Senior Medical Writer - Remote

Medical Writing Bratislava, Petr┼żalka


Description

Position at Premier Research

Bring your Passion to Premier! 

Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality. We have positioned ourselves right in the middle of the action, targeting unmet needs in Rare Disease and Pediatrics, Analgesia, Neuroscience, Oncology, Dermatology, and Medical Devices

We're looking for a talented and energetic Senior Medical Writer to join our team!

Working at Premier Research means being an individual - you will be recognized for what you do and you will truly have an impact in an aspiring, empowering and caring culture where people truly work as one team. You can grow and contribute your expertise with colleagues who are genuinely supportive regardless of location or seniority.  Premier Research is on an exciting journey - there is a true buzz throughout the company, so come and be part of it!

As the Senior Medical Writer you will be responsible for writing Clinical Study Reports (CSRs), Protocols, Investigator Brochures (IBs), as well as a variety of other regulatory documents including, but not limited to, Investigational New Drug Applications (INDs) and New Drug Applications (NDAs), manuscripts, and/or poster, slide, or oral presentations.

What you'll be doing:

  • Writes, edits, and performs quality control (QC) reviews for CSRs, protocols, and IBs
  • Writes Integrated Summaries of Safety and Efficacy (ISS and ISE), New Drug Applications (NDAs) and other regulatory documents necessary for regulatory submission
  • Writes and develops manuscripts and/or posters for publication
  • Creates slides for oral presentations
  • Creates in-text tables and word processing
  • Compiles document appendices, attachments, etc.
  • Reviews draft case report forms (CRFs), statistical analysis plans (SAPs), and blinded data listing reviews prior to database lock and provides feedback to the team when appropriate
  • Reviews documents generated by other medical writers in the department and provides constructive feedback (editing as needed)
  • Conducts background research as necessary for each assigned project, including literature searches
  • Works on multiple projects and/or project teams at one time (dependent on complexity and time commitment for each project) in collaboration with project managers and sponsors
  • Participates in document review meetings with the sponsor to determine the most accurate and appropriate protocol design or interpretation of study results
  • Interprets and trains other staff members regarding current regulatory guidelines pertaining to regulatory documents
  • Interprets scientific literature
  • Ensures timeline adherence for each assigned project
  • Facilitates a team approach for each assigned project
  • Provides project status updates on a regular basis
  • Carries out contractual obligations for each assigned project based on the sponsor proposal
  • Demonstrates an understanding of experimental methods and research design
  • Attends meetings (proposal, kickoff, etc.) with prospective sponsors when necessary
  • Takes the lead for writing complicated assignments
  • Assists in the creation of study templates, review forms, and guidance documents

OTHER RESPONSIBILITIES:

  • Maintains a working knowledge of departmental Standard Operating Procedures (SOPs) and International Conference on Harmonization (ICH) guidelines
  • Exhibits professional conduct at all times
  • Serves as mentor and trainer for members of the Medical Writing Department
  • Serves as a core team member to design, review, and/or sign-off on major study documents
  • Identifies and solves problems relating to medical writing issues
  • Effectively facilitates meetings as necessary
  • Expert in literature search techniques
  • Participates in and may lead in staff, departmental, and company meetings
  • Adheres to required Premier Research training plan

You'll need this background to be considered:

Key Skills:

  • Requires excellent typing skills, ability to use templates, and the ability to create and manage large electronic files and documents
  • Requires analytical skills and extensive knowledge of medical terminology
  • Demonstrates excellent written and verbal skills
  • Requires excellent communication skills
  • Consistently demonstrates the ability to work independently and in a team environment
  • Demonstrates the ability to facilitate a project team meeting with internal and external team members
  • Works independently and fosters others to work in a team environment
  • Adapts to changes in priorities and timelines
  • Demonstrates strong problem-solving skills

Experience:

  • Five years experience in medical/technical writing

Or

  • Four years combined experience in medical/technical writing or clinical research
  • Two years experience in medical/technical writing if PhD

Education (Degree) or certifications:

  • Bachelor’s degree in the medical sciences, journalism, or English (MS or PhD preferred)