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Biotech Jobs in Malvern, Pennsylvania

462 jobs

Our client is currently seeking a Technical Quality Officer/Validation Engineer. Essential Functions: Actively manage and be involved in the execution of all stages of the validation life-cycle including: •Development of project design documentation. •Generating validation plans for larger projects. •Performing risk assessment of validation requirements. •Liaison with non-Pharma Services personne...
Machine Learner Researcher The QuintilesIMS Analytics Center Of Excellence (ACOE) is building a clinical trial analytics team that aims to be a global leader in the application of large data within the drug development industry. Joining the ACOE team provides the opportunity to work with extremely complex data and methodologies in a fast-paced, ever-changing environment. We seek highly motivated p...
Supports moderately complex clinical trial activities in support of the Clinical Trial Manager. The CTS works closely with the clinical trial team to ensure site related start-up through close-out activities are conducted according to Good Clinical Practice (GCP) and relevant SOP's. The CTS may assist with vendor oversight and management. They will identify issues in a timely manner and escalates...
The Clinical Scientist role is an exciting opportunity for a highly motivated individual to contribute to the development and execution of the clinical strategy and plans for Oncology programs. Contribute to the design of clinical studies in close collaboration with the Medical Lead as well as the entire Clinical Development team. Write and coordinate finalization of clinical study documents (e.g...
Engineering/Marketing$65,000 To $80,000 Product Development Specialist (Marketing Medical Devices) My client, a leader in medical device products for the operating room, is seeking a BSME with 0ne to three years’ experience, working a combination of product design and business development. This is a great position for the product design engineer to get involved with marketing and traveling to maj...
Clinical Study Manager Candidate can be remote, or work out of Collegeville or the NYC office 6 Months+ Description: · Work with alliance partners, coordination with third parties, to ensure inspection readiness, identify potential high risks for regulatory inspections. · Participate on a cross functional team focused on US regulatory submissions · Pharmaceutical/biotech experience mandatory. · S...
Amec Foster Wheeler (www.amecfw.com) designs, delivers and maintains strategic and complex assets for its customers across the global energy and related sectors. Employing around 36,000 people in more than 55 countries and with 2015 revenues of £5.5 billion, the company operates across the oil and gas industry – from production through to refining, processing and distribution of derivative produc...
Job Title: Senior Scientist (Bioanalytical) Job Duties: - Perform analysis of biological samples to support drug discovery & development for potential drug candidates such as bioanalytical method development, method validation & sample analysis using LC-MS/MS and ELISA. - Detail oriented and organized. - Excellent writing, communication and presentation skills are required. - The candidate must b...
Job Title: Vendor Management Lead IV Responsibilities • Responsible for a portfolio of IT contracts across both goods and services for a mix of providers. This role will partner with other members of the VMO, procurement, legal, HR, finance, and IT stakeholders to holistically manage the contracts for those providers. • Categorize vendors as strategic, niche, major or commodity. Shire works with...
Responsibilities: - Perform compendial testing in a cGMP environment - Sample preparation and analysis through wet chemistry, including: pH testing, heavy metals, titrations - Apply cGMP regulations at all times, including in the preparation of qualification documentation - Perform lab investigations, OOS (Out-Of-Specification) and OOT (Out-Of-Tolerance) as required _cc_ xsysjscx _cn_ Joule Scie...
The Johnson and Johnson Medical Device (MD) Sector ClinicalResearch and Development Center of Excellence (CR&D COE) is recruiting fora Staff Clinical Research Scientist located in Warsaw, IN; Leeds, England;Westchester, PA; OR Raynham, MA. The location preference would be for Warsaw orLeeds. The MD CR&D COE is being created to support all clinicalactivities across all business units within the Jo...
Job Title: Sr. Quality Assurance Associate Responsibilities • Takes ownership of managing the QMS, including activities related to management of document control, training program, deviations, CAPA and other QMS processes • Oversees quality incident process including tracking, meetings, writing client incident reports as required • Supports internal and client audit hosting, including follow up o...
Must Haves: · Medical Degree Required · 3+ years Drug Safety experience with post marketed products · Prior experience performing medical review of reports and literature · Excellent Communication Skills Responsibilities: · Responsible for the accurate and timely reporting of product safety information to the organization and regulatory authorities world-wide · Perform in depth medical review of...
Title: Clinical Data Manager The Clinical Data Manager is responsible for performing activities pertaining to the conduct of Phase I – III clinical trials in accordance with ICH/Good Clinical Practices (GCP) and other relevant procedures and guidelines to ensure that a quality work product is produced and timelines and deliverables are met. Job Responsibilities Participate as the primary data man...
Job Title: Medical Information Specialist Position Description • Research and respond to Medical Requests for Information (MIRs) from healthcare professionals. • Liaise with cross-functional Medical, Clinical, Regulatory, and innovation teams to maintain knowledge of current literature in order to provide highest quality, accurate, and fair balanced response to HCPs within the guidelines and regu...
Research and respond to Medical Information Requests (MIRs) from healthcare professionals. Liaise with cross-functional Medical, Clinical, Regulatory, and innovation teams to maintain knowledge of current literature in order to provide highest quality, accurate, and fair balanced response to HCPs within the guidelines and regulations Plan and develop standard response letters (SRLs) working colla...
Job Description: The selected candidate will actively research and develop new ideas/concepts from a variety of industry resources and scientific literature for the creation of innovative formulations for personal care products (such as color cosmetics, skin, sun and body care). He/she will be mainly responsible for concept creations to prototype development. Responsibilities: • Independently for...
Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for a Postdoctoral Fellow, Computational Biology with an emphasis in Immune-Oncology in Spring House, PA. The length of this postdoctoral fellow opportunity will be 24 months. Janssen discovers and develops some of the most innovative technology platforms and medicines today. We are a wo...
The focus of the position will be on global life cycle management activities for existing and future indications for an investigational new product in the Jazz Sleep franchise. This position will work collaboratively with biostatisticians, statistical programmers, clinical scientists, regulatory and commercial colleagues, as well as external key opinion leaders and regulatory agencies on designin...
Within the Optum Shared Services business this Associate Director, Medical and Clinical Operations position will be responsible for all direct operational activity. You will lead the building and support of robust relationships with key Health Plan clinical leaders. You will also lead innovation by proactively making recommendations on program design to ensure program performance to meet or excee...