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.
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.
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.
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.
Lead content development for multiple projects, ensuring high quality and adherence to regulatory guidelines.
Collaborate with internal teams and external stakeholders to develop strategic medical communications.
Supervise medical writers and contribute to new business proposals and pitch meetings.
PRECISION AQ is a top payer marketing agency that supports global pharmaceutical and life sciences clients in achieving commercial excellence. We are a specialized agency with a focus on improving market access, fostering a collaborative and detail-oriented culture.
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.
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.
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.
Serve as a key scientific resource providing accurate and timely medical information in response to unsolicited inquiries from healthcare professionals and patients.
Manage Medical Information operations, including system oversight, vendor coordination, and process optimization.
Collaborate cross-functionally with Medical Affairs, Pharmacovigilance, Regulatory, and Commercial teams to ensure compliant dissemination of medical information.
Cogent Biosciences is a publicly traded biotechnology company developing novel precision therapies for patients with unmet medical needs. We foster a collaborative environment with a focus on teamwork and innovation.
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.
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.