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We are currently recruiting for a NASH Medical Director, Medical Affairs within Global Medical Affairs (GMA) and the Chief Medical Office (CMO). Working under the leadership of the Global Therapeutic Area Head, this role develops a comprehensive medical strategy for several products in development to treat Non-Alcoholic Steatohepatitis (NASH). They will work closely with Clinical Development colleagues within Research & Development as well as colleagues within Global Evidence & Value....


Position Overview Plans, directs, and executes product formulation and process development activities in support of development of new products intended for clinical trials and commercialization with focus solid and liquid dosage forms including immediate and controlled/modified release systems. Conducts research in the area of formulation sciences in support of innovative product development both for new chemical entities and life-cycle management of marketed products. Experience in the....


Medical Affairs – Fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. In this highly visible leadership role in Medical Affairs, you will work closely with a cross-functional group that includes....


Position Overview Provide analytical expertise and leadership in the development of drug substances and pharmaceutical products from early development through commercialization. Plan analytical research and development activities, devise strategies for achieving project goals and independently manage CMC timelines. Make pivotal contributions to drug product development strategy at project team level. Independently manage multiple projects and ensure timely delivery of all deliverables to meet....


POSITION SUMMARY The Analytical Instrumentation Manager will be responsible for the management of daily activities in support of all analytical equipment in Quality Control. The manager will assure that activities associated with the testing, release and results reporting of materials, products and components meet established and expected quality, Data Integrity requirements, regulatory and customer requirements. The Manager will regularly interact with departments on site and at a corporate....


Medical Affairs – Fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. In this highly visible leadership role in Medical Affairs, you will work closely with a cross-functional group that includes....


Education/ExperienceBS in life sciences or related field At least 2 years experience in clinical researchKnowledge of FDA regulations Prior Study Start-Up experience preferredAdvanced skills in Microsoft Word, Microsoft PowerPoint, Microsoft Excel, Microsoft Outlook Experience with Adobe Acrobat Professional and Microsoft Access a plusPresentation Delivery ResponsibilitiesExecute study start-up for assigned protocols within company timelines by identifying clinical team needs, Oversee Site....


POSITION OBJECTIVE: Responsible for leading the CMC (Chemistry, Manufacturing and Controls) regulatory function, the Senior Manager, Regulatory CMC will collaborate cross-functionally to develop the CMC regulatory strategy, provide guidance to broader CMC functions, and drive CMC regulatory filing(s). Working collaboratively with senior leadership to develop CMC regulatory strategies for one or more investigational and/or commercial products this position will lead the preparation and filing....


This position entails development of submissions in conjunction with other BDI Surgery departments, requiring working knowledge of products under review and of relevant regulations and guidance documents. Also, this position is responsible for writing, supporting, and assisting in gaining approval of product registrations and other submissions to International Business Centers. Qualifications: Bachelors's degree required (healthcare industry) 5-7 years of international regulatory experience....


Looking for candidates with regulatory affairs experience supporting R&D IVD, leading RA projects for new product developments Regulatory Affairs Specialist is responsible and accountable for developing and executing sound strategies for regulatory submissions and registrations for complex new product development projects. This position interfaces with multiple projects and functional teams with limited oversight, provides instruction, guidance, and regulatory interpretations to functional

- Aurora, IL

Responsible for meeting customer requirements associated with the production of Medical Devices beginning with receipt of an order, specifying raw material, and processing to the shipment and documentation of finished goods. Supports the development of internal systems and procedures to meet all customer specific, ISO 13485, and FDA 820/GMP requirements. Responsible for all monitoring and measurement devices. ESSENTIAL FUNCTIONS: · Builds, manages, and sustains a team of technical quality....


Overview: The Surgical Regulatory Affairs Sr Manager handles all regulatory development aspects of surgical devices. The incumbent participates on the product development team to provide regulatory guidance for surgical devices assigned. They also manage relevant regulatory strategy components and interactions with Regulatory Authorities for their assigned surgical products and may perform due diligence efforts on new product opportunities. Responsibilities: Responsibilities may include but....


Preferred Qualifications: · Clinical experience in or outside the US · Infectious Disease training with clinical and/or research background. · Knowledge of vaccine trial design and marketing issues. · The ideal candidate would be someone recognized by other vaccine experts as being expert in vaccinology or a related discipline. An acceptable candidate will have achieved recognition as highly experienced in relevant matters, e.g. infectious diseases, public health, clinical trials, etc. · The....

- New Brunswick, NJ

Our client is a leading global manufacturer of specialty chemicals used in a wide variety of consumer and industrial applications. We are conducting a search for a Regulatory Manager for their expending business headquartered in the New Brunswick, NJ area. Reporting to the Vice President of R&D this individual will be responsible for managing the PSRA group plus developing and implementing their regulatory compliance strategy for their worldwide operations. This will include:Implementing....


The position is responsible for planning and preparing complex medical device regulatory submission documents for US, Canada, and EU regulatory filings. Provides support for other global regulatory filings. Utilizing detailed, in-depth understanding of medical device regulation leads anticipates in goal regulatory teams, interprets regulations, and provides regulatory guidance. Support management with regulatory programs planning and implementations of departmental strategies and policies.


This unique opportunity reporting to the Vice President, Clinical Development will have a significant role in developing life transforming therapeutics for patients with rare diseases. Looking for a capable, insightful, practical, experienced and skilled physician leader to help plan, develop, execute and analyze clinical study programs in rare bone diseases. The best candidate can manage appropriate protocol development, endpoint development and effective reporting of results, adequate....

- Waltham, MA

Medical director - new products (depending on experience – may be senior or executive position) Reporting to VP & Head of Medical Affairs NA Staff responsibility Potentially yes Employment type Full time Purpose As a member of the NA medical affairs team this person will provide state of the art medical expertise and medical leadership for New Products Essential Responsibilities Lead the NA medical strategy and provide medical leadership and contribution for New ProductsProvide subject....

- King of Prussia, PA

The Senior Product Safety Specialist, working closely with each Business Unit for which the position is responsible, will complete activities to assure compliance with legal and corporate product safety and regulatory affairs requirements in a cost effective and efficient manner. The Senior Product Safety Specialist will support the Manager, Product Safety and Regulatory Affairs for each BU for which the position is responsible to implement practical technical and strategic product safety....

- Waltham, MA

TOP TIER PHARMACEUTICAL COMPANY in MASSACHUSETTSglobal biopharmaceutical company developing innovative medicines The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates Position SummaryWe have the need for a highly collaborative, experienced Manager of Medical Writing Operations to join our team based in MA. The position reports into our Director of Medical Writing and will lead writing responsibility of documents which ensure....


Three Medical Directors needed The Medical Director is a board-certified physician who has a history of clinical practice, and has significant experience in the cardio therapeutic area, Endocrinology or Renal, Nephrology therapeutic areas. The Medical Director is knowledgeable of the actions of regulatory bodies, in particular FDA, and has experience in clinical trials. An ideal candidate should have significant experience in renal cardio disease management and would thrive on proactively....

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