- Define and lead the global clinical data transparency strategy, ensuring alignment with corporate objectives, regulatory requirements, and patient advocacy initiatives.
- Act as Clients subject matter expert for , EU CTR (CTIS), EudraCT, EMA Policy 0070, Health Canada PRCI, and other global registry requirements.
- Anticipate and assess evolving disclosure and transparency regulations worldwide, driving proactive policy and process updates.
- Represent Apellis in external industry forums, working groups, and regulatory discussions related to data transparency.
- Establish and maintain Apellis' disclosure governance framework, including SOPs, quality standards, and audit readiness practices.
- Oversee development of redaction and anonymization strategies for clinical study documents and patient-level data, ensuring compliance with global privacy laws (e.g., GDPR, HIPPA).
- Provide strategic guidance on plain language summaries and patient-facing transparency deliverables.
- Direct and oversee the registration, results posting, and updates in , EU CTR, EudraCT, and other global registries.
- Ensure timely, accurate, and high-quality disclosure deliverables across all global development programs.
- Manage relationships with external vendors, technology platforms, and disclosure service providers.
- Partner with stakeholder functions (e.g., Clinical Development, Clinical Operations, Medical Writing, Biostatistics, Data Management, Pharmacovigilance, Legal, Corp Comms, Investor Relations, and Regulatory Affairs) to ensure consistency and accuracy of disclosed information.
- Provide training and strategic guidance to relevant teams on global transparency requirements and best practices.
- Foster a culture of accountability, quality, and innovation within the team and across RDMA.
- Work in company
Senior Manager, Clinical Trial Disclosure and Transparency
Only for registered members
The Senior Manager Clinical Trial Disclosure and Transparency is responsible for expertly carrying out operations for the accurate and timely disclosure of Alnylam trial information. · Ensure accurate timely consistent complete disclosure of clinical trial information in alignmen ...
Boston1 month ago
- Work in company
Senior Manager, Clinical Trial Disclosure and Transparency
Only for registered members
The Senior Manager is a key member of the Clinical Trial Disclosure and Transparency team working within Alnylam Medical Writing Expertise Area. Responsible for expertly carrying out operations for the accurate and timely disclosure of Alnylam trial information to regulatory agen ...
Boston Full time1 month ago
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The VP, Commercial & Corporate Counsel serves as counsel to the commercial organization and leads the corporate, contracts, and employment functions of the legal department. · ...
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We are seeking a hands-on Interim Senior Finance Manager to support and lead FP&A activities for a global publicly traded organization. · This high-visibility role provides both strategic financial leadership and direct execution across forecasting reporting and analytical delive ...
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+Make a global impact—join Repligen. · We're united by a mission to inspire advances in bioprocessing as a preferred partner in the production of biologic drugs that improve human health worldwide. · No matter your role or background... · Partner with the VP,... · ...
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· Company Overview: · Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. ...
Waltham, MA $180,000 - $320,000 (USD) per year4 days ago
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Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. · ...
Waltham, MA1 month ago
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We are seeking a hands-on Interim Senior Finance Manager to support and lead FP&A activities for a global publicly traded organization. · This high-visibility role provides both strategic financial leadership and direct execution across forecasting reporting analytical deliverabl ...
Waltham, MA1 month ago
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+Job summary · The Unaccompanied Refugee Minors (URM) · Youth and Family Specialist provides culturally sensitive intensive case management, outreach and direct service to Unaccompanied Refugee Minor Program's youth in coordination and cooperation with systems including: school p ...
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We do dentistry differently at Tend without compromising on excellence or ambition. As a Lead Dentist you'll set the bar for clinical quality mentor a high-performing team and help shape the patient experience across your studio. · ...
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Associate Dentist at Tend delivers best-in-class clinical care in a modern studio with an experienced team. · ...
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We are seeking a highly skilled and detail-oriented Corporate & Securities Counsel to join our growing legal team.This individual will play a critical role in supporting the company's public company reporting obligations and broader corporate governance needs. · ...
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We are seeking a highly skilled and detail-oriented Corporate & Securities Counsel to join our growing legal team. The ideal candidate will bring strong securities law experience from a top law firm and/or in-house legal department. Prepare and review periodic reports. · Support ...
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The Senior Tax Associate will be responsible for managing state, local and indirect tax exposure, filings, exemptions and answering questions about tax and tax relationships. · ...
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We are on a journey towards our bold ambition of being the global-leader of convenient good for you fruit-based food and beverages. To turn this goal into a reality we need you and other exceptionally talented agile and innovative individuals who are eager to contribute to someth ...
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- Work in company
Temporary Online Course Developer – RUCD ### – AI for Human-Centered Design
Only for registered members
Brandeis University's Rabb School of Continuing Studies is seeking a skilled online course developer to design and build a new three credit asynchronous online course titled: AI for Human-Centered Design. · ...
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· ***$5000 Full Time Sign On Bonus Available*** · Hiring in Post Office Square, Fenway, Kendall Square, and South Boston · We offer a competitive hourly rate plus a monthly performance bonus tied to your production and clinical excellence. Our top-earning Hygienists make up to $ ...
Waltham $52,480 - $74,560 (USD) per year19 hours ago
Associate Director, Clinical Data Transparency and Disclosure - Waltham - Talent groups
Description
Key Responsibilities-
Senior Manager, Clinical Trial Disclosure and Transparency
Only for registered members Boston
-
Senior Manager, Clinical Trial Disclosure and Transparency
Full time Only for registered members Boston
-
Vice President, Commercial
Full time Only for registered members Waltham
-
Vice President, Commercial
Only for registered members Waltham, MA
-
Financial Reporting Intern
Only for registered members Waltham, MA
-
Senior Finance Manager
Only for registered members Waltham
-
Investor Relations Manager
Only for registered members Waltham
-
Vice President, Commercial
Only for registered members Waltham, MA
-
Vice President, Commercial
Only for registered members Waltham, MA
-
Senior Finance Manager
Only for registered members Waltham, MA
-
Unaccompanied Refugee Minor
Only for registered members Waltham
-
Lead Dentist
Tend- Waltham
-
Associate Dentist
Tend- Waltham
-
Associate Director/Director, Corporate
Only for registered members Waltham
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Associate Director/Director, Corporate
Full time Only for registered members Waltham
-
Senior Tax Associate
Only for registered members Waltham
-
Manager, Sustainability and Regulatory Compliance
Only for registered members Waltham
-
Temporary Online Course Developer – RUCD ### – AI for Human-Centered Design
Part time Only for registered members Waltham
-
Director, Benefits
Full time Only for registered members Waltham
-
Dental Hygienist
Tend- Waltham