Overview

Do you want to work in an environment and culture where you can thrive, develop and advance?

A career with Kinapse means your everyday work improves patients’ lives around the world. We are a values driven company with a supportive and flexible culture. You will work in a collaborative environment with team members who share their expertise and knowledge. Your personal and professional development will be front and center. We can offer you a fulfilling and challenging career working with smart, yet humble professionals. We reward and recognise our people by providing valuable benefits and a quality of life balance.

An opportunity has arisen for a Senior Medical Writer to author, edit and peer review medical writing documents supporting the analysis, reporting and publication of clinical data and information. The role can be home based.

Responsibilities

• Independently author or lead authoring, including editing of documents such as:
  • Clinical study documents or documents for regulatory submission e.g., protocols, clinical study reports, patient narratives, investigator brochures
  • External scientific communications e.g., manuscripts, abstracts, standard response documents, FAQs, response to authorities
  • Results summaries to support clinical trial disclosure commitments
• May independently author or lead authoring complex documents such as INDs, clinical summaries and overviews, briefing documents, response to authorities and PIPs.
• Participate in and potentially lead meetings with clients as required to understand expectation, establish trust and confidence with client counterparts.
• Provide quality assurance and training, and may provide technical mentoring of team members.
• Support work allocation and provide oversight to team members in execution of their project responsibilities.
• As a Subject Matter Expert, may provide internal advice on Development Operations services based on expertise to support business development and training.
• Systematically review or perform quality control checks of documents prepared by junior colleagues against pre‑specified check‑lists and follow‑up independently until final submission, or as assigned.

Job Requirements

• Degree, or advanced level degree in a life science discipline.
• Experience and technical skills within Medical Writing or Medical Information, as a part of a pharmaceutical company or CRO.
• Experience of authoring protocols, clinical study reports, patient narratives, investigator brochures.
• Significant knowledge of regulatory requirements or guidance pertaining to medical writing or medical Information.
• Strong knowledge of basic computer applications, e.g. MS Word/PowerPoint/Excel.
• Excellent verbal and written communication skills.

 If you want to be part of a progressive, forward-thinking company and want to make a difference then we want to hear from you.

We believe that Diversity & Inclusion are central to a dynamic, exciting and innovative organization. To review our D&I policy please visit https://kinapse.com/diversity-inclusion