Author Jobs in Cambridge
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Eurofins USA PSS Insourcing Solutions-Cambridge
resource for potency assays.
Execution of complex GMP release and stability assays such as cell based functional assays, flow cytometry methods, ddPCR, ELISA, and NGS assays.
Author and review SOPs and technical reports.
Work with cross-functional groups...
resume-library.com -
Editas Medicine-Cambridge
research supporting development of HSC-based therapies from early discovery to regulatory filing.
• Establish SOPs, write prospective protocols, author study reports and regulatory documents, assist patent filing, and contribute to business development...
Katalyst Healthcares & Life Sciences-Cambridge
and review implementation plans to ensure up-to-date, compliant information is provided.
Labelling Document Management.
Author and manage the creation of new/revised labeling documents (TLP, CCDS, USPI, EU SmPC) with input from relevant functional areas...
resume-library.com -
Editas Medicine-Cambridge
and technology platforms.
• Author and review of regulatory submissions, technical reports, SOPs and work instructions.
• Maintain abreast latest industry trends and product knowledge, work cross-functionally (e.g. with Research, Business Development and Legal...
AbbVie-Cambridge
risks and provide recommendations for partnership or in-licensing.
Author and submit regulatory documents (IBs, INDs/CTAs, NDAs/BLAs, regulatory queries) and interact with regulatory agencies (US and ex-US) as needed.
Generate impurity, excipient...
resume-library.com -
Foghorn Therapeutics-Cambridge
to key decisions including candidate selection, development strategy, and clinical trial design
• Author and review preclinical study reports, including nonclinical toxicology, DMPK and biomarker sections of regulatory documents
• Design and interpret PK...
Cambridge
and reimbursement submissions
• Conducts post hoc analysis to support publications and presentations
• Reviews and authors abstract, manuscript, regulatory documents
• Collaborates with cross-functional team to support observational studies
• Develops statistical...
pharmiweb.jobs -
Editas Medicine-Cambridge
on-the-job training, career development, appraising performance, and promotions.
• Lead cross-functional projects/working teams, champion new ideas/business process improvements to advance company’s in vivo pipeline and technology platforms.
• Author...
workable.com -
Randstad-Cambridge
and labeling content at all levels.
• Ensures preparation and alignment of GLOC Chair(s) and GLOC members through respective functions.
Labeling Documents Authoring, Submission, and Labeling Negotiations
• Authors new/revised TLP, CCDS, USPI and/or EU SmPC...
randstadusa.com -
Foghorn Therapeutics-Cambridge
strategy, and clinical trial design
• Author and review preclinical study reports, including nonclinical toxicology, DMPK and biomarker sections of regulatory documents
• Design and interpret PK/PD, efficacy and toxicology studies in collaboration...
workable.com -
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