Develop high-quality clinical and regulatory documents supporting global submissions
Partner with cross-functional teams to transform complex scientific data into clear narratives
Ensure compliance with regulatory requirements while managing document timelines
Acadia Pharmaceuticals is a biopharmaceutical company developing innovative therapies to address unmet medical needs in neuroscience. With a collaborative and patient-focused culture, the company is committed to advancing treatments that improve lives.
Independently plans and prepares regulatory documents and medical communications for all phases of product development.
Organizes, analyzes, interprets, and presents scientific and statistical information per ICH guidelines.
Collaborates with cross-functional internal and external document production teams.
Veristat is a global contract research organization with over 30 years of expertise accelerating life-changing therapies to patients worldwide. The company has a flexible, inclusive culture with a 70% remote workforce and 66% women-led teams.
Independently plans and prepares regulatory documents and medical communications to support all phases of product development.
Organizes, analyzes, interprets, and presents scientific and statistical information in accordance with industry guidelines (ICH, ICMJE, GPP).
Collaborates with cross-functional internal and external teams under direction of Medical Writing management.
Veristat is a global contract research organization that accelerates life-changing therapies to patients worldwide. With over 30 years of expertise, the company has supported more than 105 approved therapies and fosters a flexible, inclusive culture with 70% remote workforce and 66% women-led teams.
Lead the preparation of complex clinical and regulatory documents including Clinical Study Protocols, Clinical Study Reports, and Investigator Brochures.
Collaborate with clinical development teams and stakeholders to produce accurate, compliant, and scientifically robust documentation.
Manage document timelines, review cycles, and project deliverables while ensuring quality standards and regulatory requirements are met.
Our partner is a specialized medical writing team supporting the development of high-quality regulatory documentation for the global pharmaceutical industry. It offers a collaborative, remote environment focused on quality, precision, and scientific communication.
Develop and manage medical content for pharmaceutical, biopharma, and device clients, including SRDs, FAQs, and slide sets.
Drive document development from material gathering through MLR review, using tools like Veeva PromoMats.
Collaborate with global teams to ensure timely, high-quality, compliant deliverables that meet client needs.
EVERSANA provides next-generation commercialization services to the life sciences industry. With over 7,000 employees globally, the company serves more than 650 clients and is certified as a Great Place to Work, fostering an inclusive culture.
Critically evaluate scientific literature and produce accurate regulatory documents.
Manage writing assignments across multiple projects and ensure timely delivery.
Work directly with clients and multidisciplinary teams on regulatory submissions.
A partner company in the pharmaceutical, biotechnology, and medical device sectors is hiring a Senior Medical Writer. The company offers a fully remote environment and opportunities to work on a broad portfolio of clinical and regulatory documents.
You will lead global regulatory strategy for drug development programs, focusing on Ex-US health authorities.
You will manage and create high-quality regulatory submissions, including Clinical Trial Applications and Market Applications.
You will collaborate cross-functionally to negotiate optimal development paths and ensure compliance with evolving regulations.
Iovance Biotherapeutics is a biotechnology company focused on developing tumor infiltrating lymphocyte (TIL) therapy for cancer treatment. The company is committed to innovation in cell therapy and has a clinical-stage pipeline.
Support and contribute to global regulatory strategies to expedite development and mitigate risks.
Plan, prepare, and coordinate regulatory documents for submissions to global health authorities (INDs, BLAs, MAAs, etc.).
Collaborate with cross-functional teams and support interactions with FDA and other Health Authorities.
Immunovant, Inc. is a clinical-stage immunology company developing targeted therapies for autoimmune diseases. As a rapid-growth biotech startup, it fosters a dynamic, fast-paced, and entrepreneurial environment.
Develop high-quality, evidence-based medical content for healthcare professionals that supports clinical integrity and commercial objectives.
Translate complex scientific information into clear, compelling communications across print and digital formats.
Collaborate with cross-functional teams including medical, legal, and design to manage multiple projects and meet timelines.
Montu is Australia's largest healthtech business focusing on alternative healthcare, supporting patients, doctors, and pharmacies. Founded in 2019, Montu has been recognized as Australia's fastest-growing tech company with a driven and results-focused culture.
Lead the development of disease-state and product-specific materials and the omni-channel scientific communications strategy.
Oversee the development of standard and custom responses to unsolicited requests and create internal Medical Information resources.
Lead publication strategy and execution for clinical and nonclinical data including manuscripts, abstracts, posters, and presentations.
Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities. The company is fully remote and headquartered in Radnor, Pennsylvania.
Provide regulatory guidance throughout the clinical development lifecycle and prepare quality regulatory submissions.
Compile, coordinate, and review applications to regulatory authorities, including CTA/IND and amendments.
Represent Global Regulatory Affairs at project team and business development meetings, overseeing Regulatory Affairs Specialists.
Precision Medicine Group is a life sciences company providing clinical research, regulatory, and commercial services to biopharmaceutical clients. It fosters a collaborative, quality-focused culture and is an Equal Opportunity Employer.
Manage daily regulatory submission operations to ensure timely, compliant, and high-quality health authority submissions.
Prepare, format, and publish complex regulatory documents according to internal standards and regulatory requirements.
Perform detailed technical quality control reviews of regulatory documents and published submission sequences.
This company specializes in regulatory operations and publishing for innovative healthcare solutions. The team operates in a fast-paced life sciences environment with a collaborative and multidisciplinary approach.
Lead development of complex medical writing and publication deliverables for clinical studies.
Define document strategies and coordinate writing activities across multidisciplinary teams.
Mentor less experienced writers and enhance processes to ensure high-quality outputs.
A global life sciences and healthcare company offering integrated services across the industry. It fosters an inclusive, collaborative culture focused on employee growth, professional development, and delivery of important therapies.
Manage analytical development, QC, and stability activities at contract manufacturing sites.
Author and review CMC sections for US and ex-US regulatory filings.
Collaborate with Quality Assurance to close investigations and manage change controls.
BridgeBio is a biotech company that pioneered a 'moneyball for biotech' approach, pooling projects and early-stage research to reduce risk and develop medicines for rare diseases. They foster a culture of curiosity and experimentation with small teams of experts.
Provide technical writing support for safety, epidemiology, registry, and risk management program operations.
Develop, revise, and finalize program reports, including Knowledge, Attitudes, and Behavior (KAB) survey outcome reports.
Collaborate directly with program operations teams to understand requirements and deliver high-quality documentation.
Jobgether uses AI-powered matching to connect candidates with hiring companies for job applications. They operate as a partner company managing applications and next steps for various positions.
Develop scientific materials such as slide decks, infographics, and social media posts to support medical affairs strategy.
Translate clinical and health economic evidence into clear, compliant content for internal and external stakeholders.
Coordinate with cross-functional teams and external vendors to deliver high-quality materials on time.
Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines for hypertension and related comorbidities like chronic kidney disease and sleep apnea. It is headquartered in Radnor, Pennsylvania, operates as a fully remote company, and fosters a diverse and dynamic team culture.
Research and develop technical materials ensuring accuracy and editorial style.
Partner with clients and KOLs on content development and attend scientific meetings.
Create materials for different medical audiences in various media formats.
ApotheCom is a leader in medical communications, providing high-quality medical communications programmes. As part of Inizio, a global healthcare consulting group with over 10,000 employees, they foster a diverse and inclusive workplace.
Serve as the site manager, ensuring data entry and query resolution, and maintain high-quality data and audit readiness at clinical sites.
Monitor ongoing compliance to study protocols and site adherence to global regulatory guidelines, including safety reporting, both onsite and remotely.
Manage device accountability, inventory, distribution, and regulatory documentation to ensure compliance and audit readiness.
Penumbra is a global healthcare company focused on innovative therapies, designing, developing, manufacturing, and marketing novel products for challenging medical conditions. The company sells its products to hospitals and healthcare providers worldwide through direct sales and distributors.
Create bioanalytical reports, plans, and submission documents in support of internal projects and regulatory preclinical/clinical studies.
Extract and format data from multiple lab systems for integration into reports using Microsoft Office.
Ensure documentation complies with FDA, GxP, EMA, and other regulatory guidelines.
BioAgilytix provides best-in-class bioanalytical services to support new medicine breakthroughs. They have a team of highly experienced scientists and professionals, are growing, and are committed to being solution-oriented and deadline-driven.
Lead the development and improvement of product compliance programs, including policies, procedures, and monitoring frameworks.
Apply regulatory judgment to complex compliance issues, conduct risk assessments, and support corrective actions.
Leverage AI-enabled tools to enhance compliance documentation and analysis, while collaborating with cross-functional teams.
The company provides an AI-powered job matching platform for candidates and employers. It is a partner-driven organization that focuses on compliance solutions in healthcare, with a small to medium size, offering remote work flexibility and a culture of continuous improvement.