer including veterans and people with disabilities. Summary The Associate Director , Clinical Data Standards, is responsible for the ... and enforcement of data standards, demonstrated knowledge of industry standards related regulatory requirements (CDISC), FDA & ICH, PMDA, EU & ICH, CRP and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders.Summary The Associate Director , RACMC, is responsible for the regulatory CMC (Chemistry, Manufacturing ... on Component teams and/or serve as G-RACMC lead or regional submission lead. Provide regulatory guidance and strategy to CMC sub-team and G-RA teams along with other… more
- Merck & Co. (North Wales, PA)
- …cycle of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.-Specifically, the Director may be ... statistics, and manufacturing to manage clinical development projects; andAssist the Senior Director , Executive Director , and/or Associate Vice President in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for patients who are likely to benefit from our therapeutics. Contributes to CDx project teams for the diagnostic, under the direction of the Global Program Teams ... Science Leads, Clinical Biomarker Leads, Biosample Operations, Clinical Leads and Regulatory Liaisons to ensure successful implementation of CDx and data… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …delivery of medical coding for clinical trials, clinical development, and regulatory submissions. Develops and proposes strategies for medical coding and coding ... Direction, and Strategy:Provides medical coding expertise and guidance to the project team regarding the medical coding activities and deliverables. Ensures… more
