Medical Writer

Position Overview:

The Medical Writer is an integral member of the Medical and Clinical Affairs team and will lead and/or participate in several dynamic workstreams including but not limited to scientific communication strategy, support of clinical and R&D initiatives, regulatory submissions and marketing priorities. The ideal candidate will have a deep understanding of scientific research, clinical development, and market dynamics in the field of urology. This position requires a highly collaborative team member who will work cross-functionally with R&D, regulatory, legal, clinical operations, and marketing. Excellent communication skills and the ability to perform independently in a fast-paced, dynamic environment are essential.

In this role, you will have responsibilities in these areas:

• Scientific Communication
  • Implementation and project management of the company’s scientific podium and publication plan with expected contribution to strategy
  • Creation and timely submission of high-quality peer-reviewed publications, abstracts and presentations covering all categories listed below
  • Build relationships with key opinion leaders (KOLs) to foster research collaborations and ensure timely abstract and publication submissions. In-person support of all KOL presentations at meetings is required
  • Development of deliverables including but not limited to white papers, op eds, and clinical summaries
• Clinical Pipeline Initiatives
  • Collaborate with clinical operations to support trial design, develop protocols, and ensure clinical data supports the company’s scientific objectives
  • Foster communication and alignment with clinical operations and other stakeholders to ensure trial execution is aligned with podium and publication plans. Work cross functionally to adjust timelines if/when milestones may be at risk elevating to leadership as needed
• R&D Projects
  • Support R&D teams and external partners to ensure scientific rigor in the development of preclinical research to clinical trials
  • Project management of the company’s preclinical research strategy, inclusive of adjoining communication plan, with expected contribution to strategy
• Regulatory Submissions
  • Provide medical writing for all FDA submissions
  • Write Clinical Evaluation Reports (CERs); oversee accompanying comprehensive literature review
• Marketing Initiatives
  • Collaborate with the marketing team to translate scientific data into compelling marketing messages and develop scientific content for promotional materials as needed
  • Support medical communications review by ensuring that all marketing materials are scientifically accurate and compliant with regulations
  • Support the scientific analysis of competitive landscape, identifying trends, emerging technologies, and potential threats in the urinary stone market
• Reimbursement and health economic initiatives
  • Project management of the company’s health economics outcomes research strategy, inclusive of adjoining communication plan, with expected contribution to strategy
  • In-depth participation of healthcare claims analyses including benchmark research and vendor identification
  • Continuously liaise with the reimbursement team to ensure clinical pipeline and outcomes meet foreseeable needs; align podium and publication plan accordingly
• Other requirements
  • Attend in-person team building events and contribute meaningfully
  • Attend society meetings as requested to ensure a successful podium plan and seek out immersive research presentations
  • Contribute to a culture of innovation, collaboration and scientific excellence
  • Perform additional activities as assigned by supervisor

Who You Will Report To:

• Director, Scientific Affairs

Requirements:

• Advanced degree, such as a PhD or MD with proven biostatistical training and application, in a relevant scientific discipline (e.g., Life Sciences, Pharmaceutical Sciences, Clinical Research, or similar fields)
• Minimum of 3.5 to 5 years of experience in scientific affairs, clinical research, or drug development within the medical device, pharmaceutical, or biotech industry, preferably in urology, nephrology, or related fields
• Strong publication record required with at least 1 first author publication. Please include publication record as part of your resume or CV
• Proven experience in scientific communications, including peer-reviewed publications, abstracts, and scientific presentations
• Demonstrated ability to interact with industry professionals and KOLs
• Experience managing clinical pipelines, regulatory submissions, and R&D projects a plus
• Experience in competitive intelligence and interpreting market trends a plus
• Strong strategic thinking and interpersonal skills with the ability to work in a fast-paced, dynamic start-up environment
• Exceptional written and verbal communication skills, with the ability to translate complex scientific data into clear, concise messaging for diverse audiences
• Ability to work independently with sound autonomous decision making
• Work location: Pleasanton, CA. Hybrid (minimum 3 days a week in the office)
• Travel: Up to 25%
• Full-time employment
• Responsible for performing all duties in compliance with FDA’s Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which the company complies
• Compliance with relevant county, state, and Federal rules regarding vaccinations

What We Offer:

At Calyxo, you will be part of a knowledgeable, high-achieving, experienced and fun team.  You will work in a diverse work environment with experienced, proven leaders and have an opportunity to shape our company culture.  You will experience constant learning and dynamic challenges to help you grow and be the best version of yourself. 

We also offer a compensation plan as follows:

• Competitive base salary of $120,000 - $140,000
• Stock options – ownership and a stake in growing a mission-driven company
• Employee benefits package that includes 401(k), healthcare insurance and paid time off