Publishing • boston ma
Lead and manage publishing activities for IND, NDA, ANDA, Amendments, Supplements, Responses, Annual Reports, Safety Reports, and Promotional Submissions.Oversee submission-level and document-level... Show more
Senior Manager Of Product Development.MIT Press, to help shape next-generation publishing models, knowledge products, and strategic partnerships.This individual-contributor role identifies, incubat... Show more
Regulatory Submission Delivery Manager.IRI believes in commitment, integrity and strategic workforce solutions.We deliver strategic workforce solutions that help you manage your talent and business... Show more
This is a hands-on, end-to-end role covering strategy, account setup, content planning, production management, publishing, audience growth, community management, and performance optimization across... Show more
Seeking a Program Manager to come aboard the team of our pharma marketing client as a full-time employee.This person will lead cross-functional web technology initiatives by overseeing the planning... Show more
Location: Hybrid / 2 days in Boston office.No Viop or Google Voice number required.What are the top three must-haves you will be looking for in the resumes/interviews for this role?.Content publish... Show more
Scientific Writer (Onsite Consultant).The ideal candidate will have a.PhD or Master's degree in a science discipline.Help frame, edit, and refine scientific manuscripts, white papers, technical bri... Show more
Regulatory Publishing Senior Manager.The Regulatory Publishing Senior Manager is responsible for the creation, assembly, and publishing of electronic submissions and the delivery to global health a... Show more
Associate Director, Regulatory Operations.At Merida Biosciences, we are pioneering true precision medicines for antibody-driven diseases.We specifically target pathogenic antibodies and their cellu... Show more
As an Acquisitions Editor for the Medical School portfolios, situated within the Medical Education and Medical Practice business unit, you have an opportunity to join an award-winning team that is ... Show more
Boston, Massachusetts, United States.Publishing Associate needs 2+ years of educational publishing experience, or relevant equivalent experience.Publishing Associate requires:.Excellent written and... Show more
The Training/Change Management Coordinator reports to the Associate Director of Shared Services and delivers training and change management capabilities to support the daily operation and overall s... Show more
Head Of Content Operations (VP).State Street Investment Management is seeking a Head of Content Operations to help ensure our content is delivered efficiently, accurately, and in line with regulato... Show more
Hachette Book Group is seeking a talented Royalty Analyst to support our Finance team! The Royalty Analyst is responsible for reviewing all new contracts acquired by Hachette Book Group that fall i... Show more
Vice President, Head of Global Regulatory Operations.Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Diseas... Show more
FutureSight is seeking a Co-Founder & CEO to lead.AI-native content intelligence and publishing venture.This is a co-founder partnership with meaningful founder equity, not a salaried executive... Show more
The ideal candidate will possess expertise across several sectors of the music industry, such as artist management, record label operations, music publishing, music marketing, distribution, rights ... Show more
Title: Acquisitions Editor for Adult Titles Full Time.Hybrid or offsite may be considered.The primary responsibility for the Acquisitions Editor (AE) for Adult Titles at Pauline Books & Media (... Show more
Harvard Business Review (HBR) is seeking a Marketing Coordinator to support and execute integrated marketing initiatives across print, digital, podcasts, and events.This role plays a critical part ... Show more
The average salary range is between $ 52,500 and $ 125,000 year , with the average salary hovering around $ 100,000 year .
The average salary range is between $ 45,215 and $ 146,250 year , with the average salary hovering around $ 72,927 year .
Lead and manage publishing activities for IND, NDA, ANDA, Amendments, Supplements, Responses, Annual Reports, Safety Reports, and Promotional Submissions.
Oversee submission-level and document-level publishing including metadata, hyperlinking, bookmarking, TOCs, and lifecycle management.
Perform and oversee quality control checks to ensure error-free regulatory submissions.
Manage workload allocation, tracking, and timely delivery across teams.
Support and mentor team members; conduct training sessions on publishing standards and processes.
Handle client communication, status updates, and submission readiness reviews.
Manage post-publishing activities including archiving and authority acknowledgements.
Contribute to process improvements, automation, and business growth initiatives.
Bachelor's or Master's degree in Pharmacy, Life Sciences, or a related discipline.
Strong expertise in eCTD/NeeS publishing for US market.
Strong expertise knowledge of the Archival process.
Hands-on experience with publishing tools such as DocuBridge, EXTEDO eCTD Manager, ISI Toolbox, Adobe Acrobat, and validation tools (Lorenz/eValidator).
In-depth knowledge of ICH and regional regulatory submission guidelines.
Experience in handling validation errors and troubleshooting technical issues.
Strong stakeholder management, communication, and leadership skills.
Ability to work in fast-paced, changing regulatory environments.
Minimum 5 - 10 years' experience for handling submission and Archival.
