Senior/Principal Medical Writer

📋 Description

• Overseeing the creation, evaluation, and refinement of clinical study documents, which encompass clinical study protocols, clinical study reports (CSRs), investigator brochures (IBs), and regulatory submissions.

• Working in close collaboration with cross-functional teams, such as clinical research, biostatistics, regulatory affairs, and medical affairs.

• Engaging in the planning and implementation of clinical development programs, offering strategic insights and scientific knowledge.

• Assisting in the formulation of publication plans, abstracts, posters, and manuscripts.

• Guiding and mentoring junior medical writers by sharing best practices, writing techniques, and scientific principles.

⛳️ Requirements

• An advanced degree in Life Sciences, Pharmacy, Medicine, or a related discipline.

• A minimum of 4-7 years of experience in medical writing within the pharmaceutical, biotechnology, or contract research organization (CRO) sectors.

• Expertise in interpreting and summarizing intricate clinical trial data, scientific research outcomes, and statistical analyses.

• Exceptional writing, editing, and proofreading abilities.

• In-depth knowledge of regulatory requirements (e.g., ICH-GCP, FDA, EMA) that govern the preparation and submission of clinical documents and publications.

• Proven capability to function efficiently in a dynamic, deadline-oriented environment, managing multiple projects concurrently and prioritizing tasks based on project timelines and deliverables.

• Outstanding interpersonal and communication skills.

• Capacity to collaborate effectively with cross-functional teams, foster relationships with key stakeholders, and influence decision-making processes.

🏝️ Benefits

• Various annual leave entitlements.

• A range of health insurance offerings tailored to meet the needs of you and your family.

• Competitive retirement planning options to enhance savings and help you plan confidently for the future.

• Global Employee Assistance Programme, TELUS Health, providing 24-hour access to an extensive network of over 80,000 independent specialized professionals dedicated to supporting your and your family’s well-being.

• Life assurance.

• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, and more.