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High Profile Pharmaceutical company with recent FDA one of a kind approval is hiring a Senior Manager of Regulatory Affairs CMC Reporting to the director technical writing of RA CMC of Regulatory Affairs, the Senior Manager of Regulatory Affairs, CMC will be responsible for the preparation of high quality regulatory submission content focusing on CMC to support global clinical development, registration, and product life cycle management in accordance to regulatory requirements and guidelines.....


Global Pharmaceutical company is hiring an Executive Director to head up their Renal Medical Affairs Division this Executive role will report into the Executive Vice President of Medical Affairs and spear head the high profil department must be Nephrologist with at least 3 years of medical affairs experience Renal Cardio Medical Head (Executive Director) The Renal Cardio Medical Head is a member of the Renal-Cardio Therapeutic Area (RCTA) leadership team and leads the Renal Cardio Core Medical


Leading Global Pharmaceutical company with office in Waltham Massachusetts Manager, Health Economics & Outcomes Research (HEOR) Position Summary: The Manager for Health Economics & Outcomes Research (HEOR), will be responsible for supporting HEOR activities for company's products. This individual will contribute to evidence generation, development of strategy, data analysis and dissemination and support the HEOR Senior team members (Directors, Senior Directors).....


Director of Clinical Development Cardio This global Pharmaceutical company is the worldwide biologics research and development leader. Here, you’ll have the opportunity to make a difference in people’s lives every day. As one of the world’s premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease. As a Director, Clinical Development in Gaithersburg MD or Cambridge UK, you’ll play a pivotal role in....


Pharmaceutical client in NYC hiring two Clinical Research Study Managers for their Global Trials The Clinical Research Study Leader (CRSL) will provide leadership to global Study Management Teams responsible for delivering First in Man, Proof of Concept through to Phase 3 registration studies in various indications. The CRSL will manage a number of studies, either for a single indication or across different indications. The CRSL is accountable for the strategic and tactical study activities,....

- Cambridge, MA

Global Company is hiring a Senior Leader Clinical Operations Biotechnology company specializing in the detailed structural analysis of complex drugs and is headquartered in Cambridge, MA. Company is applying its technology to the development of generic versions of complex drugs, biosimilar and potentially interchangeable biologics, and to the discovery and development of novel therapeutics for oncology and autoimmune indications This position will be responsible for initiating and leading....


The Senior Manager, Clinical Development CNS will participate in internal process improvement activities within R&D and Clinical Development. Main Areas of Responsibilities supports the Clinical Program Lead and Clin.Sci. Lead in the development of the Clinical Development Plan and associated clinical trial content (e.g., protocols, IBs/IDFUs, CRFs, CSRs, regulatory submissions and publications) by contributing to scientific/clinical information aligned with the strategy. key Clinical....


PHARMACEUTICAL COMPANY: focused on cns and GI and anti-infective The growth of this Corporation has created a unique opportunity for a variety of positions in Northern New Jersey, accommodating staff in Clinical Operations, Data Management, Biostatistics, Clinical SAS Programming and Regulatory. The Clinical Trials Manager will be able to organize and facilitate the overall planning, coordination and general performance of clinical trials that support the Clinical Development Plan for Clinical


Top Tier Pharmaceutical company (with focus in RESPIRATORY, CNS, Diabetes, Cardio, GI and more) in Madison, NJ is looking for three Clinical Trials Manager Consultants for Clinical Trials Group This is a one year contract and can continue for up to 4 years (1099 or w-2)SummaryParticipate in all aspects of clinical development and study management under the direction of the Director, or designee, which includes providing scientific, and/or logistical support to planned and ongoing trials CTM –....


Top Tier Pharmaceutical company (with focus in Cardio, respiratory, CNS, Psych and more) in Madison, NJ is looking for a new Director, Clinical Development for to add to this growing team!The Director Clinical Development will report directly to the Vice President and is responsible for the scientific, strategic, therapeutic, and operational management of programs to evaluate, register, and market pharmaceutical agents. Lead and direct study programs, activities, and teams for one or more....


Global Pharmaceutical Leader is looking for consultant (all levels) Clinical Managers for their growing Clinical Development team Accountable for leading the operational study team, which is responsible for the execution and delivery of quality studies, including in-process quality control activities (e.g. quality checks and balances to ensure inspection readiness, enrollment, metrics, milestones, timelines and budget). This position requires advanced knowledge of the functional disciplines....

- Cranford, NJ

Global Pharmaceutical company is hiring a \ for their growing company. Our Clinical Trainer is responsible for identifying and implementing Clinical Development staff training needs. They may benchmark Clinical SOPs and insure SOP training is completed and up to date. The Clinical Operations Trainer may also periodically co-monitor and evaluate staff performance and provide guidance for performance, improvement and adherence to FDA and SOP requirements. They may liaise with US and Taiwan....


High Profile need for Global Pharmaceutical company in NJ Assoc VP, Toxicology company is a bold, global pharmaceutical company and a leader in a new industry Position Overview The Non-Clinical and Translational Sciences organization at Company is seeking an Associate Vice President to lead our department of experienced toxicology/pathology scientists. This role has responsibility for non-clinical safety evaluation for all company pharmaceutical products, in research, development or on the....

- Cambridge, MA

Exciting science being performed at this Pharmaceutical company. Looking to hire two Clinical Operations Leaders under the direction of the New Vice President Clinical.he Clinical Operation Lead is responsible for developing operational strategy for one or more clinical studies, and leading the cross functional Study Management Team to align and deliver on study goals of data quality, timelines, budget and GCP compliance in support of overall program level plans. Responsibilities: The Clinical


Pharmaceutical company is hiring an Associate Director Medical Writing for their Waltham Massachusetts location.We are a leader in innovative medicines that address the unmet needs and challenges of people living with debilitating diseases. As a fully integrated global biopharmaceutical company, we apply our scientific expertise, proprietary technologies, and global resources to develop products that are designed to make a meaningful difference in the way patients manage their disease. Our....


GLOBAL PHARMACEUTICAL COMPANY IS HIRING A HEAD OF MEDICAL AFFAIRS FOR RENAL Renal Cardio Medical Head (Executive Director) The Renal Cardio Medical Head is a member of the Renal-Cardio Therapeutic Area (RCTA) leadership team and leads the Renal Cardio Core Medical Team. The position can be either a Senior Director or Executive Director based upon the individual's experience. The Medical Lead is knowledgeable of the actions of regulatory bodies, in particular, knowledge of the FDA. He/She has....


Clinical Research Physician Global Oncology Pharmaceutical company is expanding and looking to add an MD Strong base salary and benefits and long term incentives POSITION OBJECTIVE: The Clinical Research Physician will be dedicated to providing a leadership role on a matrix team dedicated to stage appropriate clinical development of multiple innovative compounds. He or she will lead the development of clinical strategies for compounds and drive their successful implementation. Essential Job....


Clinical Research Physician Global Oncology Pharmaceutical company is expanding and looking to add an MD Strong base salary and benefits and long term incentives POSITION OBJECTIVE: The Clinical Research Physician will be dedicated to providing a leadership role on a matrix team dedicated to stage appropriate clinical development of multiple innovative compounds. He or she will lead the development of clinical strategies for compounds and drive their successful implementation. Essential Job....


Global Pharmaceutical company is looking to hire a Director of Medical Safety Irvine, CaliforniaMD (US or foreign is acceptable)2 years PV/Risk Mgt. experience is acceptableMust have aggregate reporting and clinical safety experiencewill relocate and offer very competitive salary and benefitsDirector Medical Safety We are aa bold, global pharmaceutical company and a leader in a new industry model - Growth Pharma. We are focused on developing, manufacturing and commercializing branded....


POSITION SUMMARY: Independently responsible for the efficient and thorough investigation of process deviations and customer complaints, determination of root cause, and initiation of corrective/preventative actions designed to adequately address and correct the Quality related deficiencies identified during the investigation process. Responsible to provide proactive corrections based on noted trends to minimize the potential for repeat incidents that may lead to, or result in, the issuance of....

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