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We are looking for a talented individual to join our dynamic Drug Product Development team within the Company’s Biologics CMC organization, where we drive the maintenance and evolution of both clinical and commercial products and programs.
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A Biochemistry Senior Investigator is responsible for: conduction, and writing of complex GMP laboratory investigations; collaborating with technical and support staff to write, author and assist in implementation of effective Corrective Action/Preventive Actions (CAPA); support management by assisting and addressing internal and external audits; utilize all laboratory systems to accomplish these tasks.
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This individual will be responsible for following Quality Control procedures on the installation, qualification, and maintenance of GMP analytical instruments in Clinical Release & Stability labs.
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Clinical time is devoted to the outpatient Cancer Risk and Prevention Clinic at Maine Medical Center Cancer Institute in Scarborough. Specific responsibilities of the cancer genetics counselor include the following: Family history analyses and pedigree maintenance; data coordination; chart organization; writing/dictation of consultation and summary letters to patients; Patient question follow-up; Informed consent process; Follow up with lab orders; Insurance pre-approvals; Insurance appeals; Physician contact and follow up.
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Must have at least 3-5 years of industry regulatory writing and clinical medical writing experience. Substantial clinical study protocol experience, as lead author, required.
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Kelly FSP Science and Clinical is currently seeking a Technical Writer 1 for a long-term engagement with one of our Global Pharmaceutical clients. Technical writing knowledge in the medical device industry, preferably.
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The Psychologist II also carries a reduced clinical caseload on the unit, contributing their experience in intervention and psychological assessment when appropriate. The Psychologist II will be the primary supervisor for trainees, overseeing their documentation, report writing, individual and group therapy skills (primarily DBT and other Evidenced Based Treatments), as well as trainings specific to an inpatient population.
$50.38 - $78.03 an hourFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Reports and Submissions: May contribute to writing minor safety sections of the NDA, CSR, and IB. May review any safety submissions for medical accuracy. Position supports safety monitoring and risk management activities, provides insights on current clinical practice and guidelines, reviews and provides written assessments of relevant medical topics, and supports PV Operations' medical review function.
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Knowledge of statistical theory, in particular survival analysis, epidemiology, and clinical trials. StataCorps biostatisticians are continually expanding the statistical features of Stata, so they perform a myriad of tasks, ranging from working with users and each other to identify features to be added, validating statistical methods, programming in C and Stata, and writing documentation.
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The Senior Director of Medical Writing will have responsibility for executing a fit-for-purpose delivery model to produce a range of high quality clinical and regulatory documents to advance company goals across all investigational and marketed products.
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Requires a Bachelor’s degree in science or English/Communications (PhD, PharmD, or Master’s degree highly preferred) with significant relevant scientific experience, a minimum of 6+ years relevant pharmaceutical and/or medical device industry experience, and at least 3+ years of specific medical writing experience in the pharmaceutical industry (including development of clinical study outlines, protocols, study reports, investigator brochures, and IND/BLA/NDA sections.
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Clinical project implementation and management is required, Epic or Meditech specific experience is preferred. Planning, writing, and overseeing user support documentation efforts, including online help screens.
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Turkish, Hindi, Punjabi, Bengali, French, Arabic/English – ability to communicate well both verbally and in writing. Master’s degree in social work (MSW) counseling, psychology or other relevant behavioral science field in which clinical training and experience is a program requirement and one year of postgraduate direct mental health service delivery.
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Support production needs and continuous improvement including change control, deviation writing / review, CAPA implementation, and operational optimization. Improving lives globally with 20+ years experience in clinical research and strategic resourcing.
$60 - $78 an hourExpandApply NowActive JobUpdated 14 days ago - UpvoteDownvoteShare Job
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2+ years experience maintaining and writing/optimizing methods on automated liquid handling systems (e.g. MultiFlo/Bravo, STAR/STARlet, Echo, Lynx, Lunatic, high throughput NGS sequencers) The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test.
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writing clinical jobs
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