Manager/Sr. Manager, Medical Writing

Manager/Sr. Manager, Medical Writing

About KalVista Pharmaceuticals

KalVista Pharmaceuticals, Inc. (http://www.kalvista.com) is focused on the discovery, development, and commercialization of novel, oral therapies for diseases with significant unmet need, with an initial focus on hereditary angioedema (HAE). Listed on the Nasdaq Global Market, our headquarters is located in Cambridge, MA with additional offices and laboratories in Salisbury, UK; Zug, Switzerland; and Salt Lake City, UT.

The company has an R&D team with an established track record in the pharmaceutical development of small molecule protease inhibitors, world-leading expertise in the role of plasma kallikrein in disease, and a management team with the capability to bring small molecules through the clinic to commercialization. KalVista now seeks a Sr. Manager, Medical Writing which is critical to the organization's mission as it prepares to commercialize sebetralstat, a novel, oral plasma kallikrein inhibitor in Phase 3 development for the on-demand treatment of HAE attacks. We anticipate data from the Phase 3 trial in early 2024 and an NDA filing in the first half of 2024.

The Medical Writing Manager/Sr. Manager will be responsible for executing publication plans through timely development of accurate and compliant publication activities. Assisting Director, Medical Communications & Publications in engaging internal and external authors and managing vendors to deliver high-quality scientific publications for KalVista products. All journal manuscript submissions, conference abstracts and poster reviews and submissions, as well as tracking, reporting, and archiving publications will be a direct responsibility of the Publications Manager. Additionally, the role will have direct interaction with senior internal leaders, external experts, and other team members in their publication activities to ensure quality, timeliness, and compliance with publication planning and approval processes. 

Responsibilities:

• Take a leading role in the development, editing, and submission of scientific manuscripts, abstracts, posters, and presentations derived from clinical data and core scientific messages, including liaising with internal and external stakeholders on these materials
• Manage publication platforms and vendors, review to ensure their work is accurate and aligns with publication plans and processes
• Work cross-functionally to ensure core messages are aligned with other internal communication groups
• Ensure that all developed materials are reviewed and appropriately signed off; ensure that there is a maintained archive of approved materials as well as documentation of author participation and other audit records
• Be responsible for compliance with company policies and external requirements (e.g., journal policies, Good Publication Practices, ICMJE guidelines, CONSORT, etc. are needed), including working with authors, scientific contributors, external contracted medical writers/vendors, journal editorial teams, and congresses to ensure that publications are compliant, accurate, balanced, and timely
• Provide scientific, writing, and editorial support as directed/assigned

Requirements

• Advanced degree in scientific field required (e.g., PhD, PharmD)
• Minimum of 2 years of writing and/or publications experience in the pharmaceutical or affiliated industries (e.g., medical communications agency)
• Ability to interpret and synthesize complex clinical/scientific findings, statistical reports, translate findings and adapt messages for diverse audiences
• Excellent written and verbal communication skills
• Must have published in medical/scientific journals
• Experience leading and working with teams of co-authors
• Experience planning, developing, and submitting manuscripts for publication in peer-reviewed medical journals and abstracts/posters to medical congresses
• Experience developing scientific presentations for congresses, advisory boards, and/or other meetings
• Proven expertise in scientific publishing, including journal selection, increasing likelihood of first-time acceptance, navigating the journal/congress submission process and review process, etc.
• Strong and continual focus on scientific integrity and ethics and comfortable escalating and challenging digressions from company policy or values with supervision
• Good all-around knowledge of external guidance and best practices governing reporting of biomedical research (GPP, ICMJE, CONSORT, etc.)
• Excellent project management and interpersonal skills
• Ability to prioritize and deliver multiple projects simultaneously