http://www.stryker-careers.com/feeds/clinical-research-NJ-jobs/ Custom RSS Feed for clinical-research-NJ-jobs Fri, 24 May 2013 17:34:46 GMT en-us /sites/stryker/images/stryker_banner.jpg http://www.stryker-careers.com/feeds/clinical-research-NJ-jobs/ 720 Requisition ID:21995BR Job Title:Clinical Study Manager Division:Spine Business Unit:U.S. Business Function:Clinical Affairs Business Sub Function:Clinical Research Country:United States State:NJ City:Allendale Shift:1st Job Description:Job Summary
Manage multi-center clinical trials from start up to close out, in the U.S. or O.U.S. as applicable. For IDE/PMA studies, contribute to FDA approval process. Participate in the development /implementation/management of registries or other post approval/marketing activities as needed.

Essential Duties & Responsibilities

- Write Investigational Plan (including CRFs, labeling, etc.), with support of other depts, and consultants (e.g., statisticians, surgical advisory board, radiologists, etc.)

- Participate in labs to develop surgical technique guide(s)

- Compile Investigator brochure materials

- Prepare IRB submission materials

- Write Clinical Trial Plan, and develop study admin materials

- Investigator/Study Coordinator training (trial and regulatory requirements)

- Gather and report on study progress data to management

- Manage device accountability, authorize shipment of implants and instruments

- Monitor study data collection and provide feedback to sites and monitors

- Correspondence to Investigators, Study Coordinators and Reps

- Coordinate patient recruitment activities

- Plan Investigator Meetings/training updates/communication

- Coordinate site closeout activities with monitors, data management, etc.

- Plan for final data collection, database cleaning, and archiving of data

- For IDE/PMA studies actively participate in submissions and review processes.

- Prepare Clinical Evaluation Plans and Reports as required under the EU MDD.

- Participate in New Product Development teams as a clinical representative; responsible for the Clinical Plan.

- Responsible for the guidance and development of the Clinical Research Associate.

Qualifications / Work
Experience Required

- Minimum of 3 -5 yrs experience in Clinical Research or equivalent experience

- Preferably 2-3 yrs experience in device monitoring (orthopedic/spine experience preferred)

- Proficiency with software applications for PC

- Excellent project planning, time management and communication skills (written, verbal)

- Able to work with minimal supervision, set priorities and be flexible within a fast-paced environment Qualifications/Work Experience: Percent Travel Required:25%]]>Sat, 18 May 2013 05:31:00 GMThttp://www.stryker-careers.com/job/Allendale-Clinical-Study-Manager-Job-NJ-07401/2362624/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.stryker-careers.com/job/Allendale-Clinical-Study-Manager-Job-NJ-07401/2362624/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Requisition ID:22797BR Job Title:Research Engineer Division:Reconstructive Business Unit: Business Function:Engineering Business Sub Function: Country:United States State:NJ City:Mahwah Shift:1st Job Description:Develop and apply innovative, clinically relevant evaluation methodologies to characterize orthopaedic device / bone interaction using FEA and physical testing. Direct responsibility performing testing and analysis including protocol development, test and analysis execution, data reduction, and interpretation of results. Document results through internal reports, journal publication and presentation as necessary.
Candidate must have a solid background in biomechanics, strong experience in physical testing and analyitical prediction and a demonstrated ability to have successfully validated analyitical models through physical testing.

Education:
Masters / PhD in Mechanical Engineering or Biomedical Engineering with emphasis on mechanical.

Qualifications and Work Experience:

Finite element analysis experience required.
Physical benchtop test experience equired.
Two years work experience desired.
Demonstrated ability to conduct both physical and virtual biomechanical research and analysis.
Demonstrated creative problem solving skills.
Demonstrated inter-personnel, verbal and written communication skills.
Medical device industry experience desired.
ANSYS, LSDyna and ProE experience desired.
Experience participating in collaborative research programs.
Demonstrated strong project management experience.

Essential Duties and Responsibilities:
Execute finite element analysis of monolithic and multi body medical devices.
Evaluate analyitical results and recommend design changes based on characterization.
Develop new analysis techniques for evaluation of new materials, coatings and composite devices.
Perform detailed literature searches as needed to provide a basis for analysis and physical test assumptions.
Execute all aspects of physical testing including protocol development, test execution and evaluation of results.
Review, select and coordinate proposals for FEA and physical test related research at outside universities and laboratories. Qualifications/Work Experience: Percent Travel Required:<15%]]>Thu, 09 May 2013 02:59:00 GMThttp://www.stryker-careers.com/job/Mahwah-Research-Engineer-Job-NJ-07430/2422492/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.stryker-careers.com/job/Mahwah-Research-Engineer-Job-NJ-07430/2422492/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Requisition ID:24290BR Job Title:Senior Research Engineer Division:Orthopaedics Business Unit:- Business Function:Engineering Business Sub Function: Country:United States State:NJ City:Mahwah Shift:1st Job Description:Stryker Corporation is a global medical technology company with over $9B in revenue. Taking great pride in developing our employees, Stryker was named to Fortune’s “Top 100 Companies to Work for” (again!) in 2012!

The Senior Research Engineer provides engineering and material solutions to unmet clinical and business needs. He or she works closely with other team members both within and outside of Department to identify and overcome technical challenges that hinder the full business growth potential of bearing related product lines. This position possesses a thorough understanding of engineering design principles and material processing skills and applies this understanding towards solving practical problems. Basic project management skills are also utilized in implementing a complete battery of tests necessary to support the proof of concept, operations process validation and regulatory submission. This position serves as a mentor to other Engineers and requires minimal supervision.

Essential Duties & Responsibilities
(detailed descriptions)

- Identify and develop new processing techniques for materials and implant constructs to overcome current material/processing limitations

- Coordinate with internal and external collaborators, suppliers and vendors to bring state-of-the-art materials/engineering solutions to orthopaedic applications.

- Generate prospective engineering project plans including test protocols to validate proof-of-concept and to support operations process validation and technology transfer to production

- Generate technical memos and reports to a level of detail as required by the audience, up to and including that necessary to support a regulatory submission

- Support Business Units, Operations, Regulatory Affairs and Quality Assurance on an as-required basis

- Lead project teams as needed

- Mentor other engineers in best practices, industry trends and skill development

Education and Qualifications:

Bachelors degree in a scientific discipline, minimum; MS or PhD degree preferred


- 5+ years experience in mechanical, materials or biomedical engineering

- Demonstrated creativity and problem-solving skills

- Demonstrated project management skills

- Demonstrated verbal and written communication skills

- Demonstrated inter-personal skills

- Demonstrated ability to lead project teams

- Ability to mentor and develop others Qualifications/Work Experience: Percent Travel Required:10%]]>Sat, 18 May 2013 00:00:00 GMThttp://www.stryker-careers.com/job/Mahwah-Senior-Research-Engineer-Job-NJ-07430/2605047/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.stryker-careers.com/job/Mahwah-Senior-Research-Engineer-Job-NJ-07430/2605047/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Requisition ID:20484BR Job Title:Senior Project Engineer (Specialty Instruments) Division:Orthopaedics Business Unit:U.S. Business Function:Engineering Business Sub Function:Product Engineering Country:United States State:NJ City:Mahwah Shift:1st Job Description:Lead complex teams to advance assigned continuous improvement projects. Serve as a project mentor to other engineers under minimal supervision.

- Direct and manage the workflow of engineers within the scope of assigned projects.

- Interface with clinical advisors to gather input for design and evaluation of design improvements.

- Manage design control and risk management updates.

- Oversee teams to ensure project plans adhere to agreed upon timelines and are within the procedural guidelines.

- Lead and participate on cross-functional teams to address design issues and maintain existing designs.

- Utilize advanced knowledge of the surgical procedure and relationships with clinical advisors to develop innovative solutions to solve problems and satisfy customer needs.

- Mentor other engineers in project management best practices and technical expertise. Qualifications/Work Experience:5+ years of product development experience in the medical device industry or equivalent Demonstrated ability to lead complex product development initiatives from concept through release Demonstrated ability to apply design controls within a regulated industry Demonstrated ability to achieve work objectives both independently and as a leader/member of a work team Demonstrated experience with a parametric CAD design package. Prefer Pro/Engineer Percent Travel Required:<5%]]>Sat, 04 May 2013 02:59:00 GMThttp://www.stryker-careers.com/job/Mahwah-Senior-Project-Engineer-Job-NJ-07430/2066209/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.stryker-careers.com/job/Mahwah-Senior-Project-Engineer-Job-NJ-07430/2066209/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Requisition ID:19663BR Job Title:Senior Project Engineer Division:Reconstructive Business Unit:U.S. Business Function:Engineering Business Sub Function:Product Engineering Country:United States State:NJ City:Mahwah Shift:1st Job Description:Lead complex teams to advance assigned projects through the development process to market launch. Serve as a project mentor to other engineers under minimal supervision.

- Direct and manage the workflow of engineers within the scope of assigned projects.

- Interface with clinical advisors to gather input for design and evaluation of new products. This includes organizing and managing cadaver labs and consultant panel meetings.

- Manage the design control creation through the New Product Development Process (NPDP). Work with Program Managers and oversee technical teams to ensure project plans adhere to agreed upon timelines and are within the scope of the NPDP guidelines.

- Lead and participate on cross-functional design teams to develop new product, address design issues, and maintain existing designs.

- Utilize advanced knowledge of the surgical procedure and relationships with clinical advisors to develop innovative solutions to solve problems and satisfy customer needs.

- Establish and maintain relationships with key design consulting groups in order to recognize and anticipate industry trends and user needs.

- Mentor other engineers in project management best practices and industry trends. Qualifications/Work Experience:5+ years of product development experience in the medical device industry or equivalent Demonstrated ability to lead complex product development initiatives from concept through release Demonstrated ability to apply design controls within a regulated industry Demonstrated ability to achieve work objectives both independently and as a leader/member of a work team Demonstrated experience with a parametric CAD design package. Prefer Pro/Engineer Percent Travel Required:10-20%]]>Sun, 19 May 2013 02:59:00 GMThttp://www.stryker-careers.com/job/Mahwah-Senior-Project-Engineer-Job-NJ-07430/2352433/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.stryker-careers.com/job/Mahwah-Senior-Project-Engineer-Job-NJ-07430/2352433/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Requisition ID:23005BR Job Title:VP R&D Division:Reconstructive Business Unit:Knees Business Function:Research & Development Business Sub Function:General/Other: R&D/Science Country:United States State:NJ City:Mahwah Shift:1st Job Description:Job Summary

Responsible for leading the efforts of the advanced technology development and product development support functions with minimal supervision. This will include developing resource models, helping with the setting of development commitments and the execution of those commitments. Work closely with the leadership of the Hip, Knee and Shoulder business units while providing prototyping, testing, project management support to the product development functions resident in said business units.

Qualifications and Work Experience Required


- 10+ years of leadership experience in the areas of product and technology development, preferably in the medical device industry or equivalent.

- Prefer expertise in the function, clinical issues and performance requirements of Orthopaedic implants.

- Demonstrated experience leading complex product development initiatives from concept through release.

- Expertise in the management and refinement of design controls with in a regulated industry.

- Demonstrated Leadership Capabilities

- Demonstrated Communication and Relationship Skills with a demonstrated ability to motivate professionals at all levels of the organization.

- Experience managing directors and managers with direct reports. This includes developing, recruiting and team building.

- Demonstrated experience in management of expense budgets.

Essential Duties & Responsibilities


- Ensure product and technology superiority relative to all competition in the marketplace.

- Ensure overall quality, safety & efficacy of the output of the NPDP and subsequent product modifications.

- Develop and evolve the organizational architecture to maximize productivity.

- Maximize the connection of the R&D organization to its key partners, QA, Business units, etc.

- Provide direction towards the development and management of department expense budgets and spending such that resources optimally align with the department mission.

- Oversee management of resource planning tools to ensure that only properly resource projects are admitted to the active product development portfolio.

- Oversee the product development design standards and practices.

- Work in collaboration with key surgeon consultants to ensure the clinical relevance of the R&D activities.

- Participate with senior management to identify strategic opportunities and product line strategies.

- Manage R&D's employee development and succession planning activities.

- Coach and counsel direct reports in the development of their teams and own personal development

- Mentor Engineering Leadership team

Manages:

(Titles of direct reports)
Senior Dir, R&D Operations
R&D Technical Director
Research Director
VP, Recon Tech Development
Executive Assistant

Education and Special Training Required

Bachelor's degree in a science, Prefer Masters Degree in a technical discipline. Prefer Mechanical or Biomedical Engineering Qualifications/Work Experience: Percent Travel Required:20-30%]]>Mon, 20 May 2013 03:00:00 GMThttp://www.stryker-careers.com/job/Mahwah-VP-R&D-Job-NJ-07430/2443772/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.stryker-careers.com/job/Mahwah-VP-R&D-Job-NJ-07430/2443772/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Requisition ID:23610BR Job Title:Project Engineer Division:Reconstructive Business Unit: Business Function:Engineering Business Sub Function:Biomedical Engineering Country:United States State:NJ City:Mahwah Shift:1st Job Description:Perform implant and instrument design work. Actively participate on, and sometimes lead, multifunctional teams to advance assigned projects through the development process and launch into the market.


- Model and detail implant and instrument designs utilizing Pro/Engineer design software.

- Develop prototypes for design verification and validation.

- Utilize/Manage design controls within the New Product Development Process (NPDP).

- Interface with clinical advisors to gather input for design and evaluate new products.

- Develop verification and validation protocols and technical reports.

- Actively participate on, and sometimes lead, cross-functional design teams to develop new product, address design issues, and maintain existing designs.

- Utilize knowledge of the surgical procedure in order to develop innovative solutions to solve / satisfy customer needs.

OtisMed:

- Interact regularly with surgeons to understand and collect their feedback.


- 2+ years of product design experience in the medical device industry or equivalent

- Demonstrated familiarity of design controls within a regulated industry

- Demonstrated experience in the medical device industry

- Demonstrated ability to be a self-starter, have a hands-on approach and capability to work independently

- Demonstrated experience with a parametric CAD design package. Prefer Pro/Engineer

Bachelor’s degree in a science, Prefer Mechanical or Biomedical Engineering Qualifications/Work Experience: Percent Travel Required:10%]]>Wed, 22 May 2013 02:59:00 GMThttp://www.stryker-careers.com/job/Mahwah-Project-Engineer-Job-NJ-07430/2503399/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.stryker-careers.com/job/Mahwah-Project-Engineer-Job-NJ-07430/2503399/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Requisition ID:24355BR Job Title:Project Engineer Division:Reconstructive Business Unit: Business Function:Engineering Business Sub Function:Mechanical Engineering Country:United States State:NJ City:Mahwah Shift:1st Job Description:Perform implant and instrument design work. Actively participate on, and sometimes lead, multifunctional teams to advance assigned projects through the development process and launch into the market.


- Model and detail implant and instrument designs utilizing Pro/Engineer design software.

- Develop prototypes for design verification and validation.

- Utilize/Manage design controls within the New Product Development Process (NPDP).

- Interface with clinical advisors to gather input for design and evaluate new products.

- Develop verification and validation protocols and technical reports.

- Actively participate on, and sometimes lead, cross-functional design teams to develop new product, address design issues, and maintain existing designs.

- Utilize knowledge of the surgical procedure in order to develop innovative solutions to solve / satisfy customer needs.


- 2+ years of product design experience in the medical device industry or equivalent

- Demonstrated familiarity of design controls within a regulated industry

- Demonstrated experience in the medical device industry

- Demonstrated ability to be a self-starter, have a hands-on approach and capability to work independently

- Demonstrated experience with a parametric CAD design package. Prefer Pro/Engineer

Bachelor’s degree in a science, Prefer Mechanical or Biomedical Engineering Qualifications/Work Experience: Percent Travel Required:15%]]>Fri, 17 May 2013 00:00:00 GMThttp://www.stryker-careers.com/job/Mahwah-Project-Engineer-Job-NJ-07430/2603144/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.stryker-careers.com/job/Mahwah-Project-Engineer-Job-NJ-07430/2603144/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Requisition ID:24223BR Job Title:Associate Director, Global Brand Hip Marketing Division:Reconstructive Business Unit: Business Function:Marketing Business Sub Function:Brand/Product Marketing Country:United States State:NJ City:Mahwah Shift:1st Job Description:Lead a team that drives product marketing strategies and programs consistent with overall business unit objectives in a portfolio of products utilizing traditional and innovative brand management, product marketing approaches, tools and methodologies.


- Provide overall management and leadership to Brand Marketing team.

- Drive business initiatives through direct reports

- Develop product and/or brand marketing strategies within the Brand/Product Segment product lines.

- Develop and execute the portfolio product/marketing strategies to achieve stated revenue, profitability and market share objectives.

- Work with Business Intelligence function to evaluate trends in assigned segments, as well as new (but related) markets, to determine segment penetration opportunities and strategies.

- Work with outside agencies/organizations to benchmark marketing program offerings and bring best demonstrated practices in-house.

- Establish consistent positioning image throughout product lines, promotional materials and events.

- Drive the product/marketing message through all communication channels by partnering with internal and external communication resources and functions.

- Build on existing Brand core competencies generate new product concepts and manage/maintain a healthy product development pipeline

- Work with internal and external clinical and scientific advisors, including Stryker’s surgeon consultant base, to create and drive a research matrix which supports brand value propositions and claims.

- Collaborate with field sales management, consulting surgeons and patients to validate, deliver and evaluate marketing strategies and programs.


- 5+ years of experience managing professional staff.

- 7+ years in a Marketing or Engineering function, including direct product management experience.

- Prefer experience in or direct exposure to the healthcare product or medical device industry.

- Demonstrated ability to lead both direct and indirect teams

- Demonstrated ability to build and maintain key business relationships, on a global basis

- Demonstrated ability to work both collaboratively and independently in a cross-functional and team-oriented environment

- Demonstrated verbal and written communication skills; ability to interact effectively both one-on-one and in groups

- Demonstrated analytical skills

- Demonstrated ability to deliver results on multiple, complex projects

- Demonstrated ability to develop and execute on a strategic plan directly linked to broader business/divisional goals, on both a regional and global basis.

- Demonstrated ability to understand and work across different cultures and market places to drive a global business/strategic plan for the brand/product segment.

- Demonstrated capability of building appropriate relationships and working with consulting surgeon base. Qualifications/Work Experience: Percent Travel Required:30%]]>Fri, 24 May 2013 00:00:00 GMThttp://www.stryker-careers.com/job/Mahwah-Associate-Director%2C-Global-Brand-Hip-Marketing-Job-NJ-07430/2616531/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.stryker-careers.com/job/Mahwah-Associate-Director%2C-Global-Brand-Hip-Marketing-Job-NJ-07430/2616531/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Requisition ID:23832BR Job Title:Chief Engineer, Biomaterials Division:Orthopaedics Business Unit:Hips and Knees Business Function:Engineering Business Sub Function:Biomedical Engineering Country:United States State:NJ City:Mahwah Shift:1st Job Description:
- 10 + years of product design experience in the medical device industry or equivalent.

- Expertise in the development of advanced materials technologies, preferably metals used for orthopedic medical implants and instrumentation.

- Expertise in the biological response to implant materials, including the host response to implant debris and corrosion by-products.

- Experience leading complex product development initiatives from concept through release.

- Expertise in design controls with in a regulated industry.

- Ability to apply expertise across multiple projects to ensure good design practices and standards are met.

- Demonstrated experience with experimental design and statistics.

- Demonstrated English composition writing skills.
Act as team expert in implant and instrument design work, championing as well the materials and biocompatibility perspective. Lead segments of complex multifunctional teams to advance assigned projects through the design /development process and ultimately through launch into the market. Act as team's technical expert with respect to good design practices and design standards. Champion the consistent use of these practices for the team.

Responsibility:


- Identify design / performance requirements for orthopedic implant / instrumentation systems. Review associated test protocols and final reports.

- Participate / Manage the Design Review process in order to facilitate the mentoring of less experienced engineers as well as reinforce best design practices.

- Develop and maintain best design practices for the development team.

- Conduct technical review of post-production risk analyses, including technical assessments, non-conformance reviews, post-market health risk assessments, and severity assessments.

- Set the direction and manage the work flow of other engineers within the scope of assigned projects.

- Develop prototypes for design verification and validation.

- Interface with clinical advisors to gether input for design and evaluation of new product.

- Utilize / Manage the Design Controls (NPDP) including the mentoring of others in the use of these tools.

- Participate on crossfunctional design teams to develop new product as well as address design issues / maintain existing ones.

- Expertise in all aspects of the surgical procedure in order to develop innovative solutions to solve / satisfy customer needs.

- Develop and manage project plans and time lines with in the scope of the NPDP guidelines

- Establish and maintain relationships with the key design consulting group in order to recognize and anticipate industry trends and user needs.

Education:

Bachelors degree in a science, with a Masters Degree in a technical discipline preferred.
Prefer Mechanical or Biomedical Engineering Qualifications/Work Experience: Percent Travel Required:<5%]]>Wed, 22 May 2013 02:59:00 GMThttp://www.stryker-careers.com/job/Mahwah-Chief-Engineer%2C-Biomaterials-Job-NJ-07430/2560769/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.stryker-careers.com/job/Mahwah-Chief-Engineer%2C-Biomaterials-Job-NJ-07430/2560769/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Requisition ID:24509BR Job Title:Legal Counsel Division:Corporate Business Unit:Legal Business Function:Legal Business Sub Function: Country:United States State:NJ City:Mahwah Shift:1st Job Description:Responsible for proactively handling a broad range of legal matters and driving compliance efforts associated with Stryker’s Trauma & Extremities Division.

- Serves as the “point person” for all legal issues related to Stryker’s Trauma and Extremitites Division by providing legal advice and counsel in a highly regulated environment governed by Stryker policies, U.S. Federal and State law and International laws.

- Drafts, reviews, negotiates and advises on various types of contracts including but not limited to Services, Distribution, Product Development, Consulting, Clinical Study, Non-Disclosure, Employment and other commercial agreements.

- Conducts legal analysis and provides counsel on laws, rules, regulations, and Stryker policies related to Stryker’s interactions with healthcare professionals, both in the US and outside the US, including but not limited to the US anti-kickback law, the FCPA and other local anti-corruption laws; and, further helps to ensure that Stryker’s compliance program in this area is robust and effective.

- Manages or assists in managing litigation and legal claims matters involving Stryker Trauma and Extremitites Division in collaboration with others on the Stryker Legal team and outside counsel.

- Reviews marketing, promotional and scientific activities and materials for compliance with Stryker policies and applicable laws.

- Drafts, implements, addresses and provides training designed to help educate and ensure compliance with applicable laws, rules and regulations.

- Partners closely with the Compliance Department on compliance initiatives, policies and programs and ensures Stryker’s Trauma and Extremitites Division is in compliance with applicable laws, rules, regulations and policies. Assists the compliance team in managing a robust compliance program to address key compliance risks.

- Partners closely with others in the Legal Department both in supporting countries outside the US and in supporting specialized functional areas in connection with matters associated with Stryker’s Trauma and Extremitites Division.

- Provides analysis and counsel on various other relevant legal issues as they arise or are assigned, including but not limited to, medical device regulations, intellectual property, employment, mergers and acquisitions, data privacy, competition law, anti-corruption / anti-bribery laws, liability avoidance, and sales and marketing related issues.


- Excellent organization skills; ability to manage multiple projects and conflicting demands

- Ability to work well independently and collaborate in a team

- Ability to build relationships with key clients, co-workers and business partners

- Possesses strong analytical and problem-solving skills

- Complies with all Stryker’s policies and procedures

- Demonstrated interpersonal, communication and presentation skills.

- Ability to communicate and to articulate/translate complex issues at all levels of the organization
Education


- University degree with strong academic record.

- J.D. / Law Degree with strong academic record.
Experience


- Minimum of 5 years experience in a law firm or corporate legal department.

- Significant experience dealing with complex legal issues with significant financial impact.

- Experience in compliance, commercial law and contracts.

- Must be well-organized, able to manage numerous projects and conflicting demands in a fast-paced environment.
Valued, but not required skills and experience


- Health care, life sciences, pharmaceutical, medical device, food or other highly regulated industry experience preferred.

- Previous experience in compliance, regulatory, litigation, intellectual property or employment law valued.

- International experience a plus. Qualifications/Work Experience: Percent Travel Required:20%]]>Tue, 21 May 2013 00:00:00 GMThttp://www.stryker-careers.com/job/Mahwah-Legal-Counsel-Job-NJ-07430/2608323/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.stryker-careers.com/job/Mahwah-Legal-Counsel-Job-NJ-07430/2608323/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Requisition ID:22457BR Job Title:Director, Health Policy & Reimbursement Division:Corporate Business Unit:Communications Business Function: Business Sub Function: Country:United States State:NJ City:Mahwah Shift:1st Job Description:Health Policy and Reimbursement Professional Needed! Join Stryker and become involved in working on a national and international level.

The Director of Health Policy and Reimbursement will:

Provide Partnership and Collaboration: Partner across decentralized and geographically dispersed organizational structures. Become a trusted colleague to divisional leadership teams by taking an active interest in their business in order to understand their needs. Build instant credibility in order to become the primary coordinator and contact point for health policy and reimbursement questions. Lead efforts with Product Development and Marketing organizations to develop reimbursement strategies and secure timely implementation to ensure reimbursement mechanisms exist at time of product launch.
Create Strategy: Analyze proposed payment regulations and policies by governments and private entities and provide detail on how these regulations will impact the business tactically and strategically. Identify emerging issues, political and economic trends. Develop key messaging for communication as well as recommend appropriate action plan to best represent the Company's interests among public and private sector audiences.
Inform and Guide: Develop understanding of complexities associated with the changing health care environment i.e., fee-for-service, shift to ACOs, federal/state health care reform risk, shift from payer to provider, Medicare and Medicaid Managed Care. Design and implement training programs and manage the activities of consulting groups. Ensure knowledge of reimbursement across treatment settings (i.e., hospital inpatient, outpatient, physician's office, home health, etc.).
Analyze and Interpret: Using your extensive Payer/Provider knowledge, interpret and analyze government trends as it relates to relevant legislation, public policy and Provider Payment & Coverage within the US healthcare system.

Education and Experience:

-Bachelor's degree, Masters Degree a plus,8-10 years of business experience in a marketing and/or clinical role, with a minimum of 10 years in healthcare reimbursement.
-Thorough understanding of CMS (Center for Medicare and Medicaid Services) regulations and payment policies as well as third party payor agreements.
-Medical Device or Biologics experience preferred.
-Proven experience in reimbursement with demonstrated knowledge of Medicare/Medicaid, and private payor reimbursement.

Skills

-Demonstrated ability to operate independently and handle multiple tasks with a high degree of motivation and initiative.
-Project management skills.
-Excellent verbal, written communication, presentation and advocacy skills.
-Interpersonal skills to interact with many levels of management.

Primary Duties and Responsibilities:

-Candidate will:
-Identify and develop reimbursement and outcomes strategies.
-Evaluate Medicare, Medicaid and private insurance coding, coverage and payment.
-Monitor, influence and manage Medicare policy and regulation.
-Provide billing and reimbursement support to sales reps and customers.
-Design and implement training programs and manage the activities of consulting groups.
-Liaison with Regulatory and Clinical Affairs to ensure appropriate clinical support and guidance when addressing reimbursement issues.
-Provide billing and reimbursement support to sales reps and customers under the guidance and oversight of our legal and outside consultant teams.
-Implement reimbursement training programs for sales, marketing and R&D personnel.

Ensure knowledge of reimbursement across treatment settings (i.e., hospital inpatient, outpatient, physician's office, home health, etc.).

Develop understanding of complexities associated with the changing health care environment i.e., fee-for-service, shift to ACOs, federal/state health care reform risk, shift from payor to provider, Medicare and Medicaid Managed Care.

Interpret and analyze latest CMS (Center for Medicare and Medical Services) information regarding Medicare and Medicaid issues as it relates to reimbursement, rebates and pricing policies within the US healthcare system.

Analyze proposed payment regulations and policies by governments and private entities and provide detail on how these regulations will impact the business tactically and strategically.

Work with Stryker International Affiliates to ensure consideration of reimbursement issues outside the United States are considered as appropriate, in product development plans and business plan rationale.

Nationwide travel to conventions, customer's meetings and industry associations meetings will be expected. (approx. 25% of time). Qualifications/Work Experience: Percent Travel Required:25%]]>Fri, 17 May 2013 02:59:00 GMThttp://www.stryker-careers.com/job/Portage-Director%2C-Health-Policy-&-Reimbursement-Job-MI-49002/2383728/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.stryker-careers.com/job/Portage-Director%2C-Health-Policy-&-Reimbursement-Job-MI-49002/2383728/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Requisition ID:23367BR Job Title:Clinical Research Associate Division:Neurovascular Business Unit:- Business Function:Clinical Affairs Business Sub Function:Clinical Research Country:United States State:CA City:Fremont Shift:1st Job Description:The Clinical Research Associate is at the forefront of managing studies that will lead to better patient outcomes in the Neurovascular space.

The Clinical Research Associate will be responsible for planning, preparing, executing and closing out in-patient Acute Ischemic Stroke Clinical Trials. The primary focus is AIS, however, this role may also support Hemorrhagic Clinical Trial activities.

Position Responsibilities may include:

- Track Screening & Enrollment and identify issues.

- Independently confirm that site regulatory documents match TMF

- Address non compliance issues at investigative site and develop CAPA if necessary.

- Reviews Project Plan, disseminates project information, assembles and tracks metrics data.

- Monitor Case Report Forms against medical records on a simple trial.

- Conduct device accountability at investigational site independently

- Train new study coordinators on ICH/GCP guidelines

- Identifies adverse events during monitoring and ensures sites complete appropriate reporting

- Assists in reviewing medical publications

- Assembles portions of clinical protocols in development under guidance of Sr. CRA and Project Manager

- Utilize clinical knowledge to improve clinical compliance on internal processes and at external clinical sites

Position Requirements

- 2+ years of direct related experience in Neurovascular, endovascular or Cardiovascular Clinical Trials.

- Bachelors Degree in Science or Healthcare Related Field Qualifications/Work Experience: Percent Travel Required:50%]]>Sun, 28 Apr 2013 03:00:00 GMThttp://www.stryker-careers.com/job/Fremont-Clinical-Research-Associate-Job-CA-94536/2458927/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.stryker-careers.com/job/Fremont-Clinical-Research-Associate-Job-CA-94536/2458927/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Requisition ID:23369BR Job Title:Sr. Clinical Research Associate Division:Neurovascular Business Unit:- Business Function:Clinical Affairs Business Sub Function:Clinical Research Country:United States State:CA City:Fremont Shift:1st Job Description:The Sr. Clinical Research Associate is at the forefront of managing studies that will lead to better patient outcomes in the Neurovascular space.

The Clinical Research Associate II will be responsible for planning, preparing, executing and closing out in-patient Acute Ischemic Stroke Clinical Trials. The primary focus is AIS, however, this role may also support Hemorrhagic Clinical Trial activities.

Position Responsibilities may include:

- Track Screening & Enrollment and identify issues.

- Independently confirm that site regulatory documents match TMF

- Address non compliance issues at investigative site and develop CAPA if necessary.

- Reviews Project Plan, disseminates project information, assembles and tracks metrics data.

- Monitor Case Report Forms against medical records on a simple trial.

- Conduct device accountability at investigational site independently

- Train new study coordinators on ICH/GCP guidelines

- Identifies adverse events during monitoring and ensures sites complete appropriate reporting

- Assists in reviewing medical publications

- Assembles portions of clinical protocols in development under guidance of Sr. CRA and Project Manager

- Utilize clinical knowledge to improve clinical compliance on internal processes and at external clinical sites

Position Requirements

- 8+ years of direct related experience in Neurovascular, Endovascular or Cardiovascular Clinical Trials.

- Minimum of 2 years field monitoring experience.

* Bachelors Degree in Science or Healthcare Related Field Qualifications/Work Experience: Percent Travel Required:50%]]>Tue, 14 May 2013 02:59:00 GMThttp://www.stryker-careers.com/job/Fremont-Sr_-Clinical-Research-Associate-Job-CA-94536/2547828/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.stryker-careers.com/job/Fremont-Sr_-Clinical-Research-Associate-Job-CA-94536/2547828/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Requisition ID:24364BR Job Title:Clinical Research Associate Division:Neurovascular Business Unit:- Business Function:Clinical Affairs Business Sub Function:Clinical Research Country:United States State:CA City:Fremont Shift:1st Job Description:The Clinical Research Associate is at the forefront of managing studies that will lead to better patient outcomes in the Neurovascular space.

The Clinical Research Associate will be responsible for planning, preparing, executing and closing out in-patient Acute Ischemic Stroke Clinical Trials. The primary focus is AIS, however, this role may also support Hemorrhagic Clinical Trial activities.

Position Responsibilities may include:

- Track Screening & Enrollment and identify issues.

- Independently confirm that site regulatory documents match TMF

- Address non compliance issues at investigative site and develop CAPA if necessary.

- Reviews Project Plan, disseminates project information, assembles and tracks metrics data.

- Monitor Case Report Forms against medical records on a simple trial.

- Conduct device accountability at investigational site independently

- Train new study coordinators on ICH/GCP guidelines

- Identifies adverse events during monitoring and ensures sites complete appropriate reporting

- Assists in reviewing medical publications

- Assembles portions of clinical protocols in development under guidance of Sr. CRA and Project Manager

- Utilize clinical knowledge to improve clinical compliance on internal processes and at external clinical sites

Position Requirements

- 2+ years of direct related experience in Neurovascular, endovascular or Cardiovascular Clinical Trials.

- Bachelors Degree in Science or Healthcare Related Field Qualifications/Work Experience: Percent Travel Required:50%]]>Tue, 21 May 2013 00:00:00 GMThttp://www.stryker-careers.com/job/Fremont-Clinical-Research-Associate-Job-CA-94536/2607751/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.stryker-careers.com/job/Fremont-Clinical-Research-Associate-Job-CA-94536/2607751/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Requisition ID:21856BR Job Title:Clinical Director Division:Neurovascular Business Unit:- Business Function:Clinical Affairs Business Sub Function:Clinical Research Country:United States State:CA City:Fremont Shift:1st Job Description:DESCRIPTION:
Provide strategic oversight of all Stryker Neurovascular Sponsored Research and Investigator Initiated Studies in compliance with relevant local, national, and international clinical trial regulations and guidelines and in accordance with divisional strategic needs. Position will be specifically responsible to facilitate the strategy, planning, development, and analysis of clinical studies including cross-regional coordination and implementation of worldwide clinical and product approval strategies.

- Works collaboratively to drive and develop global clinical trial strategies across multiple therapeutic franchise product lines.

- Ensures clinical trials are designed and executed in compliance with all global regulations and are consistent with global business objectives.

- Oversees the on-time, on-budget execution of clinical programs and advances all projects simultaneously.

- Participates in internal and external audits. Is expected to be the subject matter expert on clinical trial activities in concert with the clinical franchise program manager (therapeutic lead).

- Guides clinical program managers in the development of realistic clinical trial budgets, project schedules, and trial management. Allocates/re-allocates internal and external resources to projects, as needed.

- Directs research teams in accordance with project plans and performance standards.

- Coaches, mentors, and teaches others the appropriate application of laws and standards in the areas of clinical trial design, compliance, and ethical conduct of research trials.

- Conducts briefings and technical meetings as needed. Analyzes and presents data from external/internal sources and partners with other functions such as Regulatory Affairs to obtain regulatory product approvals and/or ensures program managers are adequately prepared to handle briefings and technical meetings.

- Interacts with and/or drives clinical trial discussions with regulatory agencies as needed and/or ensures program managers are prepared for such discussions.

- Provides direction for resolution of complex issues concerning the management of investigational site activities, safety, ethics, and physician relationships.

- Assumes responsibility for and execution of any other duties assigned by Manager to support division or function needs.

QUALIFICATIONS:

- Masters-level degree required preferably in a science/health related field (e.g., Biology, Nursing, Biomedical or Veterinary Sciences).

- Degree in business management preferred. Proficiency in resource planning and financial management (clinical trial budgeting) required.

- 10+ years clinical research experience (device, pharmaceutical, biotechnology), including at least 5 years in a managerial capacity managing projects and clinical professionals in a product development setting.

- International clinical research experience required; expatriate research work experience preferred.

- Previous trial design negotiation experience with FDA or other regulatory body required; IDE to PMA submission and approval experience preferred. Qualifications/Work Experience: Percent Travel Required:40%]]>Sun, 19 May 2013 02:59:00 GMThttp://www.stryker-careers.com/job/Fremont-Clinical-Director-Job-CA-94536/2295844/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.stryker-careers.com/job/Fremont-Clinical-Director-Job-CA-94536/2295844/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Requisition ID:22473BR-5359 Job Title:Senior Clinical Research Associate – Medical Devices Division:Asia Pacific Business Unit:South Pacific Business Function:Research & Development Country:Australia City:Sydney Job Description:Clinical Research is a key strategic initiative for Stryker in 2013 and this is your chance to get involved! We’re looking for a passionate, driven, high achieving Clinical Research professional to join our team and help us drive key strategic initiatives in Australia and New Zealand!

This is not your standard SCRA position! You will have the opportunity to get involved with all aspects of the Clinical Trial process including liaising with KOLs, consulting with surgeons to get new trials up and running, writing protocols, compiling ethics and governance submissions, monitoring, data management, study reporting and publication planning, as well as contributing to local and global strategies. You will also be liaising with internal departments including regulatory, marketing, legal and operations to ensure studies are not only well executed, but also well communicated. You will mainly be involved in phase IV medical device trials, within a specialised portfolio. The role involves approximately 30% travel.

The successful candidate will have a tangible passion for Clinical Research and 4+ years' experience within the clinical trial environment. You will stand out from the rest as a high achiever who isn’t ever satisfied with the status quo. You will love building relationships with sites, and will thrive in an autonomous environment where innovation is encouraged and welcomed. In your current role, you may be frustrated with your limited scope and be craving an opportunity to take true ownership of projects. If all of this excites you, apply below because we want to hear from you!

Stryker is one of the world's leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. We provide innovative orthopaedic and surgical implants, as well as state-of-the-art medical and surgical equipment, to help people lead more active and more satisfying lives.

Stryker is one of the largest players in the worldwide orthopaedic market and is at the forefront of medicine’s most promising solutions. At Stryker, we are more interested in who you are and what you can do, rather than what you have done. So to move forward for this or any other potential role within our business, please apply online. Qualifications/Work ExperienceSee Above EducationBachelor's degree preferred]]>Sat, 18 May 2013 05:31:00 GMThttp://www.stryker-careers.com/job/Sydney-Senior-Clinical-Research-Associate-Medical-Devices-Job/2362613/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.stryker-careers.com/job/Sydney-Senior-Clinical-Research-Associate-Medical-Devices-Job/2362613/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Requisition ID:24295BR Job Title:CQR Coordinator-(Allendale, NJ) Division:Spine Business Unit:- Business Function:Administrative and Support Services Business Sub Function:Secretary/Executive Assistant Country:United States State:NJ City:Allendale Shift:1st Job Description:Responsible for the planning, organization and clerical - administrative support necessary to the functions of the Clinical, Regulatory Affairs and Quality Assurance departments. Assists in responding to internal and external customer requests for routine departmental information.

Essential Duties & Responsibilities:

- Ensure that word processing, powerpoint and other clerical support is provided.

- Provide telephone support as needed.

- Provide timely departmental reports as assigned.

- Coordinate travel arrangements as needed.

- Schedule and arrange meetings as necessary.

- Order and maintain office supplies and equipment.

- Assist departmental personnel in providing documentation when required by other departments, divisions within the company or by external regulatory agencies.

- Process check requests, expense reports, and PO’s in a timely manner

- Maintain departmental files in an organized manner

- Assist with organizing meetings, AV equipment, scheduling conference rooms

- Organize special events such as department meetings

- Other duties as required

Qualifications/Work Experience Required:

- 3 - 5 years in an administrative support role

- Strong interpersonal, written, communication and organizational skills

- Strong computer skills including Microsoft Word, Excel, PowerPoint and Outlook

- Attention to detail

Education/Special Training Required:

- 2 year degree; 4 year degree preferred Qualifications/Work Experience: Percent Travel Required:0-5%]]>Sat, 11 May 2013 00:00:00 GMThttp://www.stryker-careers.com/job/Allendale-CQR-Coordinator-%28Allendale%2C-NJ%29-Job-NJ-07401/2593179/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.stryker-careers.com/job/Allendale-CQR-Coordinator-%28Allendale%2C-NJ%29-Job-NJ-07401/2593179/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Requisition ID:22473BR Job Title:Senior Clinical Research Associate – Medical Devices Division:Asia Pacific Business Unit:South Pacific Business Function:Research & Development Business Sub Function:Clinical Research Country:Australia State:- City:Sydney Shift: Job Description:Clinical Research is a key strategic initiative for Stryker in 2013 and this is your chance to get involved! We’re looking for a passionate, driven, high achieving Clinical Research professional to join our team and help us drive key strategic initiatives in Australia and New Zealand!

This is not your standard SCRA position! You will have the opportunity to get involved with all aspects of the Clinical Trial process including liaising with KOLs, consulting with surgeons to get new trials up and running, writing protocols, compiling ethics and governance submissions, monitoring, data management, study reporting and publication planning, as well as contributing to local and global strategies. You will also be liaising with internal departments including regulatory, marketing, legal and operations to ensure studies are not only well executed, but also well communicated. You will mainly be involved in phase IV medical device trials, within a specialised portfolio. The role involves approximately 30% travel.

The successful candidate will have a tangible passion for Clinical Research and 4+ years' experience within the clinical trial environment. You will stand out from the rest as a high achiever who isn’t ever satisfied with the status quo. You will love building relationships with sites, and will thrive in an autonomous environment where innovation is encouraged and welcomed. In your current role, you may be frustrated with your limited scope and be craving an opportunity to take true ownership of projects. If all of this excites you, apply below because we want to hear from you!

Stryker is one of the world's leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. We provide innovative orthopaedic and surgical implants, as well as state-of-the-art medical and surgical equipment, to help people lead more active and more satisfying lives.

Stryker is one of the largest players in the worldwide orthopaedic market and is at the forefront of medicine’s most promising solutions. At Stryker, we are more interested in who you are and what you can do, rather than what you have done. So to move forward for this or any other potential role within our business, please apply online. Qualifications/Work Experience:See Above Percent Travel Required:]]>Sat, 18 May 2013 05:31:00 GMThttp://www.stryker-careers.com/job/Sydney-Senior-Clinical-Research-Associate-Medical-Devices-Job/2362588/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.stryker-careers.com/job/Sydney-Senior-Clinical-Research-Associate-Medical-Devices-Job/2362588/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Requisition ID:22889BR Job Title:Endo - Associate Sales - S New Jersey Division:Endoscopy Business Unit:San Jose Business Function:Sales Business Sub Function:Field Sales Country:United States State:NJ City:S New Jersey Shift:1st Job Description:BASIC FUNCTION
Assists in Planning, directing, and coordinating the selling of Stryker Endoscopy products to physicians in accordance with budgeted objectives and to obtain maximum profitability and volume in relation to pre-set standards
RESPONSIBILITIES

- Assists in promoting and selling Stryker Endoscopy products.

- Educates and informs doctors, nurses, and appropriate staff personnel as to the proper use and maintenance of Stryker Products.

- Directs product evaluations in OR and office settings.

- May assist in the preparation and operation of trade shows, conventions, and/or clinical meetings.

- Keeps regional manager informed of territory progress on a regular basis.

- Solves product problems for customers in an expeditious fashion.

- May assist in the training and development of sales personnel. Qualifications/Work Experience: Percent Travel Required:50]]>Fri, 17 May 2013 02:59:00 GMThttp://www.stryker-careers.com/job/S-New-Jersey-Endo-Associate-Sales-S-New-Jersey-Job-NJ-07097/2433864/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSShttp://www.stryker-careers.com/job/S-New-Jersey-Endo-Associate-Sales-S-New-Jersey-Job-NJ-07097/2433864/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS