Sr. Medical Editor

Lexington, MA

Contract

apply now

OVERVIEW

We are currently searching for a skilled professional to join a well-known client’s team as Senior Medical Editor in Lexington, MA.  Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity.

RESPONSIBILITIES

  • Formatting all clinical documents ensuring compatibility with requirements for electronic publishing and submission to regulatory agencies
  • Editing clinical study reports, Clinical overview, clinical summaries, ISS, ISE, investigator brochures, protocols and amendments, sample informed consent forms, and other documents related to client’s clinical studies
  • Creating VDocs in electronic document management system and compiling medical writing documents, as needed and ensuring submission-readiness prior to transfer to regulatory publishing group
  • Preparing and maintaining electronic templates for clinical study regulatory documents
  • Pre-/post-publishing checks of the regulatory submissions
  • Developing and maintaining guidelines on style and document publication-readiness
  • Supporting the development of Clinical Scientific Affairs processes and guidelines
  • Editing manuscripts (for publication in peer-reviewed journals) and posters
  • Creating graphics, flowcharts, and related items for manuscripts, posters and other publications.
  • Providing support for systems for the management of clinical documents prepared by Clinical Scientific Affairs
  • Supporting the life-cycle management of the clinical documents
  • Ensuring compliance with departmental Standard Operations Procedures
  • Working closely with various clinical teams on assigned projects to ensure adherence to departmental timelines
  • Acting as liaison with regulatory publishing group to support submission-readiness and electronic submission compliance of clinical documents
  • Working with the Administration of Clinical Scientific Affairs´ SharePoint site and the data/document exchange partnership sites
  • Acting as a subject matter expert for electronic document management system
  • Assisting in the dictionary administrator for electronic documents management system
  • Assisting in the oversight over outsourced editing tasks

EXPERIENCE

  • 3 years of experience with editing, formatting, or publishing with prior experience in a pharmaceutical company preferred
  • Expertise in electronic editing, electronic formatting, document management, and publishing
  • Ability to manage and administrate the electronic document management system and SharePoint sites
  • Knowledge and understanding of International Conference on Harmonization and Food and Drug Administration guidelines
  • Knowledge of computer software and meticulous attention to detail

EDUCATION

  • Bachelor’s Degree 

To be a best-fit your strengths must include

  • Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology
  • Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines
  • Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure
  • Problem-Solvers.  As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges
  • Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives
  • Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource

About Advanced Clinical

Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.

Regarding your application

Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.

Google Ads

847-267-1176

Google Tags Manager Footer