Syneos Health Life Sciences Medical Editor Job Opening – Apply Online
Syneos Health Life Sciences Medical Editor Job Opening – Apply Online. Syneos Health Sr Medical Editor (Safety Documents-ICFs,CSR) vacancy is available. Interested and eligible applicants can check out all of the details on the same below
Possible Interview Questions for Sr Medical Editor (Safety Documents-ICFs,CSR)
are posted below
Sr Medical Editor (Safety Documents-ICFs,CSR)
Updated: July 06, 2023
Location: India-Asia Pacific – IND-Gurugram-DLF Downtown
Job ID: 23003973
Senior Medical Editor
Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help
our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
Why Syneos Health
- We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
- We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
- We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.
Job Responsibilities:
- Maintains familiarity with FDA, EU, and other relevant guidelines and industry standards to ensure that documents meet or exceed sponsor and regulatory requirements and guidance.
- Represents the editorial group in Medical Writing, on study teams, and in cross-departmental project teams as needed.
- Monitors timelines and budgets for assigned projects and updates the Lead Medical Writer, Project Manager, and/or direct supervisor (as appropriate) if deliverables are at risk.
- Provides technical support and expertise as appropriate. Conducts training of medical editing staff and functions as a mentor. Advises medical writers, medical editors, and study teams on data integrity review, compilation, publishing, and editorial standards. Provides training to members of the global Medical Writing team in aspects relative to their roles.
- Project lead for deliverables of assigned complex and/or large medical writing projects, including but not limited to scheduling and leading internal project-specific team meetings, organizing project-specific requirements, and ensuring that all information is distributed to the editorial team and implemented within the deliverable.
- Serves as a member of the medical writing team for projects with medical writing deliverables. Provides feedback to the lead medical writer on progress of document editorial process.
- Copyedits assigned documents, applying correct grammar, punctuation, spelling, and style following American Medical Association (AMA) or various custom style guidelines as well as established medical writing internal checklists and best practices.
- Performs data integrity review of assigned documents to ensure accuracy.
- Contributes to the development of process improvement tools and the development or revision of internal policies and procedures affecting editorial work.
- Manages assigned projects according to medical writing standard operating procedures and client standards, on time and on budget.
- May compile and publish medical writing deliverables.
Qualifications
What we’re looking for
- Bachelor’s degree (preferred) in the life sciences, clinical sciences, or English/journalism; or copyediting, data integrity review, and/or relevant publishing experience.
- Significant relevant publishing experience using Adobe Acrobat or other appropriate markup language preferred; ISIToolbox experience preferred.
- Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint).
- Excellent attention to detail, including strong copyediting, data integrity review, accuracy, problem solving, organizational, interpersonal, presentation, project management, and team-oriented skills.
- Excellent grammatical and communication skills, both written and oral.
- Extensive familiarity with the AMA style guide strongly preferred.
- Ability to work with minimal supervision on multiple assignments with set deadlines.
- Ability to work independently as well as part of a team and keep others informed of the progress and status of projects.
- Adaptable to changes in work duties, responsibilities, and requirements.
- Knowledge of FDA and EU requirements, ICH regulations and ISO standards as applicable to regulatory documents preferred.
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health
Additional Information:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Possible Interview Questions for Sr Medical Editor (Safety Documents-ICFs,CSR):
- Can you describe your experience in ensuring documents meet regulatory requirements and guidelines, such as FDA and EU standards? Provide an example of a project where you successfully ensured compliance with these guidelines. Answer: In my previous role as a Senior Medical Editor, I maintained familiarity with FDA, EU, and other relevant guidelines to ensure documents met sponsor and regulatory requirements. For instance, in a recent project, I carefully reviewed and edited clinical trial safety documents, including Investigator’s Brochures and Clinical Study Reports, to ensure they adhered to FDA and EU guidelines. By closely following these standards, we successfully met regulatory requirements and provided accurate and compliant documents.
- How do you manage timelines and budgets for assigned projects? Share an example of a project where you effectively monitored timelines and addressed potential risks to deliver high-quality work within the allocated resources. Answer: As a Senior Medical Editor, I prioritize project timelines and monitor budgets to ensure smooth project execution. In one project, we encountered unexpected delays in data collection, which posed a risk to our deliverables. To address this, I promptly communicated the situation to the Lead Medical Writer and Project Manager, enabling us to adjust the project plan and allocate resources efficiently. By closely tracking progress and proactively addressing risks, we successfully delivered the required documents within the given timeline and budget.
- How do you ensure data integrity and accuracy during the editing process? Explain your approach to conducting data integrity reviews and maintaining document accuracy. Answer: Data integrity is crucial in medical editing. In my role, I conduct thorough data integrity reviews of assigned documents to ensure accuracy and consistency. I carefully verify and cross-reference data points, statistics, and references, and collaborate with medical writers and study teams to address any inconsistencies or discrepancies. By following established internal checklists, adhering to industry standards, and maintaining a keen eye for detail, I ensure the integrity and accuracy of the documents I edit.
- How do you contribute to process improvement in editorial work? Provide an example of a process improvement tool or procedure you have developed or revised to enhance the efficiency or quality of editorial tasks. Answer: As a Senior Medical Editor, I actively contribute to process improvement initiatives. For example, I developed a standardized checklist to streamline the copyediting process, ensuring consistent application of grammar, punctuation, and style guidelines. This checklist reduced errors and improved overall efficiency. Additionally, I collaborated with the editorial team to revise internal policies and procedures, incorporating best practices and feedback from stakeholders. These efforts enhanced the quality and effectiveness of our editorial work.
- How do you manage complex medical writing projects as a project lead? Share an example of a project where you successfully coordinated internal team meetings, organized project requirements, and ensured effective distribution of information to meet project goals. Answer: As a Senior Medical Editor, I have led complex medical writing projects, ensuring smooth coordination and successful outcomes. In a recent project, I served as the project lead, responsible for scheduling and leading internal team meetings, organizing project-specific requirements, and ensuring efficient communication within the editorial team. By actively facilitating collaboration, distributing information effectively, and aligning team members towards project objectives, we achieved timely delivery of high-quality medical writing deliverables.
Editor’s Note: Syneos Health Life Sciences Medical Editor. Syneos Health Life Sciences Medical Editor Job Opening – Apply Online. Syneos Health Life Sciences Jobs. Please make sure that you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of all of the latest in the industry. Follow us on all of our social media like Twitter, Telegram, Facebook and Instagram.