Principal Medical Writer

Medical Writing Reading, United Kingdom


Description

Position at Premier Research

Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.

We’re looking for an exceptional Principal Medical Writer to bring your passion to our team. You will be encouraged to grow professionally and personally while enjoying cross-functional partnerships with genuinely supportive colleagues, regardless of location or seniority. Most importantly, you will be using your skills to bring tangible hope to critically ill patients around the world.  

At Premier Research, we are science-minded and heart-centered. Join us.


ACCOUNTABILITY:

The Principal Medical Writer:

  • Ensures standards of writing, editing, reviewing, and formatting documents that conform to domestic and international regulatory submission and internal document standards, while meeting project timelines
  • Carries out responsibilities with minimal supervision
  • Participates in the document QC process, reviewing documents in a thorough manner for organization, clarity, consistency, use of English language/grammar, conformance with regulatory requirements, and scientific standards; ensures the document consistency with source documents and statistical output
  • Plans and manages the hours available to perform the necessary medical writing tasks for each assigned project
  • Actively supports clinical project team in representing Medical Writing (MW), and takes responsibility for timely and accurate MW deliverables, negotiating timelines
  • Drives effective collaborations with other functional areas
  • Performs additional duties when functioning as the project manager (ie, for projects with no clinical project manager) such as acting as a liaison with the sponsoring company and other internal departments, monitoring project progress, and problem solving with internal departments and sponsor
  • Works on multiple projects and/or project teams concurrently in collaboration with project managers and sponsors
  • Ensures timeline adherence for each assigned project and foresees issues that may potentially interfere with agreed timelines
  • Takes the lead in writing complicated assignments and as lead writer, plans and manages the documentation process, project timelines (in collaboration with Project Management), and resource requirements
  • Ensures consistent implementation of medical writing standards and SOPs
  • Incorporates comments provided by key stakeholders (including statisticians, project managers, data managers, medical reviewers, and peers) into documents in development
  • Demonstrates a broad understanding of scientific methodology and research design
  • Takes the initiative to facilitate and participate in document review meetings with the sponsor, to determine the most appropriate presentation and interpretation of study results.

RESPONSIBILITIES:

For regulatory documentation success:

  • Liaises as a MW department representative with members of the project team and provides experienced medical writing leadership
  • Provides quality control (QC) reviews of all regulatory documents
  • Works within the project team to keep supervisor, team, and reviewers informed of progress in document development; provides project managers with periodic document status reports

For commercial success:

  • Ensures sponsor and internal client expectations are clearly delineated and are met or exceeded in a timely manner.
  • Provides information to implement change orders for all department-related activities as needed

Other

  • Provides in-house trainings on relevant topics and issues
  • Reviews and provides feedback on draft statistical analysis plans (SAPs), data listings prior to database lock, and draft tables, listings, and figures reviews
  • Interprets and trains others regarding current regulatory guidelines pertaining to regulatory documents
  • Mentors other more junior medical writers, providing constructive feedback
  • Participates in corporate initiatives and actions that ensure the continued success of the company
  • Other activities as designated

EDUCATION, SKILLS & COMPETENCIES:

Educational Background

  • Has an undergraduate degree or higher from an accredited institution or is a licensed healthcare professional.
  • Advanced degree in life sciences preferred

Experience

  • Has 10+ years of increasingly responsible medical writing experience in a pharmaceutical company or a contract research organization
  • Assists with mentoring and training staff
  • Works with internal and external customers/vendors to meet project‑specific goals
  • Manages time and project requirements based on study contract
  • Maintains consistent adherence to Premier processes and SOPs
  • Maintains current knowledge of ICH and local regulatory authority drug research and development regulations
  • Determines, tracks, and reviews milestones, tasks, timelines, and project hours for all the activities for assigned projects, ensuring adherence to contract and budget
  • Ensures that all tasks meet expectations, and are delivered in accordance with the contract, trial protocol, ICH/GCP, and applicable SOPs

Expertise and know-how

  • Knowledge of ICH/GCP regulations
  • Excellent command of written and verbal English
  • Working knowledge of FDA Guidance Documents/EU Directives/ISO14155 regulations, drug/device development, and relevant regulatory‑writing style, consistent with the most recent American Medical Association Manual of Style, and the Premier Style Guide
  • Knowledge of web‑based communication conferencing tools
  • Expert level proficiency in the use of various computer software applications including Microsoft Word, Excel, Project, and Adobe
  • Intermediate to advanced knowledge of biostatistical and clinical research concepts, especially clinical study design
  • Intermediate to advanced understanding of the drug, biologic, and medical device product development process
  • Ability to work with focus and attention to detail

Personal skills & behaviours

  • Excellent team player, collaborative, and able to build an effective team
  • Ability to multitask and work effectively in a fast-paced environment with changing priorities
  • Strong verbal and written communication and negotiation skills
  • Excellent organisational and time-management skills, able to prioritize work to meet deadlines
  • Exhibits flexibility and responsiveness in dealing with internal and external clients
  • Accountable, dependable, transparent, and strongly committed to the goals of the Medical Writing department
  • Is customer‑service focused in approach to work both internally and externally
  • Maintains a positive, results‑orientated work environment
#LI-JD1