Author Jobs in Bunbury
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Editas Medicine-Bunbury WA
and purification processes using chromatography, crystallization, TFF, and related technologies.
• Apply DoE and QbD principles to define critical process parameters, material specifications, and process controls.
• Author and execute technology transfer packages...
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Editas Medicine-Bunbury WA
Nonclinical, Translational Medicine, Quality, Safety, Legal, and Program Management to ensure development plans and evidence packages are scientifically rigorous, operationally feasible, and regulatory-ready.
• Personally plan, author, coordinate, compile...
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appcast.io -
Editas Medicine-Bunbury WA
and purification processes using chromatography, crystallization, TFF, and related technologies.
• Apply DoE and QbD principles to define critical process parameters, material specifications, and process controls.
• Author and execute technology transfer packages...
Read more
Editas Medicine-Bunbury WA
Nonclinical, Translational Medicine, Quality, Safety, Legal, and Program Management to ensure development plans and evidence packages are scientifically rigorous, operationally feasible, and regulatory-ready.
• Personally plan, author, coordinate, compile...
Read more
appcast.io -
Beeline Medicines-Bunbury WA
and medical affairs objectives
• Manage global publication activities (author engagement, abstracts, manuscripts, posters, oral presentations) in compliance with GPP2022 and company SOPs
• Oversee the execution of plans for major international and regional...
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Cycle Pharmaceuticals-Bunbury WA
act as clinical lead in FDA meetings and author or review clinical content for regulatory submissions and briefing packages.
• Own the medical and scientific content of clinical protocols, amendments, statistical analysis plan inputs and informed...
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appcast.io -
Beeline Medicines-Bunbury WA
and medical affairs objectives
• Manage global publication activities (author engagement, abstracts, manuscripts, posters, oral presentations) in compliance with GPP2022 and company SOPs
• Oversee the execution of plans for major international and regional...
Read more
Isomorphic Labs-Bunbury WA
chemistry and biotransformation knowledge in collaboration with Chemistry Leads.
• Maintain knowledge of state‑of‑the‑art technologies and methods to increase confidence in human PK prediction.
• Author DMPK sections of regulatory documents.
• Embrace...
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Isomorphic Labs-Bunbury WA
and biotransformation knowledge in collaboration with Chemistry Leads.
• Maintain knowledge of state-of-the-art technologies and methods to increase confidence in human PK prediction.
• Author DMPK sections of regulatory documents.
• Embrace and champion a culture...
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Isomorphic Labs-Bunbury WA
assessment packages to support successful acceptance by regulatory agencies.
• Author toxicology sections of regulatory documents.
Predictive toxicology strategy
• Partner with Machine Learning colleagues to build the predictive toxicology aspects...
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Beeline Medicines-Bunbury WA
with KMEs, investigators, and HCPs — sharing clinical and emerging data, discussing unmet medical needs, and gathering external insights that inform overall development strategy.
• Review, author, and contribute to key clinical and regulatory documents...
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Isomorphic Labs-Bunbury WA
to inform dose optimization and the recommended phase 2 dose/schedule (RP2D) selection for pivotal studies.
• Regulatory Agency Interactions: Author and review human clinical pharmacology and biopharmaceutics sections for regulatory documents, including...
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Beeline Medicines-Bunbury WA
exchange with KMEs, investigators, and HCPs — sharing clinical and emerging data, discussing unmet medical needs, and gathering external insights that inform overall development strategy.
• Review, author, and contribute to key clinical and regulatory...
Read more
Isomorphic Labs-Bunbury WA
assessment packages to support successful acceptance by regulatory agencies.
• Author toxicology sections of regulatory documents.
Predictive toxicology strategy
• Partner with Machine Learning colleagues to build the predictive toxicology aspects...
Read more
Isomorphic Labs-Bunbury WA
to inform dose optimization and the recommended phase 2 dose/schedule (RP2D) selection for pivotal studies.
• Regulatory Agency Interactions: Author and review human clinical pharmacology and biopharmaceutics sections for regulatory documents, including INDs...
Read more
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