Job Opening For: Regulatory Affairs Analyst / Compliance Specialist
Location: [Remote]
Department: Application/Product Development
Reports To: Executive Director
Job Summary:
The Regulatory Affairs Analyst will support MEDLEX SYNERGY's healthcare and pharmaceutical clients by ensuring that digital and web-based deliverables (including websites, regulatory submissions, marketing content, and software solutions) comply with relevant FDA, EMA, and other industry-specific regulations. The Analyst will also act as a subject matter expert on product documentation and technical compliance across digital marketing initiatives serving clients in the health, biotech, and pharmaceutical sectors.
Position Overview:
The primary responsibility of this role is to ensure that the web platforms, content strategies, and digital tools we deliver to our pharmaceutical clients adhere to relevant U.S. and international regulatory frameworks.
Job Duties:
- Analyze and interpret FDA, EMA, and other international regulations applicable to digital content and product promotion in the pharmaceutical and medical device sectors.
- Collaborate with the software development and marketing teams to ensure that content and web platforms for medical and pharma clients meet regulatory and technical documentation standards.
- Review technical documents, labels, safety information, and compliance disclaimers published on digital platforms.
- Assist in preparing regulatory submissions or documentation for clients, including compliance matrices and audit trail logs.
- Conduct internal audits and gap assessments for client websites or digital applications to ensure regulatory alignment.
- Monitor changes in U.S. and international regulatory agencies, and help integrate updates into client-facing content or service platforms.
- Provide domain-specific consulting to developers and content strategists, advising on chemical product classifications, drug labeling rules, and technical specifications.
- Prepare Standard Operating Procedures (SOPs) and training materials related to compliance workflows.
Qualifications:
- A background in chemical engineering, pharmaceutical sciences or a related field is essential to understand drug composition, safety protocols, regulatory frameworks, and scientific terminology relevant to pharma products.
- The role requires technical comprehension of chemical product categories, drug product development, labeling, and medical device/software regulations — areas in which general digital marketers or compliance professionals without a scientific degree would be unqualified.
- Regulatory interpretation, documentation authoring and review, and risk evaluation, which are specialized tasks aligned with professional training in the chemical or pharmaceutical field is required.
Soft Skills & Fit:
- Strategic thinker who’s also willing to “roll up sleeves.”
- Entrepreneurial mindset with a bias for execution.
- Excellent communication skills.
- Adaptable, resourceful, and team-oriented.
Engagement & Compensation:
- Flexible engagement: Full-Time
- Compensation commensurate with experience, range $38000 - 40000per year.
Job Opening For: PROJECT MANAGER
At MedLex Synergy, our services are focused at enabling the Federal Agencies to meet their modernization and transformation requirements. Our creative focus is on offering full range of planning, implementation and operations of Cloud based systems. Our project teams work with federal agencies and try to quickly solve their mission- critical problems by identifying, designing, and implementing technology enabled solutions which in turn improve their strategies and operations. You must possess superb communication, analytical and time management skills.
In Addition, you should also have:
- Ability and desire to continually learn new technologies in a changing environment
- Analytical and problem solving way of thought
- Overall resilient, flexible, and enthusiastic personality
JOB DESCRIPTION:
ADW is currently seeking to hire a Project Manager to support our projects in Washington, DC. The Project Manager will be responsible for leadership, delivery, and oversight of ADW's engagements serving U.S. Federal government clients. In addition, you will be responsible for developing and managing relationships with clients to ensure close collaboration on existing engagements and to develop future business opportunities. The ideal candidate will be a strong leader who combines an entrepreneurial mindset and practical 'get it done' work style with deep subject matter expertise in IT solution delivery including business requirements, software design, development, and implementation, program and project management, and quality assurance. Exposure to large scale federal programs and initiatives and services, managed services, or information technology operations is fundamental to this position. Applicant must be a U.S. citizen or permanent resident.
ROLES AND RESPONSIBILITIES:
- Serve as the single point of leadership for Program and own end-to-end accountability for program delivery by driving engagements/programs to successful completion
- Engaging with client leadership to ensure proper expectation setting
- Build consensus and decision-making with business, partners, IT and executive management
- Ensures our methodology and enforces project standards and monitors deliverables prepared by team before passing to client
- Partnering with stakeholders (internal and external to Creative) to ensure proper strategy, plan, alignment, integration and visibility
- Manages day-to-day operational aspects of a project and scope with project teams and ensuring sufficient face-time with key executive stakeholders
- Provides status reporting to internal and external stakeholders on a regular basis
- Anticipates and identifies potential problems or risks related with the project and offers alternative solutions to problems.
- Leading, coaching, managing and mentoring project managers
REQUIREMENTS:
- 5 + years of project management experience
- Proven track record of leading enterprise scale, complex technology programs successfully
- Previous people leadership and management skills, including direct experience leading, managing and mentoring teams of project managers
- Successful track record of delivering projects on scope, on time, on budget, on quality and on benefit
- Demonstrated ability to manage the details of programs / projects in order to drive them to fruition
- Excellent communication, collaboration, team building and relationship management skills
- Ability to communicate technology matters to business partners, senior executives, and strategic partners
- Proven experience interfacing in large organizations/agencies
- Capable of gaining support for initiatives through influence and use of business rationale
- Proven ability to make and implement tough decisions
- Prior experience serving as a consultant to government clients
- Strong knowledge of software quality assurance best practices and methodologies
- Knowledge of Business Process Management (BPM) techniques and tools
- Certifications - PMP certification is a must
EDUCATION: Applicant requires a bachelor's degree and 3-5 years managing IT projects (experience in software as a service projects a plus)
Job Opening For: ASP.NET SQL SERVER DEVELOPER
We are looking for .Net Developer with our direct client. If interested, please apply with your word format resume and availability. We need to close this position ASAP, appreciate your immediate response.
Position: .Net Developer
Duration: Fulltime / Direct hire
Work Status: H1, USC or GC or EAD
Excellent Communication skill is required.
Job Description:
- Solid hands on coding skills in C#, .Net and WCF
- Strong debugging, analytical and problem solving skills
- Familiarity with OOD concepts and design patterns
- Experience with enterprise software development
- Proven track record of shipping major projects
- Ability to work in cross functional teams with strong interpersonal skills
- Prior experience with ASP.NET, SQL Server, C#.Net, TFS, XML, JQuery and service oriented architecture is desirable
- Knowledge about Monitoring, Tracking and Tracing is a plus
- Experience with Logging, Tracing and Performance-Counters is desirable
Mandatory/ Primary Skills
ASP.NET, C#, .Net, WCF, SQL, TFS
Job Opening For: DATABASE DEVELOPER/PROGRAMMER
MedLex Synergy offers an immediate opportunity for Database Programmers to join our rapidly growing firm. We are looking for excited, energetic, competent and experienced professionals who are looking to join a detail-oriented organization with focus on growth and success.
Job Description & Essential Responsibilities:
- Review project specifications and participate in discussion with Project Managers and/or management.
- Produce accurate deliverables based on project scope provided by case team.
- Deliver a quality product on time and on budget.
- Available to work on flexible schedules and in overtime when necessary to ensure deadlines are met.
- Additional duties as assigned.
Qualifications:
- Strong knowledge of relational databases and possess programming, development and data manipulation, experience using VB/VBA, MS SQL, and Access.
- Associates or a Bachelor’s degree in Technology fields, preferred.
- 5+ years experience in relational database management systems, including Access and SQL server.
- General working knowledge of Adobe and MS Office Suites (Word, Excel, Access).
- Knowledge of VB scripting or VBA.
- Ability to communicate effectively and tactfully (verbal and written) to technical and not-technical colleagues, including senior management.
- A strong desire to learn new skills.
- Ability to work effectively under pressure.
Job Opening For: CORE JAVA DEVELOPER
At MedLex Synergy, we are expanding our Consulting Team in the DC Area. If you have core java development skills and interested in learning Search, we could be the right place for you!
Duties are as follows:
The Engineer will undertake activities on a project-by-project basis, either individually or as part of a larger team, and in projects that will vary in duration. She/he develops and customizes application based on the business requirement for specific client projects in a variety of markets. She/he provides onsite analysis and written assessments of existing customer installations with recommendations for improvements or upgrades. She/he participates in the analysis and design of both internet and intranet-based search applications.
Essential Job Functions:
Designs/codes applications following specifications using tools that will vary depending on the project, including but not limited to:
- Programming Languages: Java, C# (.NET), Python, Perl, Groovy, JavaScript
- Enterprise search platforms
- Frameworks: Maven, Ant, Spring, Struts, Hibernate, WebAPI, AngularJS, BootStrap
- Technologies: XML, XSLT, CSS/XHTML, SOAP
- Security Protocols/Standards: Kerberos, LDAP
Essential Competencies:
- Full software development lifecycle experience
- Knowledgeable of current software engineering practices
- Knowledge of a minimum of one enterprise search platform (Solr, Lucene, Google, Microsoft Fast, Endeca)
- Excellent client-facing skills
- Problem solving/analysis
- Strong oral and written communication skills
- Time management skills
- Ongoing ability and desire to learn new technologies
- Ability to work independently or as part of a team
Required Education and Experience:
- College degree in Computer Science, Engineering, or similar
- Minimum five years of experience in software development environment(s)
Preferred Education & Experience:
- Experience leading small engineering teams (2-4 members)
- Basic system architecting experience
Additional Eligibility Qualifications:
- Oracle Java Certified Associate and or Java Certified Professional
Job Opening For: QUALITY ASSURANCE ANALYST / SOFTWARE TESTER
At MedLex Synergy, we are currently having an excellent opportunity for a candidate having interest in development and who is dynamic, intelligent, and independently motivated! The primary focus of the QA Analyst is to ensure the functionality of Point-Of-Sale (POS) program. You will be responsible for developing Automated Test Programs in an advanced quality assurance lab for demanding applications.
Position requirements include:
- Minimum of 1 year related experience
- Hands-on experience and knowledge of VISUAL BASIC, .NET & Windows Operating Systems.
- Prior experience w/Automated Testing of software programs in a Windows environment
- Knowledge of Rational Test and previous RESTAURANT experience a plus
- A general programming logic test will be administered during the interview process to demonstrate capability
- Candidate must be able to work onsite; NO TELECOMMUTING
Work Status: H1, USC or GC or EAD
Please send following information along with updated resume in MS Word format:
- Full Name:
- Expected Salary:
- Mobile:
- Home:
- Email ID:
- Skype ID:
- Work Authorization:
- Availability:
- Present Location:
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