- Eisai, Inc (NJ)
- …this is your profile, we want to hear from you. Job Summary The Senior Manager, Medical Writing will be the designated Lead Medical Writer for approximately ... protocol amendments often acting as the compound leadLead project management for medical writing deliverable by defining milestones, managing budget, resources… more
- Merck & Co. (North Wales, PA)
- …includes, but is not limited to: Reporting to Senior Management of the Medical Device and Combination Product (MDCP) Quality Assurance Operations team, the Associate ... Director Quality Engineering & Quality Assurance is responsible for...Quality Assurance is responsible for independent compliance support of Medical Devices including the device constituent part of Combination… more
- Merck & Co. (North Wales, PA)
- …IS A HYBRID ROLE. AN ONSITE PRESENCE IS REQUIRED The Global Medical Information (GMI) Scientists for Oncology, with their advanced scientific background (PharmD, ... are resources within their therapeutic area for the global core functions of Medical Information (eg, customizing medical information letters to respond to US… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and amendmentsLead document review and coordination for the protocol and amendments. Additional medical writing tasks may involve ICF, CRF guidelines, IB and ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Eisai, Inc (Nutley, NJ)
- At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care ... efficacy, and assess benefits, risks, and the economic consequences associated with medical technologies. If you have a passion for health economic modeling to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective programThis Clinical Science (CS) Group Lead will ... CS Asset Leads who are managing a team of clinical scientists for the writing of protocols / amendments and associated documents ( writing of ICF, DM… more
- Eisai, Inc (Nutley, NJ)
- At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care ... ability to present clear instruction/direction.Analytical and problem-solving capabilities.Strong scientific writing and presentation skills.IND123#LI-MG1Eisai is an equal opportunity employer… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …documents (eg, response to HAs, briefing book, etc.) in conjunction with Medical Writing - Leads scientific components of IM (Investigators Meeting) and ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... and accelerated worldwide product submissions and approvalsAuthors or initiates writing of global standard operating procedures for statistical programming practice,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... and guidelines, reviews and provides written assessments of relevant medical topics, and supports PV Operations' medical ...and relevant team members.Reports and Submissions: May contribute to writing minor safety sections of the NDA, CSR, and… more
- Insmed Incorporated (Bridgewater, NJ)
- …New York™, and Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director of Development Quality Assurance, the Senior Director of ... other related activities performed by Drug Safety & Pharmacovigilance and Medical /Clinical Departments. The incumbent will provide support and promote collaboration… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …implementation of sourcing strategies for a specific set of R&D categories (CRO, Medical Writing , BDM, etc..). Builds strategic plans for specific categories ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... and represents global function on study and project teamsProduces independent writing for publications and regulatory documentsServes as a specialist in PK-PD… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... accelerated worldwide product submissions and approvals. Authors or initiates writing of global standard operating procedures for statistical programming practice,… more
- Insmed Incorporated (Bridgewater, NJ)
- …study design and documentation as needed.Contribute to regulatory document writing (eg IB, IND, Integrated Summary of Immunogenicity).Engage in scientific ... pet, legal, and supplemental life insuranceFlexible spending accounts for medical and dependent careAccident and Hospital Indemnity insuranceEmployee Assistance… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... Health Authorities globally by providing input for the interaction or by writing the interaction document. May participate in meeting or teleconferences with Health… more
- Merck & Co. (North Wales, PA)
- …medical protocol deviations in collaborations with the Clinical Director .Other responsibilities include: Collaborating cross-functionally in the development of ... This may include:Serving as the lead clinical scientist on a clinical trial team.Leading medical monitoring team in review and interpretation of clinical data/… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and amendments.Lead document review & coordination for the protocol and amendments. Additional medical writing tasks may involve ICF, CRF guidelines, IB and ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Contracting Operations and Reimbursement (PCOR) Account Management, the SME for Medical Review Committee, Compliance, Legal, Personal Promotion, and other HCP ... for use by downstream programs/users. Relationships This role reports to the Director of Master Data Management within the Data Strategy and Execution Master/Data… more
- Novo Nordisk Inc. (Durham, NC)
- …the world, driving the stability portfolio for all products, and writing and maintaining regulatory documentation. Relationships Director . Essential Functions ... 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases,...successful execution of support to the productions Coordinate with Director , Bulk, Pack, QC & EM & other teams… more
