Source Job

• 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 development of high-quality clinical study documents including protocols, IBs, ICF, DSURs, CSRs, and patient narratives.
• Ensure smooth document management from template to final approval in collaboration with sponsors and internal teams.
• Independently formulate key messages from clinical data and author complex content with impeccable attention to detail.

Precision Medicine Group is a precision medicine company that provides clinical, scientific, and operational services to support drug development. They are an Equal Opportunity Employer with a global team and a focus on innovation and quality.

• 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.

• 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.

• Provide strategic regulatory input and manage European Clinical Trial Applications (CTA) and amendments.
• Serve as key regulatory liaison for multi-continental oncology projects, collaborating with cross-functional teams.
• Maintain expertise in GCP, EU regulations, and support business development activities.

Theradex Oncology is a full-service CRO specializing in early and late-phase oncology trials globally. Founded in 1982 with over 40 years of experience, the company has managed more than 250 trials and partners with the National Cancer Institute, maintaining a focused culture on cancer drug development.

• Manage regulatory activities for complex submissions across EU, GCC, and Australian markets.
• Conduct regulatory research, gap analyses, and prepare submission components.
• Provide regulatory expertise within multidisciplinary project teams and support business development.

The company provides regulatory consulting services for healthcare products, focusing on global markets. It fosters a collaborative, inclusive culture with opportunities for career development and meaningful impact.

• 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.

• Creates and maintains project timelines in MS Project or similar systems, ensuring accurate updates and distribution to team members.
• Coordinates internal and external meetings, prepares agendas, takes minutes, and files documentation in the Trial Master File.
• Manages study-specific training, system access, and supplies, while supporting team communications and vendor coordination.

Precision for Medicine is a Clinical Research Organization specializing in precision medicine, combining novel trial designs, operational expertise, and advanced biomarker analytics to advance oncology and rare disease treatments. The company fosters a collaborative, detail-oriented culture with a focus on professional growth and teamwork.

• Lead the strategy and evolution of next-generation document experiences within a growing SaaS environment.
• Define and execute long-term product strategy for modern document systems and AI-powered workflows.
• Partner with design, engineering, and AI teams to deliver scalable solutions and measurable customer impact.

Jobgether is an AI-powered job matching platform that connects candidates with hiring companies through an objective shortlisting process. It operates as a remote-first organization with teams across Ukraine, Poland, and Portugal, fostering a collaborative and supportive culture.

• 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.

• Serving as medical point person on assigned accounts
• Developing, writing and translating complex scientific data to a broad audience
• Ensuring project quality and outcomes by demonstrating in-depth technical expertise

PRECISION AQ is a top payer marketing agency supporting global pharmaceutical and life sciences clients. The company offers training, mentorship, and a cross-functional project team environment.

• Create high-quality medical affairs deliverables translating complex scientific data into clear, accurate content.
• Collaborate with colleagues, clients, and external experts to shape audience-tailored materials aligned with client objectives.
• Take ownership of projects from brief to delivery, ensuring scientific accuracy and engaging content.

Avalere Health is a healthcare agency focused on ensuring every patient is identified, treated, supported, and cared for. With major hubs in the US and UK, they emphasize inclusive culture, flexible work, and professional growth, supporting employee networks and family planning.

• Provide study oversight as primary liaison between CRAs, internal staff, site staff, client personnel, and external vendors.
• Ensure clinical monitoring activities comply with SOPs, regulations, GCP, KPIs, and study-specific requirements.
• Develop and manage clinical plans and guidelines, including the clinical monitoring plan and study timelines.

ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) that has been a trusted partner in clinical research since 1996, supporting research behind innovative treatments in pharmaceutical, biotech, and medical device industries. They foster a collaborative community where team members feel valued, supported, and empowered to make a meaningful impact on global health.

• Provide operational leadership and oversight for assigned FSP projects, managing regional trials or supporting complex global trials.
• Serve as the primary operational point of contact for clients, coordinating cross-functional activities and monitoring project risks, resource constraints, and quality trends.
• Contribute to financial oversight, meeting facilitation, and team onboarding, training, and mentoring.

Precision Medicine Group is a clinical research organization (CRO) focused on supporting clients researching ground-breaking cancer therapies. The company fosters a supportive, collaborative environment that promotes work-life balance and team development.

• Oversee clinical site management and ensure compliance with protocols, regulations, and quality standards.
• Serve as primary contact for study sites, conducting monitoring visits from pre-study through close-out.
• Collaborate with cross-functional teams to support data review, regulatory submissions, and site performance.

Our partner is a global clinical research organization managing monitoring activities across Phase I–IV trials and Real World Evidence studies. It offers a collaborative, fully remote environment focused on improving patient outcomes with professional growth opportunities.

• 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.

• Provide therapeutic and operational leadership throughout the clinical program and project delivery lifecycle.
• Collaborate with cross-functional teams to develop effective delivery strategies and resolve operational challenges.
• Ensure clinical projects within the assigned franchise are appropriately resourced and aligned with operational goals.

Our partner is a global clinical research organization dedicated to advancing healthcare innovation and improving patient outcomes through high-quality clinical trials. They offer a collaborative and inclusive environment with experienced professionals across global therapeutic and operational teams, focusing on professional growth and meaningful impact.