Logo of Huzzle

Home

Matches

Explore

Manage

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

image

Syneos Health Commercial Solutions

14d ago

  • Job
    Full-time
    Senior Level
  • Research & Development
    Healthcare
  • Madrid
    Remote

AI generated summary

  • You need a Bachelor's in English or Science, solid medical writing and QC experience, proficiency in Microsoft Office and Adobe PDF, and strong attention to detail in clinical documentation.
  • You will perform QC reviews of clinical documents, copyedit for style and accuracy, verify data, manage schedules, and assist in training junior editors while ensuring compliance with standards.

Requirements

  • 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 within 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.

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.

FAQs

What is the job title for this position?

The job title is Sponsor Dedicated Senior Medical Editor (QC of clinical documents) - Home Based Several Locations in EU.

What are the main responsibilities of the Senior Medical Editor?

The main responsibilities include quality control (QC) review of clinical documents, copyediting/proofreading, verifying data content, formatting, and ensuring compliance with company SOPs and standards.

What type of documents will the Senior Medical Editor review?

The Senior Medical Editor will review clinical documents such as clinical study protocols, amendments, clinical study reports (CSRs), Investigator's Brochures, and Module 2 clinical summary documents.

What qualifications are required for this position?

A Bachelor's degree in English, Basic Science, Business, or a related analytical field, along with solid experience in the pharmaceutical industry in medical writing, QC, editing, and publishing of clinical documents is required.

Is prior experience in document QC necessary?

Yes, document QC experience, particularly with clinical protocols, clinical study reports, and Investigator's Brochures is necessary.

What software skills are essential for this role?

Proficiency in Microsoft Word, PowerPoint, Excel, Visio, Adobe, and experience with Adobe PDF bookmarking and hyperlinking, as well as familiarity with an electronic document management system (EDMS) is essential.

Will the Senior Medical Editor have any oversight responsibilities?

Yes, the Senior Medical Editor may oversee the workload for editors, establish schedules, and interact with cross-functional authors.

Are there opportunities to assist with training other staff?

Yes, the Senior Medical Editor may assist with the training of more junior editors or contract staff.

What is Syneos Health's commitment regarding employee culture?

Syneos Health is committed to a Total Self culture, promoting authenticity and inclusivity within the workplace.

Is this position fully remote?

Yes, this position is home-based, allowing for flexibility across several locations in the EU.

Does this role require strong attention to detail?

Yes, a keen attention to detail is essential for ensuring the accuracy and compliance of clinical documents.

How does Syneos Health support employee development?

Syneos Health supports employee development through career progression opportunities, technical training, peer recognition, and a total rewards program.

Is there an emphasis on diversity at Syneos Health?

Yes, Syneos Health values diversity of thoughts, backgrounds, cultures, and perspectives, fostering a workplace where everyone feels they belong.

image

Syneos Health Commercial Solutions

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

Syneos Health® (Nasdaq:SYNH) is the only 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. We bring together a talented team of professionals, who work across more than 110 countries, with a deep understanding of patient and physician behaviors and market dynamics. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. Syneos Health supports a diverse, equitable and inclusive culture that cares for colleagues, customers, patients, communities and the environment.