TransPerfect

Principal Medical Writer

ID
2017-9270
Category
Document Management
CH-Zurich
ES-Barcelona

Responsibilities

Summary

TransPerfect Trial Interactive (TI) is seeking outstanding and diverse candidates to help our clients operate more effectively in the global marketplace. If you have a sense of urgency, a passion for client service, and a desire to help the world's leading global firms conduct business more effectively, TransPerfect Life Sciences could be the place for you. If you think you have what it takes to join the most enthusiastic and client-focused team in industry, drop us a line. We'd love to hear from you!

The Principal Medical Writer is responsible for providing scientific publications or clinical regulatory document support and advanced scientific writing expertise to the clinical teams, ensuring successful preparation of high quality submission-ready documents and effective implementation of the writing process. Provides medical writing expertise for multiple compounds and/or projects within a therapeutic area. Interfaces with external groups (e.g. PK, Toxicology, eSubmissions, Regulatory, Statistical Support, Data Management, Clinical, Publishing) to ensure accurate and timely completion/delivery of information and review of scientific publications or clinical regulatory submissions. Serves as the scientific writing content expert for the department. As a successful candidate you will have an extreme sense of urgency and superior attention to detail.

 

Responsibilities:

  • Serves as medical writing lead on complex scientific publications or clinical regulatory documents such as those associated with filings and dossiers
  • Works closely with the Publications or Regulatory team(s) on document strategies. Implements all activities related to the preparation of scientific publications
  • Converts relevant data and information into a form that meets clinical regulatory document requirements
  • Responsible for effective communication among team members and identifying and resolving conflicts to ensure teams achieve project goals
  • Understands and complies with appropriate conventions and other governing bodies following applicable divisional guidelines, templates, and SOPs
  • Works with Regulatory Quality Assurance throughout clinical regulatory document audit process and works with team to draft responses as necessary
  • Maintains expert knowledge of US and international regulations (maintain certifications)
  • Serves as a department representative on project teams
  • Acts as Subject Matter Expert eDocs, eCTD, and journal/congress databases
  • Coaches, mentors, and assists medical writers
  • Recommends, leads, and implements tactical process improvements, both within the department and division-wide
  • Drafting of SRLs (including the PML safety update) – create/update SRLs as needed, formatting new content according to approved templates
  • Occasional international and domestic travel required for industry related conferences

Qualifications

About You:

As a Principal Medical Writer, you are a:

  • Creative thinker – You are curious and unafraid to ask questions
  • Hard worker – You are industrious and diligent in everything you do
  • Innovator – You are willing to initiate changes and introduce new ideas

Your experience includes:

  • Bachelor of Degree from year university
  • Masters or PhD in science discipline with relevant writing experience (preferred)
  • American Medical Writing Association (AMWA) or International Society for Medical Publication Professionals (ISMPP) certification preferred
  • 4 years relevant industry experience in medical writing
  • Experience writing high-level content for clinical publications or clinical regulatory documents
  • Experience in assimilation and interpretation of scientific content  
  • Working knowledge of statistical concepts and techniques
  • Excellent written and oral communication skills
  • Advanced experience in word processing, flow diagrams, and spreadsheets.
  • Experience in working with collaborative, cross-functional teams

Overview

About Us:

For more than 20 years, TransPerfect has provided comprehensive language and technology solutions to help our clients communicate and conduct business more effectively in a global marketplace. Equipped with a quality management system certified to both the ISO 9001:2015 and ISO 17100:2015 standards, TransPerfect provides a full array of language and business support services, including translation, interpretation, multicultural marketing, website globalization, subtitling, voiceovers, staffing services, multicultural marketing, e-learning and training, and legal support services. TransPerfect also offers a suite of next-generation technologies that significantly reduce costs and improve consistency throughout the translation process, making TransPerfect the vendor of choice for the world's leading multinationals.

 

TransPerfect Life Sciences Solutions has helped life sciences companies conduct clinical development and commercialize products on a global scale. We bring that same level of expertise to our secure, web-based e-clinical solution, Trial Interactive. Trial Interactive enables life sciences companies to streamline the execution and commercialization of global clinical trials and collaborate on partnerships while reducing administrative burdens.

With annual revenues of over $550 million, TransPerfect is the world's largest privately held provider of language services and technology solutions. From offices in more than 90 cities on six continents, TransPerfect offers a full range of services in 170+ languages to clients worldwide. With an unparalleled commitment to quality and client service, TransPerfect is fully ISO 9001 and ISO 17100  certified. TransPerfect has global headquarters in New York, with regional headquarters in London and Hong Kong.

 

For more information on the Trial Interactive, please visit our website at www.trialinteractive.com.

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