Regulatory Affairs Associate - MedFocus (California)

Regulatory Affairs Associate - MedFocus (California)
Apply to jobs now hiring in California today!

Job Description:

A Regulatory Affairs Associate is needed for a 6-month contract position at major pharma company in Northern California.

Duties: The Associate, Regulatory Affairs is responsible for the coordination, preparation and submission of a variety of regulatory submissions including INDs, CTAs, BLAs and NDAs to regulatory authorities.

Responsibilities:

* Attend project team meetings across functional areas

* Prepare, submit, and maintain domestic and international regulatory filings, both pre and post approval

* Assist with and coordinate meetings with regulatory authorities

* Assist with development strategy

* Support the filing, review, and approval of global license applications

* Support for multiple projects if necessary

* Other duties as assigned

Education and Experience:

* Bachelor’s Degree

* 2-3 years industry experience in the pharmaceutical or biotechnology industry

* Proven ability to manage critical projects with a minimum of supervision

* Prior experience compiling filings for FDA submissions is required with the ability to successfully manage projects to deadlines

* Prior experience in a product development role

* Proficient with computer and standard software programs

* Strong interpersonal and communication (written and verbal) skills

* Effective task planning and coordination abilities

* Demonstrated good judgment

* Capable of working with an interdisciplinary team

Please send resume to jobs@inventivhealth.com

*Min Salary:* $0.00

*Max Salary:* $0.00

*State:* CA

Job Listing

Show more

Popular posts from this blog

Local Driver - Home Nightly - HD Supply (California)

Company Overview HD Supply (www.hdsupply.com) is one of the largest industrial distributors in North America. The company provides a broad range of products and value-add services to approximately 300,000 customers with leadership positions in maintenance, repair and operations. Through 44 distribution centers, in the U.S. and Canada, the company's approximately 5,500 associates provide localized, customer-driven services including will call, direct-ship options, diversified logistics and innovative solutions that contribute to its customers' success. With an active commitment to the communities in which we operate, HD Supply associates are part of a thriving organization that supports the virtues of wellness, diversity and inclusion – all of which are top priorities for the company. Equally as important is empowering our associates to grow professionally while providing competitive benefits and compensation. If you’re ready to find a rewarding career and achieve your full po
Read more

Senior Assessment Specialist - English Language Arts - Pearson (California)

Senior Assessment Specialist — English Language Arts - ( 2107371 ) Description We are the world’s learning company with more than 24,000 employees operating in 70 countries. We combine world-class educational content and assessment,powered by services and technology, to enable more effective teaching and personalized learning at scale. We believe that wherever learning flourishes so do people. Responsibilities: Development and review of English Language Arts items for large-scale assessments; evaluation of passages for use in large-scale assessments; interpretation of blueprints, and the construction of operational and field tests. + Involvement in standards interpretation, application of best practices in item and test development, facilitation of committees, and alignment determinations. + Position requires skills in grammar, editing, and communications with internal and external customers. + Facilitate, maintain and oversee content development in English Language Arts, Re
Read more

Medical Claims Adjuster - Robert Half Office Team (California)

Medical Claims Adjuster - Robert Half Office Team (California) Apply to jobs now hiring in California today! Immediate Opening for a Medical Claims Adjuster. Apply Now! Robert Half Healthcare Practice is looking for a Medical Claims Adjuster for a well-known client on the East Bay. This role will be responsible for: * Claims pre-processing, matching, batching, coding, and entering invoices * Posting and reconciling batches * Examine and enter basic claims for appropriateness of care * Process claims for multiple plans * Approving, pending, or denying payments according to the accepted coverage guidelines For immediate consideration, please send your resume as a Word Document to Neha Potdar with Robert Half Healthcare Practice at neha.potdar@officeteam.com or call 510-763-2256xt 21625 Skills and Qualifications: * High school diploma * Knowledgeable in Medical coding (including CPT4, HCPCs, ICD-9) with EMR experience * Proficient in the operation of MS Office Suit
Read more

Manager, Financial Services - Prudential - Sherman Oaks, CA

Manager, Financial Services - Prudential - Sherman Oaks, CA Apply to jobs now hiring in California today! At Prudential, we measure our long-term success on our ability to deliver value for shareholders, meet customer needs, and attract and develop the best talent in the industry. We offer an inclusive work environment where financial professionals and managers can develop to their full potential and strengthen their communities. Prudential Advisors is presently looking for a Manager, Financial Services in Sherman Oaks, CA. Prudential Advisors is a nationwide sales organization. The Manager, Financial Services (MFS) is responsible for the recruitment, selection, development, retention, success, and supervision of new and experienced financial professionals. The MFS is the immediate supervisor for the organization's approach to a relationship based, life cycle, sales and advice process in selling insurance and financial products. Key aspects of this approach include: Tra
Read more

Key Holder - Boot Barn - Temecula, CA

Image
Key Holder - Boot Barn - Temecula, CA Apply to jobs now hiring in California today! Key Holders are responsible for providing an outstanding customer experience to all Boot Barn customers. They embody the Boot Barn mission, vision and values in all they do by developing selling and service skills, product knowledge, merchandising and visual presentation skills and point-of-sale proficiency. Key Holders partner with the management team to attain sales goals, assist with staff development, and all store operations. Essential Job Functions By your actions foster a service and selling culture, exceed customer expectations and build consumer relationships that will be enduring Ensure customers receive the highest level of service through creating an engaging customer centric selling and service environment, accurate product knowledge, maintain SSC merchandising standards, and all other components of customer service Develop product knowledge expertise for our product categories
Read more