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senior manager, regulatory sciences (biotech/pharma)

Our biotechnology client has an immediate need for a Sr. Manager, Regulatory Science on a full-time basis in their Los Angeles location.  You will primarily support the US regulatory aspects of regulatory affairs for their lead product, research & summarize regulatory intelligence, provide regulatory input for regulatory submissions and work closely with colleagues to compile & review submissions for completeness and quality.

 

This position may manage employees of the department and is responsible for the performance management and hiring of any employees reporting to this role within that department.

 

Responsibilities:

  • FDA contact for assigned projects.
  • Participates in global regulatory team, study teams, and ad hoc meetings as a regulatory affairs representative.
  • Offer submission strategies and identifies potential regulatory risks.
  • Tactical support for the timely preparation, editing and review of submissions, including Health Authority Meeting Requests & Briefing Documents, IND/CTA amendments, NDAs/NDSs/MAAs and their respective amendments/supplements
  • Support creation of cover letters, forms, and other required documentation for applicable submissions including drafting of proposed US labels.
  • Liaises internally and externally on applicable submission documents including the uploading and routing of documents in EDMS and the review of documents.
  • Assist in the global strategy for potential new markets and regulatory intelligence for indications of interest.
  • Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
  • Provide interpretation of new regulations, guidance documents and directives; and advises on impact on internal programs.
  • Compile and maintain global regulatory documentation databases or systems.
  • Archive global submissions and regulatory correspondence.
  • Complete CTA Questionnaires for all studies on monthly basis.
  • Build and maintain spreadsheets that will calculate and organize business metrics as required.
  • Compose or update standard operating procedures, work instructions, or policies as needed.
  • Support Global MAA with Regional Partners
  • Manage ex-US CTAs through local regulatory consultants
  • Excellent listening and communication skills, with an ability to accept direction and feedback

Required Skills:

  • Minimum of Bachelor’s degree
  • Degree(s) should be in Life Sciences/Health Related Sciences from an accredited college or university
  • Had prior US Regulatory Lead, FDA contact, or directly related experience, preferably in the oncology therapeutic area

 

 

Filed Under: Uncategorized

Principal Clinical Data Manager-biotech/pharma (oncology)

THIS IS A REGULAR FULL TIME ROLE THAT INCLUDES FULL BENEFITS PACKAGE, BONUS POTENTIAL AND POSSIBLE STOCK OPTION

THIS ROLE IN ONSITE AT THE CLIENT OFFICES IN EITHER WEST LA OR SOUTH SF

NO REMOTE OR TELECOMMUTE OPTION FOR THIS ROLE

 

Primary Objective of Position

 

Principal Clinical Data Manager, Clinical Data Management, is  responsible for leading study data management activities including, but not limited to, coordination of CRF design, development, review and sign off ; Reviews and approves CRO generated Data Management documents,  coordinates database live and close out activities with the CRO,  provides guidance to CRO to manage query flow and implements quality control plan.  The individual may participate in reviewing vendor audit plan and statistical analysis plan as needed;   may participate in vendor qualification and selection as appropriate, and participates in monitoring vendor performance

 

Major Duties/Responsibilities

 

Reviews listings to identify data discrepancies and tracks resolutions

 

Works with Study team to design mock CRFs based on the protocol

 

Leads database design, implementation and testing activities

 

Supervises all Data Management deliverables and associated timelines with the CRO to ensure a quality database lock

 

Co-ordinates with Clinical Operations, Biostatistics, Statistical Programming, Safety and other departments, as needed, to resolve data issues

 

Skills & Abilities

 

Excellent organizational skills and ability to prioritize tasks

 

Must be able to work under tight timelines

 

Possess excellent communication skills

 

Anticipates change and reacts quickly and intelligently to accommodate business needs.

 

Physical Demands

 

The physical demands described are representative of those that must be met by an employee to successfully perform the primary functions of this position.

 

The physical demands of the office are normally associated with extended amounts of time in front of a computer. While performing the duties of this job, the employee is frequently required to stand, walk, and sit.   May involve travel up to 10%

 

Education & Professional Experience

 

Required:

 

Bachelor’s Degree in a biological sciences or other medically related areas

 

Minimum of 7 years of data management experience in the biotechnology/pharmaceutical industry

 

Familiarity with data management software (e.g. Medidata, Oracle Clinical)

 

Working knowledge of coding dictionaries – MeDDRA and WHODRUG

 

Preferred:

Knowledge of Oncology clinical trials

 

Nursing background

 

Vendor management experience

 

Familiarity with SAS

 

 

 

 

Filed Under: CDM (Clinical Data Manager)

Senior Business Analyst

Sr. BUSINESS ANALYST-Woodland Hills, CA.

 

DESCRIPTION

The Sr. Business Analyst is responsible for reviewing assigned business processes from end-to-end to identify and address operational, financial and technological risks and identify opportunities to improve efficiency. This position report to Director of Software Engineering. Responsibilities will include a full range of activities from leading small to mid-size projects to assisting other Business Analyst and project managers on larger more complex projects related to operational business functions that affect team members and providers at the market level. You will interview stakeholders, write agile stories, guide the development team on-shore and off-shore and work with other business analysts. This is full time, non-exempt position.

DUTIES & RESPONSIBILITIES

  • Implement and represent client policy enthusiastically
  • Represent client professionally and ethically to internal and external stakeholders
  • Work effectively with senior management
  • Support system conversions, upgrades, enhancements
  • Provide project level analysis – producing required project analysis documentation (business requirements, scope matrix, agile stories and use cases)
  • Serve as a liaison between Operations and IT to assist or gather business requirements needed for system modifications, enhancement and implementations
  • Coordinate QA and User Acceptance Testing.
  • Provide leadership to team members and peers by collaborating with others; articulating ideas and viewpoints to senior management, peers and others; identifying and initiating projects; managing resources; driving the resolution of issues; and holding self and team accountable for results

EXPERIENCE & QUALIFICATIONS

  • Bachelor’s or master’s degree in related technical field
  • Minimum 6+ years of business systems analysis experience working on Agile software development efforts
  • Experience in Jira, Confluence and Visio
  • A good understanding of SDLC process
  • Schedule and facilitate Joint Application Development (JAD) sessions
  • Translate high level requirements into User Stories/Detailed Requirements
  • Work as a liaison between business and delivery teams in all phases of development from product definition to deployment
  • Perform feasibility analysis, scope projects, prioritize deliverables, recommend alternative solutions and project strategies, and engage in negotiations
  • Ability to demonstrate Process Flow Diagrams using UML concepts
  • Ability to multi task and handle multiple projects at anytime
  • Willingness to review and understand projects handled by various project teams
  • Create a road map to become a Subject Matter Expert (SME)
  • Willingness to work with Onsite and Offshore development teams
  • Understand industry trends and best practices in the business that can be applied to system design and process improvement.
  • Monitor project progress by tracking activity, resolving problems, and meeting all project deliverables as planned
  • Demonstrate good communication and relationship skills with Internal IT, Business Teams and External Vendors
  • Provide support to QA Team and Business Users during QA and UAT phase of the projects
  • Ability to estimate projects and timelines
  • Must have experience working on large scale projects as well as handling day-to-day operational requests from the business
  • Experience in ERP development and implementation is a plus.
  • Must have strong project management, strong relationship building skills & communication skills
  • Data analysis proficiency is a plus.
  • Able to thrive in a fast paced environment
  • Good decision making and problem solving ability
  • Works well in teams and has the ability to work independently with little or no supervision

BENEFITS & COMPENSATION

For qualifying employees, benefits include medical, dental, vision, life insurance, flexible spending program, 401K, earned paid vacation, sick and holiday pay, educational assistance program and corporate discount programs.

 

Filed Under: PM/BSA

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13636 Ventura Blvd. Suite #425
Sherman Oaks, CA. 91423
818.762.0800
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