Source Job

$119,700–$186,000/yr
US

  • Leads the definition, development, and market introduction of next-generation clinical trial document authoring and analytics capabilities.
  • Operates at the intersection of clinical science, technology, and commercial strategy to translate domain knowledge into product requirements and prototypes.
  • Partners with Product Management, Engineering, and Business Development to drive cross-functional execution and commercial enablement.

Product Management Cross-functional Leadership Regulatory Affairs

20 jobs similar to Sr Director, CT Document Authoring Insights

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  • Define and execute the clinical platforms roadmap and lead end-to-end product development.
  • Oversee platform operations, PMO governance, and delivery execution across teams and vendors.
  • Partner with clinical and commercial teams to position platforms as differentiated and scalable.

Fortrea is a global contract research organization supporting the development of life-saving therapies through clinical trial services. With a large, global team, Fortrea fosters a collaborative culture focused on innovation and patient-centric delivery.

US

  • Supports clinical trial design, protocol development, and data interpretation to ensure high-quality data generation.
  • Provides medical expertise in therapeutic areas, reviews safety data, and contributes to regulatory documents.
  • Collaborates cross-functionally with clinical operations, regulatory affairs, and other teams to align clinical activities with development plans.

Oruka Therapeutics is developing novel biologics for chronic skin diseases. As a publicly traded biotechnology company with a startup culture, it focuses on offering patients greater freedom from conditions like plaque psoriasis.

Global

  • Partner with Clinical Scientists and Clinician Services leaders to design and deliver study-specific training programs.
  • Develop calibration strategies, monitor clinician performance, and implement quality improvements.
  • Lead group training, coaching, and documentation while ensuring GCP and regulatory compliance.

Clario, part of Thermo Fisher Scientific, provides endpoint data solutions for clinical trials. Its global team has supported over 30,000 clinical trials and 70% of FDA drug approvals since 2015.

$108,920–$171,160/yr
US Unlimited PTO

  • Set clinical validation standards for new features, workflows, interventions, and AI-supported experiences before and after launch.
  • Bring the clinical lens to feature assessment alongside Product, calibrating the level of clinical rigor to the actual risk of each feature.
  • Monitor and interpret clinical outcomes to identify drivers of improvement, decline, or variation, and direct program, protocol, product, workflow, or training changes in response.

Sword is building AI to heal billions and unlock humanity’s full potential, pioneering a fundamentally new approach to healthcare called AI Care. Since 2020, Sword has expanded across multiple health areas, serving over 1 million members, 2,000+ enterprise clients, and backed by $500 million from leading investors.

  • Provide clinical, scientific, and strategic expertise to drug development programs from lead compound identification to launch.
  • Lead execution of clinical development plans, including trial documents, regulatory interactions, and cross-functional alignment.
  • Establish and maintain relationships with external medical experts and represent Ipsen at investigator meetings and scientific conferences.

Ipsen is a mid-sized global biopharmaceutical company focused on transformative medicines in Oncology, Rare Disease and Neuroscience. With teams in more than 40 countries, it champions human-centric leadership and fosters a culture of collaboration, excellence and impact.

US Canada

  • Prepare and maintain Trial Master Files for internal and external studies to meet sponsor specifications.
  • Communicate with sponsors, project managers, and study contacts to ensure compliance with protocols and regulatory requirements.
  • Manage multiple priorities and ensure file structure and indexing are accurate.

Celerion is a clinical research organization that uses translational medicine to accelerate drug development. The company values integrity, trust, teamwork, and respect, and is an equal opportunity employer.

Global

  • Craft and review regulatory documents such as clinical study reports, protocols, and investigator's brochures.
  • Collaborate with a supportive team to exceed client expectations.
  • Learn the intricacies of drug development and the science behind pharmaceuticals and biologics.

Eldridge Writing is a growing firm providing top-tier medical writing services to pharmaceutical and biotechnology clients. They pride themselves on quality and mentorship of the next generation of medical writers.

Global

  • Lead author on complex regulatory and clinical documents including protocols, CSRs, IBs, and IND/NDA/BLA submissions.
  • Provide strategic input on document planning, messaging, and quality control while mentoring other writers.
  • Manage multiple projects independently, balancing timelines and client expectations in a fully remote environment.

Eldridge Writing provides top-tier medical writing services to pharmaceutical and biotechnology clients. We are a small, collaborative team that values quality and serves as a true extension of our clients’ teams.

$137,300–$242,300/yr
US

  • Lead clinical study strategy and execution for regulatory approvals and evidence initiatives.
  • Partner with stakeholders, investigators, and KOLs to design protocols and manage study progress.
  • Oversee monitoring, compliance, and data analysis while mentoring junior staff.

Intuitive is a global leader in robotic-assisted surgery and minimally invasive care, known for da Vinci and Ion systems. Its team of engineers, clinicians, and innovators works to make surgery smarter, safer, and more human.

$140,000–$165,000/yr
US

  • Serve as the connective tissue between Product, Engineering, Clinical, and go-to-market teams to drive cross-functional initiatives.
  • Own the Product Operations roadmap, defining vision, priorities, and success metrics from the ground up.
  • Champion AI-forward tools and methodologies to enhance planning, development, and research workflows.

Form Health is a virtual obesity medicine clinic delivering physician-led, evidence-based care for obesity and related cardiometabolic conditions. Founded in 2019, the company is venture-backed and mission-driven, partnering with employers and health plans to expand access to high-quality care nationwide.

  • Lead regulatory strategy for oncology drug development programs, ensuring alignment with US and global health authorities.
  • Plan and manage Clinical Trial Applications, Market Applications, and amendments with high-quality submissions.
  • Collaborate cross-functionally to integrate evolving regulations and drive process improvements.

Iovance Biotherapeutics is a global leader in developing and delivering tumor infiltrating lymphocyte (TIL) cell therapies for solid tumors, with an FDA-approved treatment for advanced melanoma. The company operates as an end-to-end cell therapy organization with U.S.-based manufacturing, serving thousands of cancer patients worldwide.

$74,825–$87,600/yr
Canada

  • Lead end-to-end management of complex proposal responses for global clients, driving strategic alignment and cross-functional collaboration.
  • Develop and refine compelling proposal content, ensuring compliance, strategic alignment, and error-free submissions.
  • Act as a trusted advisor within the proposal team, mentoring members and contributing to operational improvements and best practices.

D2L is a cloud company modernizing education and building the Future of Work. With a 25-year mission, the company employs a global team dedicated to transforming learning and fostering a collaborative, innovative culture.

Europe

  • Own WealthComply's product end-to-end: customers, requirements, roadmap, and outcomes.
  • Write detailed requirements for engineers and AI coding agents, deciding what ships and in what order.
  • Run daily standups, own release readiness, and turn customer signals into roadmap decisions.

All Cares is a small group of companies building software for private wealth and governance, including WealthComply for FATCA/CRS compliance and MinuteMaster for board governance. The team is intentionally small and autonomous, with a remote-first culture and hands-on ownership across products.

United States

  • Own the strategic scientific narrative for a lead program, building fluency in science, data, development strategy, competitive context, and patient value.
  • Shape scientific positioning and key messages in critical clinical and regulatory documents, including protocols, IBs, CSRs, briefing docs, and overviews.
  • Serve as a connective thread across Clinical Development, Regulatory Affairs, Medical Affairs, Commercial, and other functions to ensure a consistent, rigorous scientific story.

Praxis Precision Medicines is a fully integrated, clinical-stage precision neuroscience company that applies genetic insights to discover and develop therapies for rare and prevalent neurological disorders. The company offers a world-class benefits package including medical, dental, vision, 401(k) matching, stock incentives, and generous PTO, fostering a culture of trust, ownership, curiosity, and results.

$105,900–$179,400/yr
US

  • Develop Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs) per EU MDR to support CE Mark submissions.
  • Interact with cross-functional teams to define strategies for clinical documentation and regulatory submissions.
  • Conduct literature searches, critically appraise scientific data, and write clinical summaries for products and surgical procedures.

Intuitive is a global leader in robotic-assisted surgery and minimally invasive care, developing technologies like the da Vinci surgical system and Ion to transform surgery. The company is a team of engineers, clinicians, and innovators united by a purpose to make surgery smarter, safer, and more human, with challenging but deeply meaningful work.

$110,000–$130,000/yr
US

  • Lead a large, complex medical affairs and publications account while serving as a strategic partner to clients.
  • Oversee end-to-end execution of abstracts, posters, manuscripts, and related publication assets with compliance and timeline rigor.
  • Drive financial oversight, risk management, and cross-functional collaboration to deliver strategic medical affairs initiatives.

Ashfield MedComms is a global leader in the medical communications space, serving clients across medical affairs, publications, and commercial. As part of Inizio Medical, it connects a full suite of advisory, medical, and marketing services for health and life sciences companies.

France

  • Monitor and own the progress of clinical studies at investigative sites, ensuring compliance with protocols and regulations.
  • Coordinate study setup activities, including investigator identification and regulatory submissions, while mentoring junior staff.
  • Interact directly with clients, manage payments, and participate in proposal activities, with travel up to 50-60%.

Precision for Medicine is a specialized CRO that combines agility with scientific expertise to support innovative clinical development programs. They foster a collaborative environment that values quality, accountability, and professional development, with a global team of experienced professionals.

$330,000–$370,000/yr
United States Unlimited PTO

  • Build the clinical development plan and first-in-human strategy from the ground up.
  • Design the Phase 1 protocol: dose, endpoints, population, pharmacodynamic readouts, and design nuance across two therapeutic areas.
  • Shape the translational and biomarker strategy to turn a preclinical mechanism into a credible human proof-of-mechanism readout.

Enveda is a clinical-stage, AI-enabled biotech discovering medicines four times faster than the industry standard. They recently raised $311M in a Series E, are recognized as one of America's Best Startup Employers by Forbes, and a Top 100 Most Loved Workplace by Newsweek, building a rare company with a collaborative and direct culture.

UK Spain Poland Hungary Romania Serbia Slovakia

  • Serve as primary point-of-contact liaison with clients, providing outstanding customer service and participating in proposal activities and client presentations.
  • Oversee all aspects of clinical research trials, directing project managers and ensuring consistency across assigned portfolios.
  • Manage study budgets, financial health, and project plans, including risk management and quality assurance, while leading cross-functional teams.

Precision Medicine Group is a people-focused CRO that combines novel clinical trial designs, industry-leading operational and medical authorities, and advanced biomarker and data analytics solutions, with a passion for rare diseases and oncology. The company fosters a supportive and collaborative environment, promoting work-life balance and team development, with a growing team dedicated to ground-breaking cancer therapies.

Europe

  • Lead governance, harmonization, and continuous improvement of Clinical Operations processes across the organization.
  • Develop, simplify, and maintain Clinical Operations SOPs, work instructions, and process documentation.
  • Act as senior Clinical Operations SME for audits, inspections, CAPAs, and strategic initiatives.

Precision for Medicine is a global precision medicine clinical research services organization that integrates clinical operations, laboratory expertise, and data sciences. The company has a collaborative culture and supports remote work across Europe.