Join Our Team

Inside Sales Representative

About EMMA International

E.M.M.A. International Consulting Group, Inc. is a global leader in management consulting services, with headquarters in Farmington Hills, Michigan, as well as offices in Florida, Pennsylvania, and North Carolina. We focus on quality, regulatory, and compliance services for the Biotechnology, Pharmaceuticals, and Medical Device industries.

 

Summary

The Inside Sales Representative will be responsible for maximizing sales and profitability through relationship development with potential and/or current clients for our quality system and regulatory compliance services. With the aid of E.M.M.A. International operations and consulting personnel, the incumbent will establish and manage relationships with clients through initial outreach and follow up.

 

Essential Duties and Responsibilities

  • Develop new business leads to achieve sales goals.
  • Utilize prospecting and research tools to connect new leads and qualify opportunities.
  • Strategize with team members to innovate and improve the overall inside sales process.
  • Follow-up and place outgoing calls with various lead types received.
  • Accurately obtain and record client information into the E.M.M.A. International CRM system.
  • Reach and/or exceed daily and weekly lead generation goals.
  • Performs other related duties as required or assigned.

 

Knowledge, Skills and Abilities

  • Ability to follow systemized processes and scripts.
  • Effective time management skills to prioritize daily activities that result in greater lead generation results.
  • Must be a self-starter with a determined, goal driven and persistent personality.
  • Ability and desire to work as a motivated team player in a collaborative environment.
  • Excellent verbal communication skills and telephone manner.

 

Minimum Requirements

  • Associate’s degree in Marketing, Sales, Business Management.
  • 2+ years in sales, marketing and/or telemarketing experience.
  • Knowledge and experience working in the Life Sciences industry, a plus.

 

Physical Demands and Working Conditions

  • Ability to operate a computer and work at a desk for extended periods of time.
  • Minimal physical effort will be required in this position.

 

Location

Bingham Farms, Michigan (no relocation assistance available). Work days are Monday – Friday in an office environment.

Quality Engineer

Position Summary 

Responsible for the development, maintenance, and implementation of specifications and standards for processes, materials, and products in accordance with quality programs, plans, SOPs and policies of the company’s Quality System and in compliance with FDA regulations, ISO 13485, and other regulatory requirements as applicable.

 

Qualifications

BS or MS degree in technical/scientific/engineering discipline, with at least 2+ years of experience in medical devices, in vitro diagnostics or a related industry. Experience developing and implementing quality plans and programs. ASQ certification (CQE, CRE) is preferred. Working knowledge and experience of FDA’s Quality System requirements (QSR), ISO 9001 and ISO 13485 standards. Ability to coordinate multiple project schedules and activities.

The candidate should have strong analytical, communication and interpersonal skills. Strong linguistic, grammar, and editing skills. Ability to multi-task in an environment with changing priorities. Strong statistical training, skills and experience.

Proficiency with Microsoft applications Word, Excel, Project, Visio, and PowerPoint. And ability to learn additional software applications, as the need arises.

 

Principal Duties and Responsibilities

  • Assist in the development, implementation, and maintenance of Quality System specifications and requirements in accordance with cGMPs, ISO 13485 and other International regulations as applicable.
  • Direct and/or participate in projects directed at the development and implementation of quality standards throughout the company.
  • Participate in department meetings to provide input into the design and implementation of product specifications.
  • Write, review and edit documents and SOPs as required.
  • Assist during FDA inspections, ISO Certification and surveillance audits and customer and supplier audits.
  • Assist in validation activities and development of requirements and specifications.
  • Follow-up on corrective action responses, ensuring implementation of appropriate problem resolution methods and verifying effectiveness.
  • Facilitates problem-solving activities, team building and quality systems tools and methodologies.
  • Collaborate with other departments and functions on continuous improvement opportunities of the Quality System.
  • Carry out other duties as required or assigned

Medical Writer

Position Summary

The Medical Writer collaborates with members of cross-functional teams to prepare high-quality protocols, investigator brochures, synopses, regulatory documents, clinical publications, and related clinical documents within agreed-upon timelines.

 

Essential Duties 

To perform this job successfully, an individual must be able to perform the following:

  • Prepares, edits, and finalizes protocols, investigator brochures, synopses, regulatory documents and related clinical documents, such as abstracts, posters, presentations, and manuscripts
  • Participates in scientific communication planning, including development of strategic medical communication plans
  • Partners with the study biostatistician to engage early with the study team including participation in the review of mock and/or blinded tables, figures, and listings (TFLs), and narrative planning for relevant documents
  • Works closely with the study team to ensure that results and messages in clinical documents accurately reflect the data in TFLs and other information sources.
  • Schedules and conducts document-related meetings including the preparation of pre-meeting agenda, key data points for discussion, and post-meeting minutes
  • Collaborates with clinicians, clinical scientists, biostatisticians, and pharmacokineticists to interpret study results and ensure study results and statistical interpretations are accurately and clearly reflected in relevant documents
  • Manages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed
  • Works closely with the study team to reach consensus on timelines for deliverables
  • Completes documents according to agreed-upon timelines and follows up with the study team as needed to meet internal and external timeline commitments, and to ensure SOP and regulatory compliance
  • Understands the functions and roles within the study team and aligns with them in delivery of documents to meet project-related goals and to meet external results disclosure obligations
  • Ensures that medical writing deliverables conform to International Conference on Harmonization (ICH) and other relevant regulatory guidelines
  • Creates and maintains standard operating procedures and work instructions for preparation and maintenance of compliant medical writing deliverables
  • Ensures documents are generated in accordance with agreed internal processes and standards, are submission ready, and are appropriately stored in agreed document management system
  • Ensures that appropriate documented quality control (QC) checks are performed on medical writing deliverables, responds to findings, and recommends quality process improvements
  • Suggests or identifies changes, modifications, and improvements to the document preparation processes and templates in order to improve quality, efficiency, and productivity
  • Align with department management to set strategy for meeting department goals

 

Qualifications

  • This is not an exhaustive list of qualifications

 

Education

  • A minimum of a Bachelor degree in medical-related field or life science.
  • Bachelor’s degree +4 years of experience, or Master’s degree and relevant medical writing experience in the pharmaceutical industry, nice to have experience is writing in one or more of the oncology diagnostic or gynaecological therapeutic areas
  • An understanding of the drug development process
  • Broad experience managing the medical writing responsibilities associated with multiple studies at various stages
  • Experience in interacting with cross functional study team members
  • Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research and medical writing standards; demonstrated ability to interpret and apply these guidelines to document writing
  • Ability to work independently with minimal supervision, multi-task, and work effectively under pressure; adapt to change as needed; possess excellent project management skills; attentive to details
  • Ability to communicate with teams to set realistic timeline expectations; demonstrated ability to deliver within agreed internal and regulatory timelines; monitor and communicate progress against milestones; escalate complex issues appropriately.
  • Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members

 

Working Conditions

  • The work will be performed in an office environment.
  • Minimal physical effort will be required in this position.
  • Work days: Monday – Friday, 8:00 a.m. – 5:00 p.m.

 

The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor.

Software Quality Engineer

About EMMA International

E.M.M.A. International Consulting Group, Inc. is a global leader in management consulting services, with headquarters in Farmington Hills, MI, as well as offices in FL & PA. We focus on quality, regulatory, and compliance services for the Biotechnology, Pharmaceuticals, and Medical Device industries.

 

Summary

The Software Quality Engineer will be responsible for effectively managing all aspects of QualiPro, an Enterprise Quality Management Software (EQMS) offered exclusively by EMMA International through our partnership with Saphir Consult. QualiPro is an end-to-end quality management software suite that will ensure that your business follows U.S. and international standards, regardless of the industry. QualiPro helps facilitate the implementation of integrated quality management processes by providing you with a world class EQMS that is cost effective, interactive, and user-friendly. For more information, visit www.emmainternational.com.

 

Essential Duties and Responsibilities

  • Provide product demos.
  • Effectively educate and engage customers to solutions leveraging QualiPro’s benefits leading to competitive conversions.
  • Ensure regulatory compliance for all IT-related activities including new implementations, validations and documentation review.
  • Work with internal & external teams on configuration management and customization of the software to reflect the customer requirements
  • Work with the software developer and the internal technical team on all related software upgrades
  • Serve as a liaison for all QualiPro related issues
  • Triage issues, problem solve and follow up accordingly to ensure customer satisfaction.

 

Knowledge, Skills and Abilities

  • In-depth knowledge of enterprise quality management software tools
  • In-depth expertise in cGMPs, 21 CFR part 11, 21 CFR Part 820, and ISO standards
  • Ability to communicate effectively in writing, in person, over the telephone and in e-mail
  • Ability to quickly learn technical skills
  • A proven track record in understanding the process of specifying, identifying and implementing EQMS applications will be as essential
  • Having the know-how in software development and testing methodologies
  • Familiarity with global regulations and guidance documentsExperience with gathering requirements, performing business analyses and managing user relationships
  • Strong understanding of Life Sciences, Medical Device and Manufacturing industries
  • Customer Service experience and training
  • Strong understanding of manufacturing regulations preferred
  • Goal-oriented focus, excellent time management skills and great work ethic
  • Must be a motivated team player and flexible with regards to duties and working hours
  • Willingness to travel

 

Minimum Requirements

  • BA/BS required
  • 10+ years of experience in quality system management, compliance, validation or another quality role within the medical device or pharmaceutical industry
  • Strong leadership and presentation skills
  • Strong understanding of MS Office applications

 

Physical Demands and Working Conditions

  • Ability to work non-standard hours
  • Extensive travel required
  • Ability to operate a computer and work at a desk for extended periods of time

If you’re interested in a career in quality and compliance, please send a Cover letter and Resume to: careers@emmainternational.com.

Want to be a consultant?

Our team includes more than full-time staff members. We’d love to have you on our team of expert compliance consultants who help our clients navigate the complex work of compliance. Our consultants work in medical devices, pharmaceuticals, biologics, and more.

 

Please fill out our consultant questionnaire so we can learn more about you.