Premier Research - Senior Medical Writer & Manager, Medical Writing

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Discover your value at Premier Research, a global, full service CRO.

At Premier Research, what we do is profoundly connected to saving and improving lives. And we can’t do it without you – YOU make all the difference.

As an expert, a teammate, a leader – your work at Premier Research will transform the future of health care. That’s why our staff members are our most valuable asset. When our staff is at their best, it means a better, healthier future for everyone.

Help us turn amazing science into life-changing therapies for those in critical need. We are committed to providing you with the opportunities, tools, and benefits you need to be successful.

Our Medical Writing Team is growing, and we have the following opportunity available:

Senior Medical Writer – Europe – Remote / Hybrid

We’re looking for a Senior Medical Writer to join our Medical Writing team that is passionate about improving healthcare through innovative clinical research. As a member of the Premier Research team, you’ll help create tangible solutions for patients in need while building cross-functional partnerships that enable your growth and success.

We can consider hiring this opportunity in any location across Europe where we have an office presence.  We can accommodate office based; home based of a hybrid mix.

The Senior Medical Writer is responsible for authoring and managing the review and approval of moderate and complex clinical and regulatory documents including but not limited to clinical study reports, protocols, investigator brochures, clinical sections of the Common Technical Document, and other clinical documents.  Converts scientific data into clear, scientifically sound, well-structured regulatory documents intended for global health authorities and stakeholders, in accordance with relevant styles and guidelines. This role provides guidance and mentoring to the Associate Medical Writer and Medical Writer I/II positions.

What you'll be doing:

  • Project manage assignments
  • Independently write and format clinical and regulatory documents
  • Review and approve clinical and regulatory documents including, but not limited to: synopses and protocols, clinical study reports, in-text tables, appendices, addendums, study plan outlines, and documents for regulatory submissions (e.g., Investigational New Drug applications, sections of marketing applications, investigator brochures, or other clinical and regulatory documents)
  • Ensure timeline adherence for each assigned project, provide project status updates on a regular basis, and carry out contractual obligations for each assigned project
  • Work 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 clients
  • Interpret and summarize clinical data as needed to prepare documents
  • Review all source documents, perform literature searches, and interact with internal team members and external clients to develop a thorough understanding of project background, timelines, and goals
  • Advise clients on appropriate document preparation and the basic regulatory requirements of various types of documents
  • Aid in study design during protocol development and regulatory compliance throughout all documents
  • Write Integrated Summaries of Safety and Efficacy (ISS and ISE), and guide more junior writers to assist in their preparation
  • Edit and perform quality control reviews for documents for other Medical Writers
  • Identify and solve problems relating to medical writing issues
  • Coordinate with internal team members to develop deliverables for clients
  • Contribute to the development and maintenance of the working practices, procedures, and templates for the Medical Writing department
  • Assist in the review of statistical analysis plans prior to database lock and provide feedback to the team when appropriate
  • Effectively facilitate data and document review meetings with internal teams and clients, as necessary
  • Manage the efforts of other writers and mentor more junior writers

What we are searching for:

  • Bachelor’s degree, or international equivalent, from an accredited institution in a scientific discipline, journalism, or English; MS or PhD in a scientific or medical discipline preferred
  • BA/BS and demonstrated experience in medical/regulatory writing; or MS coupled with proven experience in medical/regulatory writing; or PhD and experience in medical/regulatory writing
  • International experience desirable
  • Depth of industry and drug development knowledge
  • Expert in literature search techniques
  • Strong knowledge and experience with Common Technical Document content templates as well as content expectations for IND/NDA/BLA/MAA and other regulatory documentation
  • Superior working knowledge of software programs in Windows environment with excellent proficiency in word processing, flow diagrams, and spreadsheets
  • Ability to learn fast, to convert relevant scientific data/information into high quality summaries and reports
  • Excellent organizational, writing, communication, and time management skills needed to manage multiple ongoing projects and/or other writers simultaneously
  • Well-developed analytical skills and strong knowledge of medical terminology
  • Experience across various therapeutic areas and phases

How to apply:

Please submit your application via our career portal on the link below:

Careers > Premier Research (premier-research.com)

For any queries about this role, please contact jane.dawkins@premier-research.com

For more information about our organization, please visit our website https://premier-research.com

Manager, Medical Writing – Reading, Berkshire – Remote / Hybrid

What you'll be doing:

Responsible for the creation of written scientific documentation associated with the clinical trial process including, but not limited to, Clinical Study Reports (CSRs), Protocols, Investigator Brochures (IBs), other regulatory documents, manuscripts, and/or poster, slide, or oral presentations. Responsible for costing medical writing proposals, and for developing project plans and project assignments for all direct reports.

  • Oversees the day-to-day activities of direct reports
  • Writes, edits, and performs quality control (QC) reviews for CSRs, protocols, and IBs
  • Assists in writing 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 documents generated by other medical writers in the department and provides constructive feedback (mentoring)
  • Assists in the review of draft case report forms (CRFs), statistical analysis plans (SAPs), and in blinded data listing reviews prior to database lock and provides feedback to the team when appropriate
  • Conducts background research as necessary for each assigned project, including literature searches
  • Participates in document review meetings with the sponsor to determine the most accurate and appropriate protocol design or interpretation of study results
  • Provides project status updates on a regular basis
  • Is responsible for resource planning and allocation as well as selection of new staff

What we are searching for:

  • Bachelor’s degree (or equivalent) in the medical sciences, journalism, or English (MS or PhD preferred)
  • Demonstrated medical/technical writing or clinical research experience
  • Proven supervisory experience 
  • Ability to create and manage large electronic files and documents
  • Requires analytical skills and extensive knowledge of medical terminology
  • Ability to facilitate a project team meeting with internal and external team members
  • Familiarity with Microsoft Office as well as Adobe tools (software) and computer graphics

Why choose Premier Research?  

  • Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.  
  • Our cultural anchors – Caring & Empathy, Empowerment, Aspiration, One Team – mirror the flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location. 
  • Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.

How to apply:

Please submit your application via our career portal on the link below:

Careers > Premier Research (premier-research.com)

For any queries about this role, please contact jane.dawkins@premier-research.com

For more information about our organization, please visit our website https://premier-research.com

Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.

We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.

Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability, or veteran status.