Author Jobs in Cambridge
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Aerial Talent-Cambridge-
focusing on bi- or multi-specific antibodies, to support successful IND submissions and progression to clinical trials.
• Study Design & Oversight: Design studies, author protocols, lead, and interpret in vivo IND-enabling studies, including non-GLP and GLP...
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Scorpion Therapeutics-Cambridge-mindmatch.ai-
with 21 CFR Part 11, EU Annex 11, GxP principles, and global data integrity expectations.
Author, revise, and own Quality System policies and procedures related to electronic systems and validation.
Represent Quality during internal audits, external...
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Draper-Cambridge-
or ASIC Hardware Engineering or related. Additional Job Description: You will develop verification approaches, author and execute verification plans, and use formal analysis tools. You will work in multi-disciplinary teams with opportunities to learn, grow...
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Cambridge-pharmiweb.jobs-
to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros
• Participate in the development of CRFs, edit check specifications, and data validation plans
• Provide review and/or author data transfer...
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Draper-Cambridge-
preferred. Experience
• Requires 5-7 years experience in systems analysis or related.
• Experience in integrating descriptive modeling tools with other simulation tools. Additional Job Description: You will develop verification approaches, author and execute...
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Pfizer-Cambridge-dejobs.org-
Successful record of scientific accomplishments evidenced by scientific publications and/or presentations with at least one first-author publication in a peer-reviewed journal **.**
+ Two letters of recommendation are also required prior to interview stage...
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Healthcare Businesswomen’s Association-Cambridge-appcast.io-
packages.
• Author nonclinical safety sections of internal and regulatory documents supporting clinical development and market approval (e.g., IND/NDA).
• Drive and coordinate communication strategies between PCS and R&D project teams.
• Participate...
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TetraScience-Cambridge-workable.com-
the gold standard for how the TetraScience OS is implemented.
• Standardize the Playbook: Transition our delivery from "bespoke" to "industrialized." You will author high-fidelity documentation, work instructions, and implementation frameworks in Confluence...
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Draper-Cambridge-
author and execute verification plans, and use formal analysis tools. While leading verification teams, you will define the test-bench architecture and verification approach. You will be responsible for developing methodologies and defining processes used...
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Pfizer-Cambridge-dejobs.org-
by pharmacological agents.
+ Facilitate and co-author manuscript submissions and publication to high impact peer-reviewed journals.
+ Maintain an awareness of 'cutting edge' scientific and technical developments in preclinical to clinical translation and apply...
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Scholar Rock-Cambridge-appcast.io-
Author, review, and approve QC‑related controlled documents, including specifications, protocols, reports, SOPs, method transfer plans, stability documents, and technical assessments as applicable.
• Build fit‑for‑purpose QC systems, governance...
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Pfizer-Cambridge-dejobs.org-
Successful record of scientific accomplishments evidenced by scientific publications and/or presentations with at least one first-author publication in a peer-reviewed journal
**Preferred Qualification or Nice to have:**
+ Understanding...
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Scorpion Therapeutics-Cambridge-appcast.io-
informed programmatic decision-making
• Support development and implementation of program biomarker plans and ensure successful implementation at study site(s)
• Lead/author clinical portions of regulatory submissions and responses to regulatory agency...
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Pfizer-Cambridge-dejobs.org-
in governance meetings and submissions, partners with/supports the Development lead/Medical Director regarding study and disease area strategy.
+ Author protocols, study level informed consent documents, and contributes to authoring of IBs, site training...
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Pfizer-Cambridge-dejobs.org-
and BDR.
+ Authors and manages approval of Informed Consent Documents (ICDs) including responses to external stakeholder questions.
+ Provides clinical input to development of the Integrated Quality Management Plan (IQMP). Review and approves final...
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