Position: Business Analyst
Synchrogenix, a Certara® company, is a global, multimillion-dollar regulatory and scientific writing company headquartered in Wilmington, DE, with US offices in Atlanta, GA; Thousand Oaks, CA; Cincinnati, OH; Philadelphia, PA; Raleigh, NC; Malvern, PA; Parsippany, NJ; San Diego, CA; Nashville, TN; Orlando, FL; Gaithersburg, MD; and Cambridge, MA. Synchrogenix has two wholly owned subsidiaries: Synchrogenix Europe Limited, headquartered in Daresbury, UK, with an additional office in London; and Synchrogenix Philippines Inc. (SPI), headquartered in Manila.
Founded in 1986, Synchrogenix takes a unique team approach to projects drawing from the varied skills and backgrounds of its writers and editors. This approach enables Synchrogenix to bridge all functional areas within drug development, with the singular focus on regulatory/medical documentation. Regulatory writing is truly an expertise, and Synchrogenix’s 170+ permanent writers and editors are among the best in the world.
Synchrogenix now offers additional technologies and services that expedite the regulatory process.
The only artificial intelligence assisted medical writing service in the pharmaceutical industry. This transformative technology helps clients to better meet global transparency and disclosure requirements.
Submission Management - our suite of products consists of the solutions regulatory operations professionals need to efficiently manage and publish, validate and review eCTD submissions.
Regulatory Services - submission and publishing services for marketing and pre-marketing applications as well as subsequent lifecycle submissions to support original applications.
Document Management - an intuitive, affordable document management system that reduces complexity form a user perspective while meeting the same robust standards for security and regulatory compliance
This combined knowledge makes Synchrogenix the consultancy of choice for life science and biotechnology companies worldwide.
Synchrogenix was named one of the INC 500/5000 Fastest Growing US Companies in 2012, 2013, 2014, 2016 and 2017 and has been named a Best Place to Work multiple times.
Synchrogenix was founded on the principles of ethical business practices and high-quality work. It is a learning-oriented organization with a strong commitment to the idea that every individual—regardless of experience level—has something to teach and something to learn.
Synchrogenix has built its culture on:
Being fast and flexible, non-hierarchical, apolitical, and non-defensive
Active participation—nobody sits on the sidelines
Teamwork—the company’s success is important to all of us
Cross-functional communication (lots of it) and a high-tech culture that works to have everyone on the same page
Disciplined leadership that inspires passion and commitment
Strong peer and management support for those who want to learn
The Business Analyst reviews, analyzes, and evaluates user needs to create systems solutions that support overall business strategies. Documents system requirements, defines scope and objectives, and creates system specifications that drive system development and implementation. Incumbents function as a liaison between IT and users and have both business and technical expertise. They will collaborate in the creation of high quality software requirements and user designs. Our team’s goal is to deliver the best integrated solutions to our clients. As a member of the Product Management team, this individual is expected to work on multiple projects simultaneously providing requirement expertise in accordance with company Standard Operating Procedures. The Business Analyst will play an integral role in shaping new products and be an expert in our clients’ experience.
Perform product research to assist with identifying business needs
Evaluate data collected through stakeholder interaction, task analysis, business processes, business intelligence, analytics, surveys and workshops to enable data-informed decisions
Align with product manager to understand business goals, product roadmap, and epic priorities
Propose technology solutions to achieve product and business goals
Review technical solutions to ensure the business requirements and long-term product goals are being met
Prepare accurate and detailed functional/non-functional requirement specifications
Document business requirements and translate them into detailed user stories and acceptance criteria for the delivery team
Triage user feedback to classify in alignment with defined procedures
Work in close collaboration with product management, user experience and engineering teams throughout the product lifecycle
Build relationships and work with cross-functional teams to drive products from inception to launch
Bachelor’s degree or equivalent experience
Good verbal and written communications skills
Travel will be at a minimum
At least 3 years of experience in software development or product management domains
Proven experience of testing complex user interfaces
Experience working with FDA regulated submissions
Experience working with pharmaceutical research
Experience with cloud-based software solutions
The Ideal Candidate
Is reliable, professional and discrete, and personable with business acumen
Is a team player who is flexible with an extremely high level of attention to detail and enjoys collaboration
Is deadline conscious with strong leadership and management of process
Is self-motivated and solution-driven
Can manage changing and competing priorities in a fast-paced environment
Desires challenges, both technical and interpersonal
Opportunity and Value for the Right Candidate
Make an immediate contribution
Be a critical driver to overall company success
Variety — submission-level work across therapeutic areas
Flexibility — custom schedules and benefits of “flex time”
Stability — almost 32 years in business
Support — a community of writers working as a team
Grow – excellent potential for growth and advancement
Learn – gain valuable knowledge and expertise for development and advancement (training provided); the ever-evolving pharmaceutical and biotech industries, and a niche segment, that is growing exponentially.
Competitive compensation and benefits package
Synchrogenix is proud to be an Equal Opportunity Employer and will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status, or any other characteristic protected by law. Synchrogenix makes reasonable accommodations for disabled employees and applicants. Synchrogenix only employs individuals with the right to work in the country/ies where the role is advertised. We are committed to fostering, cultivating, and preserving a culture of diversity and inclusion. The collective sum of the individual differences, life experiences, knowledge, inventiveness, innovation, self-expression, unique capabilities and talent that our employees invest in their work represents a significant part of not only our culture, but our reputation and achievement.