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Medical Editor Ii. Spain. Sponsor Dedicated
hace 3 meses
Description
Medical Editor II
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.
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 crossdepartmental 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.
- 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.
- Performs data integrity review of assigned documents to ensure accuracy.
- 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.
- Relevant publishing experience using Adobe Acrobat or other appropriate markup language preferred. ISIToolbox experience preferred.
- 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 teamoriented skills.
- Excellent grammatical and communication skills, both written and oral.
- Familiarity with the AMA style guide strongly preferred.
- Ability to work with mínimal 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.
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 legis