Medical Writing Editor

7 days ago

King of Prussia, United States CSL Behring Full time

CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.

With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring, CSL Plasma, CSL Seqirus and CSL Vifor. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions.

Could you be our next Medical Writing QC Editor? You will be hybrid in our King of Prussia PA, Marburg Germany, Maidenhead UK or Bern Switzerland office.

You will be a member of the Quality and Publishing team in the Medical Writing department. You will report to the Quality and Publishing Senior Manager. Under the general management of the Senior Manager you will work with Medical Writers and be responsible for editorial support of clinical regulatory documents created by in-house Medial Writers and by Medical Writing vendors to produce high-quality documents and ensure that documents follow internal and global quality standards and follow electronic publishing standards.

What to Expect:

  • Provide editing and styling / formatting support to Medical Writers for clinical regulatory documents (eg, CTD Submission documents, Clinical Study Protocols, Investigator's Brochures, Clinical Study Reports, Clinical Study Outline, etc).
  • Edit to align according to department's Style Guide, document-specific template, and publishing requirements.
  • Document is styled and formatted throughout the document and related documents (eg, StartingPoint Styles are used throughout the document).
  • Provide editing support to other tasks (other clinical / regulatory documents [eg, SAP, CDP, Briefing Book]).
  • Follow guidelines, SOPs, practices, and industry standards during all aspects of work.
  • Support developing and reviewing standard processes and templates.

Requirements:

  • 3+ years of editing experience in pharma and / or healthcare industry.
  • Advanced document formatting and editing knowledge in Microsoft Word (MS Office suite).
  • Proficient in StartingPoint Templates suite and styles.
  • Proofreading skills.
  • Proficient in Adobe Acrobat.
  • Basic familiarity of the drug development process and Good Clinical Practice (GCP).
  • Familiar with the AMA Manual of Style.
  • Experience using Regulatory / Electronic Document Management Systems (eg, Documentum).
  • Experience with ISI toolbox and publishing.

BENEFITS

  • Medical, Dental Vision
  • 401K
  • Paid time Off

#LI-Hybrid

Our Benefits

CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.

Please take the time to review our benefits site to see what’s available to you as a CSL employee.

About CSL Behring

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

We want CSL to reflect the world around us

As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

Do work that matters at CSL Behring

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