Search Results: 24 vacancies
...tenants on housing advocacy and tenant rights issues by providing education and technical assistance to the Community Tenants Association (CTA).
Status: Full-time, Nonexempt, Regular
Location: Chinatown neighborhood, San Francisco
Hours: Monday through Friday, 9:00a...
Suggested
Hourly pay
Full time
Temporary work
Flexible hours
Weekend work
Afternoon shift
Monday to Friday
...study documents to the TMF including performing periodic QC of assigned sections of the TMF and providing TMF support & guidance for CTA.
Assisting with study start-up activities including feasibility, site qualification, site selection, and site initiation.
Negotiating...
Suggested
Full time
...authorities to enable optimal clinical development and registration of novel drugs.
+ Author, review, and finalize relevant sections of IND/CTA filings as well as NDA/MAA/BLA submissions and respond to health authority questions related to these submissions.
+ Represent...
Suggested
...initiate protocol amendments as needed.
* Oversees aspects of study management and vendors to ensure high quality of data.
* Works with the CTA to ensure creation, tracking, distribution, and accuracy of meeting agendas and meeting minutes.
* Participates in the review/...
Suggested
Full time
...submissions for consistency and quality across regions, ensuring conformance to commitments made with various regulatory agencies (eg, IND/CTA commitments)
* Coordinate preparation of responses to queries from regulatory authorities
* Maintain up to date knowledge and...
Suggested
For contractors
...support investigational and marketing registration packages throughout the world and ensure timelines are met.
* Reviews sections of IND/CTA, BLA/MAA, and other global submission documents in support of clinical trials and marketing applications, and their amendments in...
Suggested
Full time
Contract work
Temporary work
Work experience placement
Local area
Shift work
3 days per week
...both the US and China and capitalizing on the strengths of each geographic location.
POSITION SUMMARY
The Clinical Trial Associate (CTA) / Senior CTA acts as a central contact for the designated clinical study team and in this key support role supports the team in the...
Suggested
Full time
...timely delivery of written reports for regulatory submissions.
Write, review, and finalize nonclinical PK sections of regulatory (IND/CTA) filings and contribute to clinical protocol development.
Requirements
A highly motivated individual with a PhD in...
Suggested
Local area
...submission standards (FDA, Health Canada, PMDA, CDE, EMA, ICH, GXP, eCTD, etc.), and industry trends for dossier preparation (i.e. IND/CTA/NDA/MAA/NDS).
* Significant track record in leading regulatory operations staff through major global submissions (NDA, MAA etc)
*...
Suggested
Full time
Temporary work
Flexible hours
...supervision, coaching, and motivation of team members.
Familiarity with Investigational New Drug (IND) or Clinical Trial Application (CTA) processes and expertise in regulatory filings.
Demonstrated quantitative and scientific thinker as evidenced by a strong...
Suggested
...experience with pharmaceutical regulatory submissions and product approvals, contributing to major regulatory filing(s) such as IND/CTA or NDA/BLA/MAA.
Extensive knowledge of FDA regulations and practices and ICH guidance as well as strong knowledge of global health...
Suggested
Worldwide
...intercompany and consolidation processes and procedures
Own the Consolidation Process and Tool, responsible for month end revaluations, CTA and FX gain/loss analysis
Manage a team of managed services staff, review, approve and monitoring the performance
Be a key...
Suggested
Full time
Local area
Remote job
...solutions to individual clinical study issues
+ Delegates and oversees the management of certain aspects of project management to COM or CTA CTA staff to ensure clinical studies at a project level are executed within specified time, quality and cost parameters.
**...
Suggested
...regulatory submissions to health authorities (HAs), including Investigational New Drug (IND)/Clinical Trial Applications (CTAs) IND/CTA amendments, Non-Disclosure Agreements (NDA)/Marketing Authorization Applications (MAA), Orphan Drug Application, Breakthrough Applications...
Suggested
Holiday work
Full time
Temporary work
...SUMMARY/JOB PURPOSE:
Responsible for managing and maintaining existing investigational new drug (IND) and clinical trial application (CTA) submissions and preparing amendments in compliance with guidelines and regulations. Coordinates, compiles, and tracks product...
Suggested
Holiday work
Contract work
Local area
Flexible hours
$60k - $110k
...Director of Regulatory Operations, you will be responsible for assembling, formatting, and publishing regulatory dossiers (e.g., IND, CTA, BLA, MAA) for global registration and lifecycle management submissions (e.g., supplements, amendments, variations) to meet corporate...
Holiday work
Full time
Local area
Remote job
...field of study
~4-8 years of experience in drug development (pharma/biotech) w/ 2-3 years of project management experience
~ IND/CTA and NDA/BLA development experience
~ Demonstrated leadership and ability to work effectively with project teams.
~ Ability to...
Permanent employment
...and 24 hours on weekends. Please see additional details with the attachment.
Second Opportunity:
Modalities: CT (neuro, body, CTA, MSK), US (body, OB-proficient to handle cases on call), MRI ( Neuro, Body, limited MSK- proficient to handle cases on call), Nuclear...
Hourly pay
Weekly pay
Locum
Flexible hours
Weekend work
Weekday work
...and governance meetings
Play a key role in planning, preparation, drafting and review of regulatory documentation, including IND/CTA/GMO/BLA/MAA, regulatory interactions, responses to queries from competent authorities, as required for investigational and registration...
Shift work
...with immunologic conditions continue to suffer – our goal is to fundamentally change the outcomes for these patients.
As a Sr. CTA, you will work closely with the Clinical Operations team to support the full scope of study activities, including site activation, patient...
Full time
Contract work
For contractors
3 days per week
