Lead the planning, authoring, and delivery of regulatory documents for global development programs, health authority interactions, and marketing applications.
Develop strategic document plans and author complex submissions such as INDs, CTAs, IBs, CSRs, and briefing packages while ensuring ICH/GCP compliance.
Coordinate cross-functional teams, manage external vendors, mentor junior writers, and drive process improvements to maintain submission readiness.
The company is a biopharmaceutical organization focused on developing innovative therapies for patients with significant unmet medical needs. It operates as a remote, cross-functional team with a culture emphasizing regulatory excellence, collaboration, and career development.
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.
Oversee the development of technically accurate, high-quality deliverables for Publications/Medical Affairs accounts.
Serve as a strategic partner to clients, ensuring projects and deliverables are on time and within budget.
Direct the editorial component of projects and lead a team of medical writers, ensuring accuracy and quality of all written material.
Lumanity is dedicated to improving patient health by accelerating and optimizing access to medical advances, partnering with life sciences companies to generate evidence and translate science into compelling product narratives. The company operates globally across areas such as Asset Optimization and Commercialization, Value Access and Outcomes, and Medical Strategy and Communications, fostering a collaborative culture focused on medical and commercial success.
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 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.
Develop high-quality, medically accurate promotional medical content for assigned accounts across print and digital formats.
Conduct literature reviews and develop annotations to support promotional claims in medical education and marketing resources.
Collaborate with internal teams and clients, attend medical/legal/regulatory reviews, and mentor junior staff.
Precision AQ is a top payer marketing agency supporting global pharmaceutical and life sciences clients in achieving commercial excellence. It specializes in demonstrating the economic, clinical, and societal value of medical treatments, with a collaborative, detail-oriented team culture.
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.
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 strategic medical communication recommendations and scientific content development for assigned accounts.
Oversee creation of manuscripts, posters, abstracts, and other publication deliverables across therapeutic areas.
Supervise Associate Scientific Directors and collaborate with in-house or freelance staff on research, writing, and data-checking tasks.
Lockwood collaborates with clients in the pharmaceutical, biotech, and medical device industries to identify effective, holistic, science-based strategies through medical communications. Over a third of our staff hold advanced scientific or medical degrees, and most work from where they live, fostering a flexible, talent-focused culture.
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.
Oversee operational preparation and execution of regulatory submissions, ensuring technical compliance and timely delivery.
Manage routine submissions like INDs, CTAs, and health authority responses, while supporting complex filings and maintaining submission plans.
Compile, publish, and validate eCTD packages, coordinate submission delivery, and maintain accurate records in Veeva RIM.
A partner company of Jobgether, a pharmaceutical and biotechnology organization focused on developing innovative oncology therapies. The company values regulatory precision and operational efficiency across global programs, with a remote-first culture.
Lead development and execution of Vera's publication and scientific congress strategy, ensuring clinical data are communicated accurately and consistently.
Partner cross-functionally with Clinical Development, Biostatistics, Medical Affairs, and Commercial to build integrated publication and congress plans.
Manage publications end-to-end, including vendor oversight, author review, and compliance with GPP, ICMJE, and company policies.
Vera Therapeutics is a commercial-stage biotechnology company focused on transforming medicine for autoimmune diseases, starting with the kidney. The company values empathy, ownership, clarity, and urgency, and is building a collaborative team to advance rigorous science.
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 medical direction and oversight for clinical trials, including safety monitoring and medical data review.
Partner with GCO to build client relationships and support proposals, feasibility, and business development.
Serve as drug development SME, contributing to protocols, training, and medical strategy across studies.
Fortrea is a global contract research organization providing clinical development and trial management services to pharma/biotech. It fosters a collaborative, family-like culture focused on advancing life-saving therapies.
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.
Lead U.S. and global regulatory strategies for oncology biologic development programs.
Prepare and manage Clinical Trial Applications, Marketing Applications, and regulatory amendments.
Collaborate with cross-functional teams to align regulatory plans and manage program risks.
A partner company is seeking a strategic regulatory affairs leader to support innovative oncology biologic and cell/gene therapy development programs. The company offers a fully remote environment with global regulatory exposure and cross-functional collaboration.
Serve as primary medical and scientific expert for clinical trial protocols and Expanded Access Programs.
Monitor trials to ensure participant safety, data accuracy, and protocol compliance.
Lead protocol development, investigator training, and cross-functional collaboration.
WEP Clinical partners with biopharmaceutical sponsors to deliver clinical trials, expanded access programs, and market access solutions. With 15+ years of experience across 150+ countries, they offer operational scale and a personalised culture.
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.
Lead clinical research project planning, execution, and delivery, ensuring regulatory compliance and quality.
Coordinate cross-functional teams and manage timelines, budgets, and study documentation.
Serve as the primary sponsor and client contact, providing regular project updates and resolving issues.
Alimentiv is a global CRO advancing therapies for gastrointestinal diseases, with deep expertise in IBD drug development. With about 700 employees across multiple countries, it is a private, profit-with-purpose company focused on scientific research and its people.