Senior Medical Writer - REMOTE
Proclinical is seeking a remote Senior Medical Writer for a global biopharmaceutical company.
Must be eligible to work in the US.
Job
Responsibilities:
Main Medical Writing responsibilities Manage the preparation of a complex suite of regulatory documents e.
g.
protocols, CSRs, briefing documents, meeting requests, investigator brochures, clinical modules Lead Writing/Editing complex Clinical Dossiers/Safety Reports Review documents to ensure compliance with documentation quality standards, regulatory requirements and consistency of messages across all documents for a product within a clinical dossier Plan and create timelines to produce assigned documents Ensure proper planning and resourcing of all documents assigned to Writing/Editing Team Actively contribute to best practices and continuous improvement within the therapeutic Area Represent the group in functional and cross functional initiatives/projects when required Network and share best practices to ensure efficiency and consistency across product teams Project Delivery Able to work across multiple projects and accounts simultaneously Demonstrate a thorough understanding of timelines, budgetary constraints and scopes of work Adhere to the quality control process and ensure all work produced has gone through the correct internal review process Demonstrate a good understanding of project management and resource planning Maintain a working knowledge of pharmaceutical industry standards and compliance Stay informed of upcoming projects, assist management in projecting resources, and perform administrative duties as requested Identify and participate in the qualification of Medical Writing consultants and vendors, and oversee their writing activities to ensure timely and quality deliverables are completed within budget Communication Understand the purpose and role of communications in the wider therapy area and commercial landscape Demonstrate the ability to communicate clearly to different audiences through a variety of media (print and digital) Identify and communicate important therapy area updates and any medical/regulatory milestones to the team and clients where appropriate.
Link this with any potential new business opportunities where applicable Provide regular feedback to senior teams across accounts and projects Mentor less experienced medical writers EHS
Responsibilities:
Comply with applicable EHS regulations and procedures.
Participate in the site's EHS performance by reporting risks, malfunctions or improvements Participate in mandatory EHS training Skills and Requirements:
Life sciences degree, preferably MSc or PhD, or equivalent combination of education and experience Minimum 5 years Medical Writing experience in either a CRO or pharmaceutical company Working knowledge of ICH and US regulatory requirements is required; working knowledge of other ex-US regulatory requirements is desired Working knowledge of drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, and medical terminology Recognized industry qualification in Medical Writing (such as the professional development qualifications provided by the American and European Medical Writing Associations) would be advantageous Proficient in using Microsoft Office programs (e.
g.
PowerPoint, Excel, etc.
) Have an excellent command of the English language in both written and verbal communications desirable Previous experience in a medical communications agency or industry would be advantageous A keen interest in working and developing scientific expertise across a range of therapy areas Flexible approach to working, with the ability to reprioritize and work under pressure when needed Excellent time management skills and demonstrated ability to forecast and manage workload English (Excellent level both written and verbal) Experience as a clinical/regulatory/safety Medical Writer, i.
e.
, preparation of a wide range of clinical/regulatory documents including Clinical Study Reports, Protocols, Subject Narratives, Investigator Brochures, Regulatory Submission Modules, Safety Reports, and Manuscripts.
Able to manage coordination responsibilities beyond writing individual documents, e.
g.
, timelines, reviews and submissions If you are having difficulty in applying or if you have any questions, please contact Patrick Mooney at +(1) 619-963-2702 or email protected .
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
#LI-PM2 Recommended Skills Administration Biostatistics Business Process Improvement Clinical Research Clinical Study Design Clinical Study Reports Estimated Salary: $20 to $28 per hour based on qualifications.
Must be eligible to work in the US.
Job
Responsibilities:
Main Medical Writing responsibilities Manage the preparation of a complex suite of regulatory documents e.
g.
protocols, CSRs, briefing documents, meeting requests, investigator brochures, clinical modules Lead Writing/Editing complex Clinical Dossiers/Safety Reports Review documents to ensure compliance with documentation quality standards, regulatory requirements and consistency of messages across all documents for a product within a clinical dossier Plan and create timelines to produce assigned documents Ensure proper planning and resourcing of all documents assigned to Writing/Editing Team Actively contribute to best practices and continuous improvement within the therapeutic Area Represent the group in functional and cross functional initiatives/projects when required Network and share best practices to ensure efficiency and consistency across product teams Project Delivery Able to work across multiple projects and accounts simultaneously Demonstrate a thorough understanding of timelines, budgetary constraints and scopes of work Adhere to the quality control process and ensure all work produced has gone through the correct internal review process Demonstrate a good understanding of project management and resource planning Maintain a working knowledge of pharmaceutical industry standards and compliance Stay informed of upcoming projects, assist management in projecting resources, and perform administrative duties as requested Identify and participate in the qualification of Medical Writing consultants and vendors, and oversee their writing activities to ensure timely and quality deliverables are completed within budget Communication Understand the purpose and role of communications in the wider therapy area and commercial landscape Demonstrate the ability to communicate clearly to different audiences through a variety of media (print and digital) Identify and communicate important therapy area updates and any medical/regulatory milestones to the team and clients where appropriate.
Link this with any potential new business opportunities where applicable Provide regular feedback to senior teams across accounts and projects Mentor less experienced medical writers EHS
Responsibilities:
Comply with applicable EHS regulations and procedures.
Participate in the site's EHS performance by reporting risks, malfunctions or improvements Participate in mandatory EHS training Skills and Requirements:
Life sciences degree, preferably MSc or PhD, or equivalent combination of education and experience Minimum 5 years Medical Writing experience in either a CRO or pharmaceutical company Working knowledge of ICH and US regulatory requirements is required; working knowledge of other ex-US regulatory requirements is desired Working knowledge of drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, and medical terminology Recognized industry qualification in Medical Writing (such as the professional development qualifications provided by the American and European Medical Writing Associations) would be advantageous Proficient in using Microsoft Office programs (e.
g.
PowerPoint, Excel, etc.
) Have an excellent command of the English language in both written and verbal communications desirable Previous experience in a medical communications agency or industry would be advantageous A keen interest in working and developing scientific expertise across a range of therapy areas Flexible approach to working, with the ability to reprioritize and work under pressure when needed Excellent time management skills and demonstrated ability to forecast and manage workload English (Excellent level both written and verbal) Experience as a clinical/regulatory/safety Medical Writer, i.
e.
, preparation of a wide range of clinical/regulatory documents including Clinical Study Reports, Protocols, Subject Narratives, Investigator Brochures, Regulatory Submission Modules, Safety Reports, and Manuscripts.
Able to manage coordination responsibilities beyond writing individual documents, e.
g.
, timelines, reviews and submissions If you are having difficulty in applying or if you have any questions, please contact Patrick Mooney at +(1) 619-963-2702 or email protected .
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
#LI-PM2 Recommended Skills Administration Biostatistics Business Process Improvement Clinical Research Clinical Study Design Clinical Study Reports Estimated Salary: $20 to $28 per hour based on qualifications.
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