Job Vacancy Gurugram, Haryana, India Position Medical Editor II, Quality Assurance at サイネオス・ヘルス

Description

Medical Editor II (Quality Check)

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

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 29,00 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

JOB RESPONSIBILITIES

• Must have min 1 year of ME experience

• Should have experience in data and content QC review.

• Should have experience reviewing extracts, manuscripts, posters, and figure/table outputs (scientific QC).

• Should have strong knowledge of relevant guidelines, along with a good understanding of deliverables and data QC processes.

• Conducts data integrity reviews of assigned documents to ensure accuracy and consistency across text, tables, and figures; accurate bibliography/in-text citation and alignment of figures/graphs as per branding guidelines

• Cross-checks scientific content against cited references to verify medical/scientific accuracy, ensure alignment with the approved product label, and maintain neutrality of data presentation in accordance with source material.

• Verifies correct interpretation of scientific data from referenced sources and ensure content alignment, formatting, and structure comply with internal style guides and journal or congress-specific guidelines.

• Ensures all statements are appropriately source annotated, with complete one-to-one alignment between in-text citations and the corresponding reference list.

• 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.

• Participates in internal and client-facing meetings, as required, to liaise with client stakeholders and

facilitate resolution of comments while ensuring alignment with stakeholder expectations and adherence to agreed timelines and submission deadlines.

• 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.

• 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.

• 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.

QUALIFICATION REQUIREMENTS

• Bachelor’s degree (preferred) in the life sciences, clinical sciences, or English/journalism; or copyediting, data integrity review, and/or relevant publishing experience.

• 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.

• 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.

Disclaimer:

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.

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 73,00 Sites and 675,00+ 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.

http://www.syneoshealth.com

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.

Summary

JOB SUMMARY Improves and ensures the quality of compliance or written deliverables through data integrity review, general editing, document management, and publishing support. May independently perform quality review, compilation, or publishing tasks for medical writing deliverables to ensure content integrity and consistency with customer and/or regulatory submission standards. Interacts with department heads and staff members throughout the company regarding assigned deliverables as appropriate.