Job Details

Overview
You love a good challenge. You are the first to roll up your sleeves and work with relentless energy until you solve the unsolvable, beat the unbeatable and you always come out on top. Passable doesn’t cut it – you’ve got fire in your belly to learn more, do more and be more. For you, the sweetest success is shared success and you’re known for your good nature. You’ll fit right in at Syneos Health where we surround ourselves with the most talented and agile professionals in the industry, but we check our egos at the door.

Working as part of a high performing team the senior medical writer is responsible for authoring, editing and peer review of medical writing documents supporting the analysis, reporting and publication of clinical data and information to deliver above and beyond the client’s expectations for quality, efficiency and productivity.

Responsibilities

• • Undertake project specific activities at high quality and witihin defined timelines according to defined standard processes and operating procedures
  • Independently authors or leads 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 of complex documents such as INDs, clinical summaries and overviews, briefing documents, response to authorities, and PIPs

• Provides quality assurance and training, and may provide technical mentoring, of team members depending upon project requirement
• Supports work allocation and provides oversight to team members in execution of their project responsibilities
• As a Subject Matter Expert (SME), may provide internal advice on Development Operations services based on expertise to support business development and training
• Participates in recruitment when required

Displays and supports Kinapse values and expected behaviours related to team working and projects

Job Requirements

• Active, continuous demonstration of the Kinapse values
• 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
• Strong analytical capabilities, familiarity and comfort with scientific and clinical data
• Commitment to ensuring the highest quality outputs are provided, including high attention to detail
• Strong knowledge of basic computer applications, e.g., MS Word/ PowerPoint/ Excel
• Significant knowledge of regulatory requirements or guidance pertaining to medical writing or medical Information
• Demonstrate the ability to impart knowledge of industry or functional terminology to other team members
• Effective team member, and matrix leader for small teams
• Excellent relationship building, and communication skills
• Integrity, credibility, and commitment to building the Kinapse brand in the marketplace
• Excellent client relationship management skills, professional service mentality