Who We Are

Click Therapeutics, Inc. develops and commercializes software as prescription medical treatments for people with unmet medical needs. Through cognitive and neurobehavioral mechanisms, Click’s Digital Therapeutics™ enable change within individuals, and are designed to be used independently or in conjunction with biomedical treatments. The Clickometrics® adaptive data science platform continuously personalizes user experience to optimize engagement and outcomes. Following a groundbreaking clinical trial, Click’s industry-leading smoking cessation program is available nationwide through a wide variety of payers, providers, and employers. Click’s lead prescription program is entering into a fully remote execution of a multi-center, randomized, controlled, parallel-group, phase III FDA registration trial for the treatment of Major Depressive Disorder in adults.  Click also has major pipeline expansion and progression in multiple therapeutic areas.

About the Role

The Senior Manager, Medical Writer (MW) reports directly to the VP, Clinical Operations and will be responsible for the drafting, editing, and finalization of high quality study protocols, investigator brochures, regulatory communications, and other clinical science documents. The MW will be the primary responsible individual for the full life cycle of a clinical science document. The MW will interface cross-functionally with clinical operations, science, technology teams and senior leadership. The MW should have strong scientific literacy, attention to detail, and scientific literature review capabilities. The MW will establish, and improve existing, company clinical science document standards.

This is a highly visible, creative, and agile role within a rapidly growing pre-IPO company in a nascent and fast-growing space. The role is located in our trendy Tribeca HQ, includes great benefits, and is an excellent wealth-building/equity opportunity for the right individual.

Responsibilities

• Is primary author for a variety of clinical science documents, including; study protocols, investigator brochures, regulatory communications, investigator communications, internal clinical science documentation, clinical study reports, clinical science SOPs, and others.
• Produces high quality first draft content with minimal input from cross functional team. Participates in cross functional clinical science development and strategy meetings.
• Ensures accurate and efficient annotation per style guide and AMA rules.
• Drives cross functional review of documents in accordance with established timelines. Communicates review expectations and timelines to internal/external stakeholders and team members.
• Performs quality control on documents prior to finalization. Addresses QC findings with minimal oversight from stakeholders.
• Serves as primary point of contact with CRO or contract medical writers. Ensures that documents written externally conform to company standards.
• Uses clinical science documentation expertise to develop and continuously improve medical writing SOPs, templates, style guides, etc.
• Tracks and provides regular updates on all ongoing medical writing projects. Mitigates risk by preemptively identifying execution barriers, quality impacts, and timeline drift.
• Resolves execution issues, ensuring appropriate stakeholder, cross-functional, and senior management communication.
• Contribute to the development of department SOPs

Qualifications

• Bachelor's Degree required/ Advanced Degree preferred in life sciences, health care or related discipline from top-tier university
• Medical writing experience 4+ years in biotech, pharma, or CRO setting
• Experience writing and reviewing research literature is preferred
• Experience working on academic publications for peer-reviewed journals
• Working knowledge of Good Clinical Practice (GCP) and US and international regulations for clinical trials
• Advanced written, oral, and interpersonal communication skills, including proficient knowledge of medical terminology
• Ability to deliver results and execute on required activities individually, in a team setting
• Organized and detail-oriented
• Strong negotiating skills in a compact clinical team working with aggressive timelines
• Highly responsive and proactive, a team player
• Initiative, enthusiasm and a problem-solving approach to new challenges.
• Systematic and efficient coordination skills, including an ability to prioritize

Benefits

Stock options | Competitive salary with annual review | 401(k) matching | Annual performance-based cash bonus | Comprehensive medical benefits through Aetna | Flexible Spending Accounts | Life insurance and disability benefits | Open vacation policy / unlimited PTO | Generous paid parental leave | Commuter subsidies | Monthly catered lunches | Choice of Mac, Windows, or Linux equipment | Sponsored company events | Free, unlimited office snacks and beverages | Much more…

Equal Employment Opportunity

Click Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Click Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Click Therapeutics in the U.S. In certain circumstances it may be advantageous to Click Therapeutics to support the application(s) for temporary visa classification and/or sponsor applications for permanent residence so that a foreign national colleague can accept or remain in a work assignment in the U. S. For certain classes of temporary visas, the resulting work authorization may be specific to Click Therapeutics and the specific job and/or work site. Click Therapeutics may at its business discretion decide to or refrain from obtaining, maintaining and/or extending the temporary visa status and/or sponsoring a colleague for permanent residency and /or employment eligibility, considering factors such as availability of qualified U.S. workers and the colleague's long-term prospects for securing lawful permanent residence, among other reasons. Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work for Click Therapeutics in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Click Therapeutics support of a colleague's temporary visa application or sponsorship of a colleague for permanent residence be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the colleague and Click Therapeutics.