Regulatory Publishing Senior Manager (Contract)
Vertex Pharmaceuticals, Boston, Massachusetts, us, 02298
Job Description
The Regulatory Publishing Senior Manager is responsible for the creation, assembly, and publishing of electronic submissions and the delivery to global health authorities in an efficient and timely manner. The role is accountable for leading publishing activities on a portfolio level and responsible for the maintenance and lifecycle management submissions that are inter-related and dependent on multiple concurrent submissions. Can lead complex submission work across programs. This role will work with stakeholders and project teams for the timely delivery of content to be published, as well as drive for project teams the standards and expectations of format. This role is responsible for the accuracy of published output to Vertex and industry standards and health authority requirements. The Regulatory Publishing Senior Manager will be responsible for leading process improvements for the accurate and quality driven execution of submissions. Key Duties and Responsibilities: Works independently within the publishing/content systems to create published output for submission Creates and assembles all components of defined submissions in required format as per health authority guidance Validates submissions through the application of acquired experience Manage portfolio views of upcoming submissions and publishing interdependencies Collaborates with submission managers and regulatory leads for submission preparation and timelines Liaises with functional source areas to ensure documents are compliant and submission ready Collaborates with regulatory document authors to achieve resolution and ensure that documents comply with regulatory and company guidance/template specifications Requires a good understanding and the ability to advise of the regulations and processes that govern the content and maintenance of controlled documents required by the Health Authorities and ICH Responsible for periodical testing of system improvements/HA updates within publishing environment Knowledge and Skills: Experience in industry standard publishing software and validation systems Knowledge of types of Global HA submissions and their requirements and guidelines Ability to work with firm deadlines and adapt quickly to changing requirements and priorities Ability to prioritize portfolio of publishing activities on programs Ability to educate and train other team members and influence cross functional stakeholders in submission ready concepts Strong organization, written/verbal communication, and attention to detail Knowledge of health authority procedures/guidance's regarding electronic submissions Highly skilled in use of Electronic Document Management Systems Ability to balance multiple tasks to meet priorities and timelines Education and Experience: Bachelor’s Degree in life sciences or technology area Typically requires 7 Years of eCTD publishing experience or the equivalent combination of education and experience Contract Length:
Through the end of the year, with the chance to extend Pay Range
$85/hr.-$92/hr. Shift/Hours
Monday - Friday Requisition Disclaimer
This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements By applying for this position, you agree to the Atrium Terms and Conditions and you direct Atrium to share your application materials, which may include your CV/Resume, email address or phone number, with Vertex. For more information on how Vertex handles your personal data related to your job application, please see Vertex’s Careers Privacy Notice.
Agreeing to the Atrium Terms and Conditions, includes permission to use the email address and mobile phone number you provide during the application process or throughout the duration of your prospective or actual employment to notify you of job openings, profiles, articles, news, and other employment-related information, as well as to notify you of special promotions or additional products and services offered by us or our affiliates and partners (collectively, “Atrium Alerts”). Atrium Alerts may be sent by email, phone, or text message. Your personal information will be safely stored within the Atrium & Vertex databases. Atrium does not sell your personal information to third parties. Text message and data rates may apply. To OPT OUT of text messaging or to modify your communication preferences for Atrium Alerts at any time, please contact Atrium at privacyadministrator@atriumstaff.com. If you do not agree with the Atrium Terms and Conditions, you can still complete your application for this position by emailing your resume to our team at tempstaffing@vrtx.com. Please include the job title in the subject of your email. No C2C or Third-Party Vendors
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The Regulatory Publishing Senior Manager is responsible for the creation, assembly, and publishing of electronic submissions and the delivery to global health authorities in an efficient and timely manner. The role is accountable for leading publishing activities on a portfolio level and responsible for the maintenance and lifecycle management submissions that are inter-related and dependent on multiple concurrent submissions. Can lead complex submission work across programs. This role will work with stakeholders and project teams for the timely delivery of content to be published, as well as drive for project teams the standards and expectations of format. This role is responsible for the accuracy of published output to Vertex and industry standards and health authority requirements. The Regulatory Publishing Senior Manager will be responsible for leading process improvements for the accurate and quality driven execution of submissions. Key Duties and Responsibilities: Works independently within the publishing/content systems to create published output for submission Creates and assembles all components of defined submissions in required format as per health authority guidance Validates submissions through the application of acquired experience Manage portfolio views of upcoming submissions and publishing interdependencies Collaborates with submission managers and regulatory leads for submission preparation and timelines Liaises with functional source areas to ensure documents are compliant and submission ready Collaborates with regulatory document authors to achieve resolution and ensure that documents comply with regulatory and company guidance/template specifications Requires a good understanding and the ability to advise of the regulations and processes that govern the content and maintenance of controlled documents required by the Health Authorities and ICH Responsible for periodical testing of system improvements/HA updates within publishing environment Knowledge and Skills: Experience in industry standard publishing software and validation systems Knowledge of types of Global HA submissions and their requirements and guidelines Ability to work with firm deadlines and adapt quickly to changing requirements and priorities Ability to prioritize portfolio of publishing activities on programs Ability to educate and train other team members and influence cross functional stakeholders in submission ready concepts Strong organization, written/verbal communication, and attention to detail Knowledge of health authority procedures/guidance's regarding electronic submissions Highly skilled in use of Electronic Document Management Systems Ability to balance multiple tasks to meet priorities and timelines Education and Experience: Bachelor’s Degree in life sciences or technology area Typically requires 7 Years of eCTD publishing experience or the equivalent combination of education and experience Contract Length:
Through the end of the year, with the chance to extend Pay Range
$85/hr.-$92/hr. Shift/Hours
Monday - Friday Requisition Disclaimer
This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements By applying for this position, you agree to the Atrium Terms and Conditions and you direct Atrium to share your application materials, which may include your CV/Resume, email address or phone number, with Vertex. For more information on how Vertex handles your personal data related to your job application, please see Vertex’s Careers Privacy Notice.
Agreeing to the Atrium Terms and Conditions, includes permission to use the email address and mobile phone number you provide during the application process or throughout the duration of your prospective or actual employment to notify you of job openings, profiles, articles, news, and other employment-related information, as well as to notify you of special promotions or additional products and services offered by us or our affiliates and partners (collectively, “Atrium Alerts”). Atrium Alerts may be sent by email, phone, or text message. Your personal information will be safely stored within the Atrium & Vertex databases. Atrium does not sell your personal information to third parties. Text message and data rates may apply. To OPT OUT of text messaging or to modify your communication preferences for Atrium Alerts at any time, please contact Atrium at privacyadministrator@atriumstaff.com. If you do not agree with the Atrium Terms and Conditions, you can still complete your application for this position by emailing your resume to our team at tempstaffing@vrtx.com. Please include the job title in the subject of your email. No C2C or Third-Party Vendors
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