Medical Writer I / Medical Writer II

We work with focus, agility, and shared purpose - moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry leading innovation, With Heart.

About the Role

We are seeking Medical Writer I or II, Patient Safety to join our team in a hybrid / on-site / remote capacity. As a Medical Writer I or II, Patient Safety, you will support critical pharmacovigilance and safety activities that advance new treatments for patients and ensure regulatory compliance. This position plays a key role in developing regulatory safety documents, managing safety signals, and maintaining the highest standards of scientific accuracy and compliance. You'll collaborate with cross-functional teams, follow industry-standard processes, and contribute to safety operations from product conception through lifecycle management.

You'll join a fast-paced, growth-oriented environment focused on making a meaningful impact through developing compelling safety narratives, conducting rigorous signal detection, and ensuring regulatory excellence. With diverse teams and continuous learning opportunities, Medical Writer I or II can explore career paths and expand skills across pharmacovigilance and medical writing.

Key Responsibilities

• Prepare, compile, and lead development of scheduled and ad-hoc aggregate safety reports including Periodic Safety Update Reports (PSURs), Periodic Benefit Risk Evaluation Reports (PBRERs), Development Safety Update Reports (DSURs), and other regulatory safety documents, ensuring accuracy and timely submission across multiple regions

• Conduct independent signal detection activities by collecting and analyzing safety data from multiple sources including databases, clinical data, literature, and regulatory websites, applying both quantitative and qualitative methodologies to identify potential safety signals

• Prepare comprehensive signal assessment documents such as Drug Safety Reports (DSRs) and Signal Evaluation Reports (SERs), synthesizing data from various sources and providing clear, evidence-based conclusions

• Conduct systematic literature searches and reviews to summarize safety data, identify emerging safety trends, and support signal evaluation and epidemiology assessments

• Manage signal tracking activities, maintain comprehensive signal logs, identify and resolve data discrepancies in safety data sources, and ensure data integrity across all deliverables

• Assist in preparing and updating Risk Management Plans (RMPs) and related documents, ensuring alignment with safety data and regulatory requirements across therapeutic areas

• Manage client interactions effectively, handle routine queries independently, escalate complex issues appropriately, and deliver proactive status updates while adapting to client-specific requirements

• Maintain audit-ready documentation, ensure proper archiving of source materials, and support inspection readiness activities to ensure regulatory compliance

• For Medical Writer II positions: Mentor junior team members on technical and soft skills, provide constructive feedback, lead complex client discussions, manage multi-stakeholder document review cycles, and contribute to process improvement initiatives

You'll thrive in this role if you bring:

• Strengths in analytical thinking, scientific writing, and problem-solving to interpret complex safety data and draw meaningful conclusions

• Experience working in pharmacovigilance, healthcare, or a regulated environment with understanding of global regulatory requirements

• The ability to collaborate across teams and communicate clearly with both internal stakeholders and external clients

• A patient-focused mindset, strong attention to detail, and commitment to producing high-quality, compliant deliverables

• Comfort working with medical writing tools, MS Office applications, and pharmacovigilance databases and coding dictionaries (MedDRA, WHO-DD)

Required Qualifications

• University degree in Life Sciences, Health, or Biomedical Sciences (such as Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, Dentistry, or Physiotherapy) or equivalent combination of training and work experience

• 2+ years of experience in pharmacovigilance, medical writing, or related field (Medical Writer I); 4+ years of experience (Medical Writer II)

• Solid understanding of global pharmacovigilance regulations, medical terminology, and safety-related concepts

• Proficiency in medical writing tools and MS Office applications with familiarity in pharmacovigilance databases and coding dictionaries

• Strong communication, organization, and problem-solving skills with excellent time management and ability to prioritize multiple concurrent projects

Preferred Qualifications

• Prior experience in pharmacovigilance or related safety assessment fields

• Clinical exposure in hospital-based environments or direct clinical research experience

• Expertise in specific therapeutic areas or product types

• Familiarity with pharmacovigilance systems and regulatory submission processes across multiple regions

We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.

If this job doesn't sound like the next step in your career, but perhaps you know of someone who'd be a perfect fit, send them the link to apply!