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REGULATORY WRITING SENIOR MANAGER

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,...

CompanyBiospace
AddressWashington, DC
CategorySales/marketing
Job typeFull time
Date Posted 4 weeks ago See detail

Regulatory Writing Senior Manager

Biospace

Washington, DC

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,...

Senior Manager, Advocacy & Legislative Analysis

Biospace

Washington, DC

Manage project deliverables in the DC Office using proven project management tools to assure on time deliverables. Prepare monthly legislative reports for internal executive distribution and regular key updates that would benefit...

Biostatistical Programming Senior Manager- US Remote

Biospace

Washington, DC

Accountable and responsible for Global Statistical Programming (GSP) study deliverables and submission activities for a group of Amgen products. Set and drive forward the programming strategies such as functional standards and in...

Senior Web Manager

Rape, Abuse & Incest National Network

Washington, DC

Website Management: Oversee the day-to-day operation and maintenance of the organization's website with fidelity to the redesign goals and processes. Ensure content accuracy, relevance, and adherence to brand guidelines. Implemen...

Senior Digital Editor, National Geographic Travel

Disney Entertainment Television

Washington, DC

Pitch and develop story ideas that resonate with our audience and align with our content strategy. Assign stories to freelancers by communicating appropriate story framing, story length, and deadlines.. Collaborate with photo edi...

Firewall Engineer Senior

Saic Motor

BELTSVILLE, MD

Build, design, test and deploy perimeter security systems. . Directs compilation of records and reports concerning perimeter operations and maintenance to analyze the performance of perimeter security systems. . Provides input to...

Senior Manager, Pharmacovigilance PV Operations, US - Remote

Biospace

Washington, DC

Act as a point of contact for AE Intake processes including training, controlled documents and systems for the MariTide (AMG 133) portfolio. Provide Safety Intake expertise and oversight for workflow management for Data Element St...

Marketing Senior Manager, US, Cardiovascular - (Remote)

Biospace

Washington, DC

Design and execute innovative health care professional promotional initiatives and tactics in alignment with brand strategic imperatives. Helping to guide strategic decisions and ensuring flawless execution of promotional campaign...

Mid-Senior Energy Transactions Associates

An International Law Firm

Washington, DC

We are looking for candidates who can and want to assume immediate responsibility and who are willing to work as an integral part of a high performing and collaborative team. Expected salary range is $345,000 to $370,000 depending...

Attorney-Adviser (Senior Counsel, Policy & Stra...

A Government Entity

Washington, DC

Participate in the development and implementation of the CFPB's and Enforcement's strategic plan and priorities within the designated markets. Identify emerging trends and priorities in designated markets and product areas within...

Senior Project Manager (DHS IT)

Omniscius Consulting

Washington, DC

Oversee the agile development process, ensuring timely delivery of software enhancements and compliance with project specifications. Coordinate with stakeholders across DHS entities to ensure project alignment with organizational...

Senior Oracle Database Administrator

Saic Motor

WASHINGTON, DC

Bachelors degree in an Information Technology, Engineering, or related field. 8+ years of experience supporting Middleware in Unix or Linux operating systems. Minimum 3-years hands-on experience installing and configuring and sup...

Active Directory Senior System Engineer

Saic Motor

WASHINGTON, DC

Analysis, design, testing and deployment of Active Directory, Entra ID, (formerly Azure AD), Entra ID Connect & Domain Controllers. Advanced knowledge of PowerShell scripting capability with an understanding cloud scripting. Tier...

Mid-Senior Energy Transactional Associates

An International Law Firm

Washington, DC

We are looking for candidates who can and want to assume immediate responsibility and who are willing to work as an integral part of a high performing and collaborative team. Expected salary range is $345,000 to $370,000 depending...

Zero Trust Senior Architect

Guidehouse

Washington, DC

Develop and implement cutting-edge Zero Trust architectural designs and strategies tailored to the unique needs and complexities of federal government environments. Lead the design and development of Zero Trust models encompassing...

Value and Access Senior Manager, Obesity

Biospace

Washington, DC

Support development of go-to-market strategy of pipeline assets globally including creation of strategy, payer research, pricing and contracting strategies, payer policy and partnerships Co-create reimbursement strategies with US...

Senior Fire Protection Engineer

Jacobs

Washington, DC

FPE or PE. TS Clearance....

Safety Statistician, Senior Manager

Amgen

Washington, DC

Represents the Biostatistics function and participates in multidisciplinary project team meetings; collaborates closely with other functional team members; incorporates knowledge of cross-functional areas to inform and provide sou...

Business Development Senior Manager - Alliance Management

Amgen

Washington, DC

Manages a portfolio of partnerships at all stages of their lifecycle. Identifies, understands, and ensures mechanisms are in place to manage differences between Amgen and partner (e.g. on partnership strategy, operating model, pro...

Combination Product Safety- Senior Manager

Amgen

Washington, DC

Assessment of potential impact of quality findings on patient/user safety for all Amgen clinical and commercial Combination Products and medical devices. Review of adverse event data to detect potential product quality issues for...

Business Development Senior Manager - Alliance Management

Biospace

Washington, DC

Manages a portfolio of partnerships at all stages of their lifecycle. Identifies, understands, and ensures mechanisms are in place to manage differences between Amgen and partner (e.g. on partnership strategy, operating model, pro...

Integrated Access Strategy Senior Manager

Biospace

Washington, DC

Support global launch activities for the top 10 markets including planning and updates of access materials for affiliates such as refinement of the Global Value Story and Objection Handler, pricing guidance materials, negotiation...

Combination Product Safety- Senior Manager

Biospace

Washington, DC

Assessment of potential impact of quality findings on patient/user safety for all Amgen clinical and commercial Combination Products and medical devices. Review of adverse event data to detect potential product quality issues for...

Safety Statistician, Senior Manager

Biospace

Washington, DC

Represents the Biostatistics function and participates in multidisciplinary project team meetings; collaborates closely with other functional team members; incorporates knowledge of cross-functional areas to inform and provide sou...

Clinical Research Senior Medical Scientist, Cardiovascular

Biospace

Washington, DC

Provide clinical/scientific input during the development and execution of olpasiran clinical trials. Interpret clinical trial data. Participate in safety assessments. Participate in interactions with regulatory agencies. Author st...

Senior Director, Biostatistics

Biospace

Washington, DC

Oversee large and/or complicated product(s) or indication(s), which may require overseeing other Global Statistical Lead(s). Develop, lead, and serve as the primary point of contact for the statistical program strategy for a portf...

Global Health Economics & Outcomes Research (HEOR) Senior Manager

Biospace

Washington, DC

Generating global-impact payer-relevant evidence, patient reported outcomes (PRO), clinical outcomes assessment strategy (COA) and evidence synthesis. Ensuring delivery of global materials to support Health Technology Assessment (...

Senior Procure-to-Pay Analyst

Costar Group, Inc.

Washington, DC

By equipping the brightest minds with the best resources available, we provide an invaluable edge in real estate.ROLE DESCRIPTION:At CoStar Group, we have consolidated traditional Procurement and Accounts Payable strategic and ope...

Senior Direct Mail Designer (FT WFH | Through Oct. 2024)

Brainstorm Creative Resources Inc.

Washington, DC

We are open to considering amazing designers living anywhere in the United States, but will be looking to identify someone who is comfortable working during typical east coast hours. The design work environment is Mac, and the fi...

Senior Manager, Payer Contracting

Biospace

Washington, DC

Manage the contract development process in conjunction with Amgens Market Access account executive, Law, Coverage & Pricing, and other customers. Create term sheets and complete request for proposals (RFPs) as needed to provide pr...