Position: Technical Editor II
Location: Wilmington, DE; Remote
Company Overview: Regulatory and Communications Strategy, Science, and Solutions
As the largest consultancy of regulatory and medical writers in the industry, Synchrogenix is already a well-recognized, multi-disciplined provider of regulatory writing, operations, and communications services. Additionally, our innovative technology platform, which includes both the ClinGenuity™ Artificial Intelligence (A.I.) engine and the GlobalSubmit™ portfolio of electronic common technical document (eCTD) and regulatory information management (RIM) software, brings a unique end-to-end solution to our clients with the capability to transform the way we plan, create, deliver, and access and track information – all of which is essential to empowering decision-making for various stakeholders who are invested in healthcare research and innovation.
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 expertise—has something to teach and something to learn.
Providing regulatory and communications strategy, science, and solutions to life science companies worldwide. Our regulatory expertise and innovative technology bridges the full regulatory continuum to propel treatments to the market by meeting the needs of all stakeholders and improving public health outcomes.
To revolutionize global healthcare by delivering transformative and innovative approaches to regulatory and communications strategy, science, and solutions. To build next generation talent, solutions and technology that remove barriers and create efficient pathways to treatment and information. We provide expertise in:
- Regulatory Intelligence, Policy & Strategy
- Synchrogenix’s Office of Regulatory Intelligence, Policy and Strategy is comprised of proactive policy drivers focused on efficient planning who provide real-time regulatory insights to guide sponsors through the global regulatory maze by making connections with new precedents and trends to influence outcomes and maximize success.
- Regulatory Communications
- Quality information handling is vital throughout a drug’s lifecycle. Synchrogenix provides distinct market offerings that advance and protect ownership, yet support collaboration through customer engagement and transparency.
- Regulatory Operations
- Synchrogenix ensures efficient, timely submissions through software and services solutions that break down barriers between strategy, dossier development and global transmissions. Through experience, expertise, and industry insight, Synchrogenix quickly responds to changes in global regulatory requirements and mandates, thus avoiding common issues that can lead to rejections.
- Global Stakeholder Communications
- Synchrogenix provides expertise and relevant communications to global audiences through services and innovative technology. Our offerings support our clients’ regulatory compliance, while reducing risk and enhancing potential for market success. These offerings include, but are not limited to: regulatory writing, medical communications, safety/pharmacovigilance, patient engagement, and transparency and disclosure.
- Technology & Innovation
- Synchrogenix delivers interoperable and innovative technologies that support our services and differentiate ourselves in the market. Additionally, Synchrogenix provides strategy and delivery capabilities to implement emerging technology solutions both internally and externally.
- As appropriate, suggests revisions with an understanding of the format, content, and quality
- expectations typical for standard study-level documents.
- Operates independently with minimal direction from project lead. Looks for solutions and
- communicates proactively if issues occur.
- Serves as a formatting, style, grammar, publishing, or client-specialist resource to others.
- Demonstrates ability to mentor less experienced colleagues and consistently serves as a “go-to”
- person for a certain type of project.
- Performs assignments by utilizing the appropriate QC checklist ensuring that appropriate
- documentation is complete for all assignments.
- Interacts directly and communicates clearly with internal and external customers and/or project
- managers regarding all assignments.
- Consistently adheres to Synchrogenix standards, policies, and procedures as defined in the
- Employee Manual and Standard Operating Procedures.
- Maintains confidentiality with respect to client information and Synchrogenix materials.
- Maintains client document timelines and deliverable matrix
- Manages budget for respective task within a project
Among other duties, the Technical Editor II must be comfortable with formatting in Word, including:
- Creation, modification, and implementation of styles
- Creation and modification of tables and table borders
- Insertion and modification of figures
- Modification of page margins
- Insertion and modification of a Table of Contents, List of Tables, and List of Figures
- Insertion and modification of headers and footers
- Insertion of captions and cross-references
- The Technical Editor II will also be capable of performing quality control review, including:
- Verification of document against source
- Verification of internal consistency
- Verification of grammar based on understanding of grammar rules
- Bachelor’s degree in English, Journalism, Scientific discipline or related field
- ELS certification desired, but not required
- 2-4 years of prior related experience; highly skilled, talented, and motivated candidates will be
- Strong computer skills, including proficiency with Microsoft Outlook, Word, Excel, and
- Background in pharmaceuticals and/or science and technical industries is preferred
- Demonstrates solid time management skills.
- Shows flexibility to meet project needs as required by deadlines and meeting corporate goals
- and objectives.
- Maintains high ethical and quality standards as defined in the Employee Manual
- Ability to synthesize data and present it in a written format
- Shown success in Word skills and document management techniques
- Understanding of document creation process
- Experience document editing, formatting, and quality control (QC)
- Understanding of GXP, ICH E3, eCTD, and AMA style guidance and version control, Word
- Organized, efficient, flexible, self-motivated
- Good communication skills and the ability to work well with others are essential
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.
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