Source Job

• Lead or co-lead medical writing and document quality projects, managing timelines.
• Collaborate with cross-functional study teams to develop content strategies.
• Review and verify documents against source materials for accuracy and compliance.

This partner company works in pharmaceutical and biotech development, creating scientifically rigorous medical content for evidence-based healthcare decisions. It emphasizes collaboration, professional development, and an inclusive culture.

• Provide regulatory strategy and guidance across the clinical development lifecycle, including submissions to Regulatory Authorities and Ethics Committees.
• Coordinate and prepare regulatory documents such as CTA/IND, annual reports, amendments, orphan designations, and marketing applications.
• Represent Global Regulatory Affairs at project team meetings, lead submission projects, and mentor Regulatory Affairs Specialists.

Precision for Medicine is a CRO that integrates clinical trial execution with deep scientific knowledge, laboratory expertise, and advanced data sciences, focusing on Oncology and Rare Disease. They are a growing global team that values employee contributions and fosters an environment where ideas are valued and nurtured.

• Develop and maintain integrated project plans for global regulatory submissions, ensuring adherence to scope, timelines, budgets, and quality standards.
• Act as the primary regulatory timeline contact across Clinical, Nonclinical, CMC, Quality, and Commercial functions, fostering collaboration and alignment.
• Identify and mitigate project risks, prepare teams for agency meetings, and lead responses to regulatory queries from global health authorities.

Centessa Pharmaceuticals is a clinical-stage company developing orexin receptor 2 agonists for narcolepsy and other sleep-wake disorders. As a wholly owned subsidiary of Eli Lilly and Company, it shares a culture of caring and impact with over 50,000 employees.

• Serve as primary author and lead reviewer for CMC sections of late-stage and commercial regulatory submissions.
• Provide hands-on CMC regulatory expertise across global filings, health authority interactions, and post-approval activities.
• Collaborate with cross-functional teams to align regulatory strategy with scientific and compliance requirements.

The company is a biotechnology organization developing innovative cell therapies for late-stage and commercial stages. It offers a collaborative, entrepreneurial, and innovative work environment with a fast-paced, senior-level team.

• 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.

• Develops and drives regulatory strategy for FDA Pharma and IVDR initiatives.
• Represents the regulatory function on cross-functional teams and interacts with regulatory authorities.
• Coordinates regulatory submissions and ensures compliance with global requirements.

Natera is a clinical genetic testing company specializing in non-invasive cell-free DNA and liquid biopsy testing. The team consists of highly dedicated professionals from world-class institutions who care deeply for their work and each other.

• Lead Loyal's overall regulatory strategy across CMC and clinical activities, from early development through post-approval lifecycle management.
• Act as the primary liaison with global regulatory agencies and own approval submission strategy and execution.
• Build and scale a high-performing regulatory organization, establishing governance frameworks and eCTD publishing capabilities.

Loyal is a clinical stage veterinary medicine company developing longevity drugs for dogs. It is a well-funded startup led by a first gen female CEO, with a culture focused on innovation, transparency, and empathy for all life.

• Support senior leadership in strengthening the strategic presence of medical writing across therapy areas.
• Drive resource planning, performance tracking, and process simplification to improve efficiency.
• Lead transformation initiatives and contribute to long-range planning and annual operating activities.

This partner company operates a global regulatory medical writing function, supporting strategic evolution and operational excellence across therapy areas. It emphasizes collaboration among senior leadership, internal teams, contractors, and vendors within a remote work environment.

• Lead and supervise a team of regulatory specialists managing labeling approvals, drug listings, and medical device submissions.
• Oversee FDA compliance, quality investigations, and health hazard evaluations to ensure product integrity.
• Collaborate cross-functionally with Quality Assurance, Legal, and external partners to resolve complex regulatory challenges.

The partner company is a pharmaceutical and medical device organization focused on ensuring regulatory compliance and product quality. The company fosters a collaborative and inclusive work environment, emphasizing continuous improvement and professional development.

• Lead end-to-end labeling activities across the product lifecycle for pre- and post-market products.
• Guide global labeling strategy, document development, and cross-functional regulatory teams.
• Provide strategic labeling expertise to support safe and effective product use and regulatory compliance.

A global regulatory affairs organization focused on pharmaceutical product labeling. It provides a collaborative, science-driven environment with cross-functional and international exposure.

• Provide advanced scientific leadership across medical affairs deliverables, including advisory boards, congress materials, and slide decks.
• Lead client relationships and ensure clear communication while mentoring junior writers.
• Contribute to business development and strategic initiatives with scientific insights.

Avalere Health is a healthcare consultancy with Advisory, Medical, and Marketing teams ensuring every patient is identified, treated, supported, and cared for. They foster an inclusive, flexible culture with employee network groups and global collaboration hubs.

• Lead global CMC regulatory strategy for the portfolio, including Phase 3 readiness and launch planning.
• Serve as the company's lead CMC voice with FDA, EMA, and other global health authorities.
• Build, lead, and develop a high-performing CMC Regulatory team as the company scales.

Kailera Therapeutics is a biopharmaceutical company developing novel therapies for obesity and related conditions. The company has an entrepreneurial, team-oriented culture and is passionate about creating an inclusive workplace.

• Support Clinical Trial Managers with study start-up, protocol development, and Trial Master File preparation.
• Coordinate with clinical sites on documentation, training, and compliance with FDA and GCP requirements.
• Assist with tracking study payments and providing operational support across the full study lifecycle.

The company is a partner organization specializing in clinical research and development, operating through Jobgether. It offers a structured clinical operations environment with cross-functional teams and professional growth opportunities.

• Develop and maintain global labeling documents including CCDS, USPI, and regional labels.
• Manage post-approval labeling activities, artwork updates, safety variations, and regulatory submissions.
• Collaborate with cross-functional teams to ensure accurate, timely, and compliant product information.

The hiring company is a pharmaceutical organization focused on developing and maintaining labeling strategies for innovative treatments. It offers a globally connected remote work environment that values precision, collaboration, and continuous professional development.

• Serve as CMC regulatory expert, developing global submission strategies and assessing regulatory risks for development and commercial programs.
• Lead preparation and review of CMC submission content including CTD Module 2 and Module 3 sections, and support regulatory filings from IND to MAA.
• Guide CMC lifecycle management, regulatory authority interactions, and monitor emerging regulations to inform client strategies.

Opus Regulatory is a specialist consultancy providing experts in Regulatory Strategy, CMC, Labeling, and Ad Promo to biotech and pharmaceutical clients. Their team is made up of biopharmaceutical leaders and innovators focused on delivering the highest level of regulatory consulting service.

• Contribute to regulatory strategies and coordinate interactions with health authorities.
• Manage preparation and submission of INDs/CTAs, BLAs, annual reports, and safety reports.
• Collaborate with cross-functional teams to ensure GXP compliance and support regulatory inspections.

Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for autoimmune diseases. It leverages advanced T cell engineering to suppress and eliminate autoreactive immune cells, with a culture driven by scientists and industry veterans.

• Write medically accurate, compelling copy for HCP, patient, and DTC pharma campaigns.
• Translate complex clinical data into clear, on-brand messaging across digital, email, social, and more.
• Partner with creative teams to develop integrated concepts while ensuring MLR compliance and brand voice.

Real Chemistry is a global healthcare communications and marketing agency combining deep scientific expertise, human-centred creativity, and AI-driven insights. Their #LifeatRealChem culture values collaboration, excellence, and impact, with teams across US offices and remote roles.

• Lead projects from conception to completion, delivering breakthrough creative work across multi-media channels.
• Manage and mentor creative teams, ensuring design, copy, and UX ladder up to strategic insights.
• Master clinical data and competitive landscapes while strengthening client relationships and championing creativity.

Avalere Health is a healthcare advisory, medical, and marketing company united by the purpose of reaching every patient possible. With global teams and an inclusive culture, it supports flexible working and professional growth for employees.

• Develop scientific expertise in assigned therapeutic areas and support delivery for a versatile team.
• Research and develop technical materials, ensuring accuracy in content, editorial style, and references.
• Communicate with clients and key opinion leaders on content development and attend scientific meetings.

iNIZIO Medical is a medical communications company creating compelling content and engaging communities across the healthcare spectrum. With over 2,000 employees globally, we foster a culture of diversity, inclusion, and belonging.

• Prepare and publish regulatory submissions including eCTD packages for IND, CTA, and Health Authority responses.
• Maintain submission plans, follow up on document readiness, and perform document- and submission-level technical QC.
• Support Veeva RIM records, promotional submissions (Form FDA 2253), and submission-related projects.

Summit Therapeutics is a biopharmaceutical oncology company focused on improving quality of life and resolving serious unmet medical needs. Its global team is driven by core values of integrity, collaboration, and purposeful urgency, with multiple Phase 3 clinical studies in oncology.