- Merck & Co. (North Wales, PA)
- …is accountable for the delivery of all regulatory milestones for higher complexity products including assessment of the probability of regulatory success together ... of the CMC Regulatory Strategy Document for projects of increasing complexity .Lead development and execution of detailed, global regulatory submissions of INDs,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …objectives. This position manages new projects and projects of increased complexity including those involving 3rd party collaborators The position may manage ... stage projects. This position manages multiple assigned projects of increased complexity including post marketing projects and those involving 3rd party development.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disorders. Job Summary: Position leads statistical support for low to medium complexity studies including contributing to development of optimal study design, follow ... study report (CSR): Executes statistical activities for low to medium complexity studies including study design, protocol development, CRF review, SAP development,… more
- Merck & Co. (Rahway, NJ)
- …problems. Enable delivery of data-analytics projects and understand complexity /dependencies between multiple teams and platforms.Communicate intensively with other ... platform/competencies to comprehend new trends and methodologies within company ecosystem.Understand customer/stakeholders business needs/priorities and help build solutions that support our business goals.Establish and manage close relationship with… more
- Merck & Co. (North Wales, PA)
- …leadership, teamwork, and executive communication.Strong ability to manage complexity and prioritize multiple tasks.Strategic thinking, problem-solving, and ... analytical skills.Strong ability to motivate, coach, and inspire others.Deep understanding of US healthcare trends and policy issues and their impact on business opportunities.Knowledge of our Company's commercial, regulatory, and legal compliance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders. Summary Position leads statistical support for medium complexity studies including contributing to development of optimal study design, ... and clinical study report (CSR): Leads statistical activities for medium complexity studies including study design, protocol development, CRF review, SAP… more
- Genmab (Plainsboro, NJ)
- …of regional labeling (eg, JPI)Manages new projects and projects of increased complexity including those involving 3rd party collaborators Keep up to date with ... global labeling guidelines and regulations as they relate to the development/maintenance of labeling documents and advise the LWG accordinglyAdvise LWG on the content of labels in the same therapeutic class, competitor labeling and labeling trends, proposing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …NNI Business Solutions (NBS). At any time, this individual will support multiple high complexity projects within NBS. It is paramount to be able to remain nimble ... while driving key projects successfully, and providing the support needed to ensure strategic objectives and tight deadlines are met. Relationships This position reports to the Director, Strategic Advisor & Supplier Diversity Lead. Key stakeholders from within… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Summary Oversees typically a single non-pivotal trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory ... document. Collaborates as team member with AROs/CROs. Drafts development plans, protocol profiles, and sections of submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of instructions furnished in written, oral, or diagram.Ability to deal with complexity across the drug product, the associated manufacturing process, and the ... end-to-end supply chain process.Solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.Language: English#Li-JK1Legend Biotech is a proud equal opportunity/affirmative action employer… more
- Merck & Co. (Durham, NC)
- …product qualityExplains information and persuades others in straightforward and low complexity situations as a subject matter expertMakes decisions within guidelines ... and policies that impact own priorities and allocation of time to meet deadlinesEscalates potential cGMP or compliance issues effectively in a timely manner for proper resolution to ensure product quality PROJECT MANAGEMENT: Accountable for quality and/or… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to gain consensus for strategic initiatives and ideas, in the face of complexity or disagreement Utilizes and enhances procurement and sourcing systems and tools: ... Follows up on system usage and proactively ensures compliance to system Interfaces with the Novo Nordisk Corporate Procurement to promote optimal use of procurement systems and ensure NNIs involvement in global sourcing projects and related efforts Partners… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …market tactics/high impact results (based on metrics/ROI) Ability to manage complexity and work across competing priorities Strong knowledge of HCP engagement ... channels and regulatory considerations Content Planning, Execution, and follow-through skills Experience developing marketing content across a variety of channels Experience in implementation of personalized marketing tactics Data-driven mindset with… more
- Aequor (Thousand Oaks, CA)
- …Manages one or more cross-functional projects of medium to high complexity . Establishes and implements project management processes and methodologies to support ... the various program Core Teams, including subteams within the Combination Product Operations function, to ensure projects deliverables are completed on time and adhere to high quality standards.Scope includes a wide range of devices, such as; needle protection… more
- Merck & Co. (Durham, NC)
- …policies and objectives. Ensure the initial project tailoring is appropriate for the complexity and risk to accommodate the full scope of work. Provide the ... independent quality approval of key qualification/validation documentation such as policies, procedures, acceptance criteria, plans, protocols, specifications, reports and computerized system related changes to ensure compliance to company standards and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with customer journey mapping and optimization techniques Ability to manage complexity , including the leadership of work across competing priorities Strategic ... thinking and analytical skills, with the ability to translate insights into actionable marketing strategies to guide customer experiences Understanding of regulatory, compliance, and ethical considerations in engaging with healthcare providers and patients… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders. Summary Oversees one or more trials of medium to high complexity in design and geographic scope. Such trials could be pivotal for submission; ... Prepares clinical section of regulatory documents; Oversees management and performance of CRO; Participates in creation of developmental and regulatory strategy; Drafts protocol profiles and sections of key submission documents; Point of contact for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …stage projects. This position manages multiple assigned projects of increased complexity including post marketing projects and those involving 3rd party development. ... This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets (CCDS) for assigned products. This position drives/leads the maintenance of global labeling and associated documents (including… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …be both process/capability development for a relatively new functional group and high- complexity disease work to support critical strategic choices for the clinical ... program. The DAST Director will collaborate with the DAST Lead and core DAST membership to build out disease-focused resources and capabilities. The individual will be a key contributor to a unified Disease Area Strategy across the Oncology Portfolio and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …departmental collaborations. Work is escalated if outside of scope of role, and/or complexity .This position has strong knowledge of GMPs and GCPs and is compliant ... with domestic and foreign regulatory requirement but may seek support on such items from time to time.Has sufficient knowledge to identify critical issues or problems with projects and/or identification of issues which may compromise patient dosing or safety.… more
