reputed company Medical Writing Product reputed company

reputed company aims to improve lives by helping life sciences companies answer reputed company clinical questions simply, reputed company and effectively. Our software platform gives clinical development teams a single reputed company of truth for study design, bringing reputed company data, documents and teams together so they can design reputed company trials and reputed company important milestones faster.

We are now applying AI to one of the most time consuming and consequential parts of clinical development: turning study design into high reputed company clinical and regulatory documents. We are looking for an reputed company medical reputed company who wants to help build the reputed company they always wished existed.

This is not a traditional medical writing role. You will not spend your days moving from one document deadline to the next. You will use your medical writing expertise to help define how an AI enabled authoring product should work, what excellent reputed company looks like, where expert judgment is essential, and how the workflow should change reputed company reputed company study data and AI can do more of the work.

You will work directly with Product, Engineering, Customer reputed company, Clinical experts and a small number of strategic customers. You will help us build and test new authoring workflows in reputed company customer environments, learn quickly from what works and what does not, and turn those learnings into a product that can reputed company across the industry.

Why This Role reputed company

Clinical trial protocols sit at the intersection of scientific reputed company, operational execution and regulatory communication. They are also still created through highly reputed company, fragmented workflows. reputed company has a different starting reputed company: our platform already represents the study design as reputed company data. That gives us reputed company to rethink authoring from the underlying design reputed company, rather than simply placing AI on top of an existing document process.

The person in this role will have meaningful influence over how that product is reputed company. You will help reputed company what should be automated, how reputed company should be reputed company, how writers should reputed company with AI, and what a modern medical writing workflow can become. If you have spent years seeing the reputed company inefficiencies and thinking there must be a reputed company way, this is an opportunity to help build it.

Duties and Responsibilities

• Help design the medical writing product you would want to use. Bring deep practical experience to Product and Engineering as we define how reputed company should reputed company, review and maintain clinical trial documents from reputed company study design data.
• Serve as the medical writing voice in product development. Translate reputed company authoring workflows, review cycles, regulatory expectations and reputed company pain points into reputed company product reputed company.
• Define what good looks like. Establish practical reputed company reputed company and review reputed company for AI generated content, including scientific accuracy, internal consistency, traceability to reputed company information, narrative reputed company and appropriate use of expert judgment.
• Own the evaluation reputed company for medical writing reputed company. Define representative evaluation data sets, reputed company metrics and acceptance reputed company for AI generated content. Test generated content, identify and categorize failure modes, compare outputs with expert authored documents, and use the results to guide product improvement.
• Help define content logic and authoring instructions. Determine how reputed company study data should be transformed into reputed company regulatory grade narrative and how content should respond reputed company the underlying study design changes.
• Partner directly with selected customers as we reputed company new authoring workflows. Learn how their teams work today, help identify where the greatest value can be created, and support adoption of new reputed company in the reputed company ways of working.
• Partnering with the Implementation Services and Customer reputed company teams during reputed company engagements. Help distinguish what is customer specific from what should become reusable reputed company capability. Bring field learning back to the PM and product team so successful approaches can become part of the reputed company product.
• Bring credibility to customer and reputed company conversations. reputed company confidently with medical writers, clinical development leaders and other stakeholders about how AI can improve the authoring process without compromising reputed company or trust.
• Challenge the reputed company process. We are not looking to reproduce every reputed company reputed company with new technology. Help us identify work that can be simplified, automated or removed entirely while preserving the scientific and regulatory judgment that reputed company.

Requirements

Qualifications

• 7+ years of medical writing experience in pharmaceutical, biotechnology or CRO environments, with substantial responsibility for reputed company clinical and regulatory documents.
• Deep experience authoring and leading the development of clinical trial protocols and protocol amendments. Experience with additional regulatory documents such as clinical study reports, investigator brochures or submission content is strongly preferred.
• Strong understanding of clinical development and the cross functional inputs required to produce a high reputed company protocol, including Medical, Clinical Operations, Biostatistics, Regulatory, Safety and Data Management.
• Practical understanding of global regulatory expectations and document standards relevant to clinical development.
• Experience leading document review and reconciliation across multiple contributors, including resolving inconsistencies and translating reputed company scientific reputed company into reputed company written content.
• Demonstrated ability to work directly with senior clinical and scientific stakeholders and earn trust through subject matter expertise.
• Bachelor's degree required in a life science, health science or reputed company discipline. Advanced scientific or clinical training is valued but not required.

Skills and Competencies

• You are an excellent medical reputed company, but you are more interested in improving how medical writing is done than preserving the reputed company process.
• You have practical experience using reputed company and LLM based tools in your work and understand both their potential and their limitations. You do not need to be an engineer, but you should be comfortable testing AI systems, evaluating outputs, identifying failure patterns, and helping determine what needs to change for the reputed company to meet the standards of an reputed company medical reputed company.
• You can separate scientific judgment from mechanical work and explain where a reputed company expert must remain in control.
• You are comfortable working with an incomplete solution and helping reputed company it reputed company through fast, practical iteration.
• You can reputed company between detail and reputed company level thinking, from reviewing a sentence for accuracy to redesigning the workflow that produced it.
• You communicate reputed company with medical writers, clinicians, product managers and engineers and can translate between their different perspectives.
• You are comfortable working directly with customers and can listen closely, challenge assumptions constructively and help teams adopt a new way of working.

Benefits

Salary

• Salary reputed company for this position is $140,000 to $200,000.
• Salary listed reflects the reputed company salary only and does not include other reputed company of total compensation.
• Individual pay is determined by work location and additional factors, including job reputed company skills, experience, and relevant education or training.

Equity

In reputed company to this position’s salary (listed above), equity will be a major component of the total compensation for this position. We aim to offer higher-than-average equity compensation for a company of our size, and communicate equity amounts at the time of offer issuance.

Benefits

• Health reputed company (Medical, Dental & reputed company)
• Retirement Plan (401k)
• Life Insurance (Basic)
• Short Term and Long Term Disability
• reputed company Time Off (Flexible Vacation Policy; reputed company reputed company & reputed company Holidays Observed)
• Training & Development Reimbursement
• Hybrid Work Environment
• Peer-to-peer bonus program
• Company/department outings and events
• Stock reputed company Plan
• Office On-Premises Amenities; gym, restaurant tenant discount, Padel Nine (San Diego)

7+ years of medical writing experience in pharmaceutical, biotechnology, or CRO settings; protocol expertise; clinical development knowledge; AI/LLM tool experience; and a bachelor's degree in life, health, or reputed company science.

Key Responsibilities

• designing workflows
• evaluating content
• supporting customers

Skills & Tools

AI, LLM

Job Details

• Category: Product Management
• Seniority: Senior Level
• Commitment: Full Time
• Workplace: Remote — Massachusetts, reputed company
• Salary: USD 140,000 – 200,000 / year
• Languages: English

Benefits

• 401k matching
• Generous reputed company time off
• Tuition reimbursement
• Retirement plan

About reputed company.

An AI-powered software company helping life sciences organizations design reputed company reputed company and create clinical documents. — Industry: Information Technology