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Pharma-Industry and Consulting Experience:I have a wide range of experience in clinical, medical, pre-clinical and regulatory writing, project review and quality control of documents for audiences including medical, Pharma-industry and patients and carers.I have developed substantial understanding of European and global regulations and guidelines, with experience in the preparation and compilation of documents for European and global projects, for an extensive product portfolio within a wide range of therapeutic areas and pharmaceutical forms.Responsibilities included induction presentations and training/support for new members of staff.Academic Experience:Prior to entering clinical writing and regulatory affairs, I worked in academic research. Post-doctoral research interests were cannabinoid interactions with ion channels. I have authored or co-authored a number of peer-reviewed research papers, scientific reviews and meeting presentations.Activities included pre-clinical research into endogenous and exogenous cannabinoid interactions with T-type calcium channels. This work was presented as poster displays at national and international bio-medical conferences. I have authored/co-authored three peer-reviewed research papers.Specialties: Clinical PharmacologyRegulatory Medical WritingClinical Trials
Beone Medicines
View- Website:
- beonemedicines.com
- Employees:
- 1970
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Head Of Regulatory Affairs, AnzBeone MedicinesAustralia -
Head Of Regulatory Affairs, AnzBeigene May 2019 - PresentSydney, Australia -
Regulatory Affairs ManagerMerck May 2015 - Mar 2019
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Senior Regulatory Affairs AssociateMerck Jan 2014 - May 2015Sydney, AustraliaAssistance in the preparation of AU & NZ regulatory submissions.Maintenance of regulatory compliance programs and records. Compilation of material required for responses to Health Authority questions. Preparation of electronic submission documents. Participation in project development teams. Providing advice about regulatory requirements.Keeping abreast of regulatory procedures and changes. Preparation of departmental SOPs and procedures. Performing searches/analyses to address specific regulatory questions or issues.Mentoring of fellow associates.
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Regulatory Affairs AssociateMerck Dec 2011 - Dec 2013Sydney, AustraliaAssistance in the preparation of AU & NZ regulatory submissions.Maintenance of regulatory compliance programs and records. Compilation of material required for responses to Health Authority questions. Preparation of electronic submission documents. Participation in project development teams. Providing advice about regulatory requirements.Keeping abreast of regulatory procedures and changes. Preparation of departmental SOPs and procedures. Performing searches/analyses to address specific regulatory questions or issues.
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Senior Clinical WriterCatalent Pharma Solutions Mar 2011 - Jul 2011Swindon, United KingdomCore Responsibilities:To provide clinical writing and project management skills - to ensure that projects are completed in accordance with agreed timelines and in compliance with applicable regulations and client needs. To write and/or review a range of clinical study related documents including:- Investigator Brochures- Investigational Medicinal Product Dossiers (IMPD) - Briefing documents for Regulatory Authorities / Investors- Clinical Study Protocols- Clinical Study Reports- Clinical Overviews and Clinical Summaries for the CTD- Post submission writing activities- Journal Manuscripts- PIL user testing protocols, subject interviews and reportsTo support clinical study design for product development.To establish and foster a good business relationship with colleagues and clients, and to develop new business opportunities.To support the preparation of written estimates and proposals for clients, including timelines, milestones, activities and outcomes necessary in order to complete a project to a client's stated specifications.To represent Catalent Pharma Solutions Regulatory Affairs Consulting group at internal, client and Health Agency meetings. -
Clinical WriterCatalent Pharma Solutions Apr 2009 - Mar 2011Swindon, United KingdomCore Responsibilities:To provide clinical writing and project management skills - to ensure that projects are completed in accordance with agreed timelines and in compliance with applicable regulations and client needs. To write and/or review a range of clinical study related documents including:- Investigator Brochures- Investigational Medicinal Product Dossiers (IMPD) - Briefing documents for Regulatory Authorities / Investors- Clinical Study Protocols- Clinical Study Reports- Clinical Overviews and Clinical Summaries for the CTD- Post submission writing activities- Journal Manuscripts- PIL user testing protocols, subject interviews and reportsTo support clinical study design for product development.To establish and foster a good business relationship with colleagues and clients, and to develop new business opportunities.To support the preparation of written estimates and proposals for clients, including timelines, milestones, activities and outcomes necessary in order to complete a project to a client's stated specifications.To represent Catalent Pharma Solutions Regulatory Affairs Consulting group at internal, client and Health Agency meetings. -
Postdoctoral ResearcherUniversity Of Sydney Mar 2008 - Dec 2008Sydney, AustraliaContinuation of research carried out during PhD candidature - evaluation of endogenous and exogenous cannabinoid interactions with ion channels, particularly T-type calcium channels.
Hamish Ross Skills
Hamish Ross Education Details
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Neuroscience -
Pharmacology
Frequently Asked Questions about Hamish Ross
What company does Hamish Ross work for?
Hamish Ross works for Beone Medicines
What is Hamish Ross's role at the current company?
Hamish Ross's current role is Head of Regulatory Affairs, ANZ.
What is Hamish Ross's email address?
Hamish Ross's email address is ha****@****rck.com
What is Hamish Ross's direct phone number?
Hamish Ross's direct phone number is +614159*****
What schools did Hamish Ross attend?
Hamish Ross attended University Of Sydney, University Of Otago.
What skills is Hamish Ross known for?
Hamish Ross has skills like Clinical Pharmacology, Medical Writing, Clinical Trials, Regulatory Affairs, Clinical Development, Clinical, Therapeutic Areas, Protocol Development, Regulatory Submissions, Regulatory Requirements, Oncology, Life Sciences.
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Hamish Ross
Strategic Leadership, John Deere Precision Ag Technology @ Hutcheon & PearceWagga Wagga, Nsw1nab.com.au -
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☠︎ Hamish Ross
Content Publisher At Onepoint | Writing And Research (Zoology, Botany) At Waterford PressHeidelberg, Vic -
Hamish Ross
Australia
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