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POSITION SUMMARY: The Submission Manager will be an integral member of the Global Regulatory Dossier Management Group.

On a daily basis, the Submission Manager will manage activities associated with generating regulatory submissions, including identifying and sourcing submission content, managing and planning submission timelines and projects, and utilizing a wide array of document management, authoring, and publishing tools.

The Submission Manager will also utilize the Common Technical Document (CTD) and the eCTD, and all processes surrounding this capability.

Working closely with the Regulatory Leads, the Submission Manager will have an opportunity to develop a broad base of skills in both Regulatory Affairs and submission management.

DUTIES & RESPONSIBILITIES: Plan and manage Regulatory submissions, working with Regulatory Leads to develop and submit filings according to agreed upon processes and timelines.

Drive existing submission processes on multidisciplinary submission teams; develop and implement process change under the direction of Regulatory management.

Identify issues that may delay product or project and recommend appropriate action.

Manage generation and compilation of Regulatory sections of submissions using electronic document and publishing technology.

Apply quality control processes and engage in lifecycle management of submissions to ensure document integrity.

Prepare and maintain templates that meet Regulatory electronic submission standards.

Assist in development and maintenance of our electronic submission capability at Millennium, representing the Regulatory business function on technology teams.

BASIC QUALIFICATIONS: Minimum of 4 years of experience within the pharmaceutical industry and strong submission management and/or project management experience is required.

Skill in using desktop applications and proficiency in computer systems and procedures is required.

PREFERRED QUALIFICATIONS: Experience in preparing regulatory submissions (e.

g., investigator documentation, protocol amendments, etc.) is highly desired.

Experience in a Regulatory Submissions organization along with a working knowledge of drug development process is strongly desired.

6198BR – Manager, Regulatory Submission Management Job in Cambridge 02139, Massachusetts US

Click here to applyConverteam is the industry leader in electrical engineering, systems integration and the design and manufacturing of high power motors, generators, drives and drive systems.

By using our extensive project management experience and superior technology, we specialize in providing customized solutions to convert electrical energy into productive performance.

With more than 5000 employees worldwide, we operate in four core markets; marine and offshore, oil and gas, process industries and power generation as well as addressing many niche markets.

We cover a broad scope of offer from design to Turnkey System Installation & Commissioning, complemented with a complete range of services.

PRIMARY OBJECTIVE OF THE POSITION: The Senior Engineer is responsible for planning, directing, supervising and executing complex development engineering projects requiring experience in the application of advanced engineering knowledge.

The Senior Engineer must apply fundamental engineering principles and experience to solve technical design problems and develop new product solutions.

Responsibilities include the ability to develop budgets, determine manpower and technical resources, coordinate assignments of engineers and other support personnel, and provide engineering documentation of projects and processes.

MAJOR AREAS OF ACCOUNTABILITY

1. Establish project plans for product development consistent with the overall company strategic plan.

2. Determine project schedules to complete projects in required time3 Select materials and purchased components to best meet customer requirements at the lowest cost4 Provide input to management for financial planning, capital planning, and product development5 Provide effective project management for product development6 Specifications, Material Specifications, and project reports7 Provide direction to engineers, drafters, and other support personnel as required to successfully complete projects8 Provide technical support to other departments as required resolving technical issues to meet special customer requirements9 Review manufacturing methods and determine the most efficient designs for manufacturability.10. Provide technical direction in product development and make technical decisions based on sound engineering practice.11. Able to perform and understand FEA analysis and develop design roles and guidelines.

GENERAL EXPECTATIONS

1. Demonstrate on-going commitment to continuous improvement2 Determine and implement process improvements that enhance company profitability and responsiveness to customers3 Demonstrate ability to understand, evaluate, and solve complex issues of technical and commercial content.

KNOWLEDGE, SKILLS, AND ABILITIES

1. BS degree in mechanical engineering required2 7-10 years experience in the design or development of large motors and/or generators, or equal level of product complexity3 Knowledge of documentation requirements of ISO 90014 Knowledge and understanding of engineering operating systems within the department and understanding of how engineering interfaces with other departments5 Working knowledge of Microsoft office products, Word, Excel, etc6.

Ability to communicate effectively both verbally and in writing both internally & with customers7.

Physical ability to travel freely within manufacturing and office facilities.

This requires climbing stairs and moving over, around, and about shop machinery8 Physical ability to lift and carry 25 pounds.

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Sr. Mechanical Engineer Job in Minneapolis 55413, Minnesota US

Our Hiring Company, a WORLD LEADING supplier of complex cooling and air conditioning systems for railway, special vehicles, buses, and off highway vehicles is searching for a SR. MANAGER OF PRODUCT DEVELOPMENT for their West Michigan facility.

Qualifications for the successful candidate will include: Bachelors Degree in Mechanical Engineering Minimum of four years Product Development Engineering experience in the definition and design of engine cooling and HVAC system spec sheets, system specs and design activities Manages the Product Engineering group, supervises all project launch activities and project leaders Extensive knowledge of thermodynamics, heat exchange and fluid mechanics Proven ability in engine cooling and HVAC Hands-on experience in the design of heat exchangers, engine cooling and HVAC units Must have experience managing a team of engineers and designers Competent knowledge and understanding of CATIA V5 Strong project management experience Excellent interpersonal skills with both internal & external customers Proficiency in the German language a Huge Plus ! Able to balance the Product Development team and individual responsibilities – strong desire to put the success of the team above their own interests.

Must be a US Citizen, required Interested and Qualified candidates please send your resume in WORD format to info [at] jblresources [dot] com For other exciting and rewarding career opportunities at JBL Resources, please visit our Website: http://www.jblresources.com .JBL Resources is proud to have earned the reputation of being the chosen provider of premier talent to the most respected companies and organizations Nationwide.

JBL Resources’ superior and quality-focused approach is exhibited in each of our valued partnerships, whether with an individual professional or with our client companies.

JBL Resources looks forward to earning and retaining your trust and confidence.

We invite you to contact us and see the difference partnering with a firm who keeps its integrity and priorities where they belongon YOU!

Sr. Manager of Product Development – 1333 Job in Grand Rapids 49505, Michigan US