Sponsor Dedicated Senior Medical Editor (QC of clinical documents) - Home Based Several Locations in EU

Description

Sponsor Dedicated Senior Medical Editor (QC of clinical documents) - Home Based Several Locations in EU

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 29,000 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

This position is responsible for quality control (QC) review of clinical documents intended for submission to health authorities worldwide.  The Senior Clinical Editor will copyedit/proofread, format, and verify data content in clinical documents in accordance with company SOPs and processes to ensure documents meet required standards, and may oversee the workload for the editors, establishing schedules and interacting with cross-functional authors.  The Senior Clinical 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 Incyte Style Guide and submission standards.
- Verify data in documents against the source tables, figures, and listings and format tables according to Incyte standards.
- Copyedit/proofread clinical documents for grammar, style, and formatting according to AMA 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

What we’re looking for

Bachelor’s degree in English, Basic Science, Business, or other analytical field with solid experience in the pharmaceutical industry in medical writing, QC, editing, publishing of all clinical documents.

• Strong working knowledge of the editorial and publishing activities within Clinical Development.
• Document QC experience (eg, clinical protocols, clinical study reports, investigator’s brochures).
• The submission publishing task experience should be in creating bookmarks and hyperlinks withing a single PDF document as well as external hyperlinks to multiple PDF documents
• 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.

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.

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