Senior Medical Editor. FSP Spain. Must have previous clinical editing exp.

Senior Medical Editor. FSP Spain. Must have previous clinical editing exp.

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
 
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
 
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 deliver – for one another, our customers, and, most importantly, for those in need.
 
Discover what your 25,000 future colleagues already know:
 
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 building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. 
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. 

Job Responsibilities

This position is responsible for overall quality control (QC) review and submission-ready publishing of nonclinical documents. The Senior Medical Editor will copy, edit/proofread, format, and perform internal consistency review of document content in accordance with company SOPs and processes to ensure documents meet required standards. This role will support all documents written by authors from Drug Metabolism and Biopharmaceutics (DMB), Chemistry Manufacturing and Controls (CMC), Toxicology (Tox), and Translational Sciences. This position may also assist in clinical document QC and publishing tasks when appropriate to meet submission timelines. The Senior Medical Editor performs the activities with minimal oversight needed.

• Perform QC review of documents (eg, clinical study protocols and amendments, clinical study reports [CSRs], Investigator's Brochures, and Module 2 clinical summary documents) to ensure compliance with the client Style Guide and submission standards.
• Verify data in documents against the source tables, figures, and listings and format tables according to the client standards.
• Copyedit/proofread clinical documents for grammar, style, and formatting according to AMA and the client style guides.
• Ensure internal consistency and confirm that data are reported correctly, statements accurately reflect source documents or data (eg, SAS tables and listings).
• Check reference list in documents, including verifying citation information vs PubMed, ordering copies of references and adding to the electronic document management system (EDMS), and ensuring each reference is cross-referenced in the document.
• Proofread documents against the standard templates to ensure compliance with required sections and text.
• Perform publishing of nonclinical and clinical documents and the compilation of required CSR appendices, as needed.
• Lead and actively participate in process improvement initiatives and assist Medical Writing staff with other tasks, as appropriate.
• May oversee the workload for the editors, establishing schedules and interacting with cross-functional authors.
• Assist with training of more junior editors or contract staff.

Qualifications:

• Bachelor’s degree in English, Basic Science, Business, or other analytical field with 4 years related experience in the pharmaceutical industry OR 8+ years of experience in a discipline directly related to document production (eg, medical writing, QC, editing, publishing).
• Strong working knowledge of the editorial and publishing activities within Clinical Development.
• Proficient in Microsoft Word, including the ability to format tables, insert cross-references, apply styles, and use templates.  Experience with PowerPoint, Excel, Visio, Adobe.
• Strong working knowledge of Adobe PDF bookmarking and internal/external hyperlinking to meet submission-ready standards.
• Experience in the use of an EDMS (eg, Veeva Vault or SharePoint).
• Ability to effectively communicate with vendors and manage outsourced editorial work.
• Keen attention to detail.
• Ability to manage multiple activities, prioritize effectively, and work in a fast-paced, deadline-driven environment.
• Strong organizational and time management skills.
• Strong verbal, written, and interpersonal communication skills.

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.

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.