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Description:
FULLY REMOTE - Pacific Standard PST Time Zone
Regulatory Writing Sr Manager
ln this vital role role you will serve as the functional area lead on product
teams lead writing activities for complex product submissions provide functional area expertise train and
mentor more junior writers and lead departmental activities.
Key responsibilities include:
• Author or oversee the authoring of all regulatory submission documents including Clinical
Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol
Amendments, Informed Consent Forms, Table of All Studies, Clinical Overview Addenda,
eCTD Module 2 Clinical Summary Documents, Briefing Documents, and Pediatric
Investigation Plans
• Conduct the formal review and approval of authored documents, following applicable
standard operating procedures
• With limited supervision, lead regulatory writing activities for complex product submissions,
including new and supplemental drug applications/biologics license applications
• Serve as functional area lead on product teams (e.g., Global Regulatory Team, Evidence
Generation Team, Global Safety Team, Label Working Group)
• Provide functional area input for Global Regulatory Plan and team goals
Supervise the work of contract and freelance writers and mentor junior medical writers as
assigned
• Lead departmental and cross-departmental initiatives, as appropriate
• Generate document timelines
Preferred Qualifications:
bull Experience leading writing activities for new or supplemental drug applications/biologics
license applications is strongly preferred
bull Experience with regulatory documents in Regulatory Affairs Research Development or
related area
bull 5years of experience in medical writing in the Biotech/Pharmaceutical industry
Additional Skills & Qualifications:
Basic Qualifications:
Doctorate degree 2 years of directly related experience
OR
Master’s degree and 6 years of directly related experience
OR
Bachelor’s degree and 8 years of directly related experience
OR
Associate’s degree and 10 years of directly related experience
Or
High school diploma / GED and 12 years of directly related experience
About Aston Carter:
Aston Carter provides world-class corporate talent solutions to thousands of clients across the globe. Specialized in accounting, finance, human resources, talent acquisition, procurement, supply chain and select administrative professions, we extend the capabilities of industry-leading companies. We draw on our deep recruiting expertise and expansive network to meet the evolving needs of our clients and talent community with agility and excellence. With offices across the U.S., Canada, Asia Pacific and Europe, Aston Carter serves many of the Fortune 500. We are proud to be a ClearlyRated Best of Staffing® double diamond winner for both client and talent service.
Diversity, Equity & Inclusion
At Aston Carter, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email astoncarteraccommodation@astoncarter.com (%20astoncarteraccommodation@astoncarter.com) for other accommodation options.