Our client is a late-stage biologics company focused on significantly improving outcomes for individuals with serious and rare diseases. Our innovative therapies are designed to address unmet medical needs and have shown promising results in clinical trials and real-world applications.
We are seeking an experienced and detail-oriented Senior Medical Writer/Associate Director to join our dynamic team. In this role, you will be responsible for developing high-quality, scientifically accurate, and regulatory-compliant documents for clinical trials, regulatory submissions, and medical affairs. You will interface with cross-functional groups to ensure accurate and timely completion of writing projects and collaborate with clinical researchers, regulatory professionals, and subject matter experts to produce materials that support the advancement of clinical trials, product development, and regulatory submissions.
Responsibilities:
Medical Writing Leadership:
Serve as the medical writing lead on assigned projects, working closely with cross-functional teams on project strategies.
Implement all activities related to the preparation of writing projects, coordinating review, approval, and finalization.
Facilitate review meetings, negotiate deliverables with functional areas, and propose solutions to resolve issues during the writing process.
Scientific Writing & Documentation:
Prepare and author clinical trial protocols, investigator brochures, clinical study reports, patient narratives, and regulatory submission documents (e.g., INDs, NDAs, CTDs).
Develop clear, concise, and scientifically accurate documents that communicate complex medical and scientific information to both expert and non-expert audiences.
Ensure compliance with regulatory guidelines, industry standards, and company specifications.
Collaboration & Communication:
Work closely with clinical, regulatory, and medical affairs teams to ensure the timely delivery of high-quality documents.
Engage with internal stakeholders to understand project requirements and align on expectations.
Lead or contribute to meetings and presentations, offering strategic advice on writing-related matters.
Review & Editing:
Review and edit documents prepared by junior writers, ensuring consistency, clarity, and scientific accuracy.
Project Management:
Manage multiple writing projects simultaneously, ensuring deadlines and quality standards are met.
Identify potential challenges in document preparation and proactively address them.
Research & Analysis:
Conduct in-depth literature reviews to gather relevant background information.
Interpret complex data from clinical trials, laboratory studies, and medical research to present findings clearly and accurately.
Regulatory Knowledge:
Stay up-to-date with changes in regulatory requirements, guidelines, and industry trends.
Ensure that all documents comply with the latest FDA, EMA, ICH, and other relevant regulatory requirements.
Qualifications:
BA or higher degree in life sciences, pharmacology, medicine, or a related field. A Master's or PhD is preferred.
Minimum of 10 years of experience as a medical writer, with a focus on clinical, regulatory, or scientific writing in the pharmaceutical, biotechnology, or healthcare industries.
Demonstrated experience in preparing regulatory documents and publications for submission to regulatory agencies (e.g., FDA, EMA).
Evidence of medical writing career development desirable, such as certifications from the European/American Medical Writers Association or relevant training through Drug Information Association.
Skills & Competencies:
Strong understanding of clinical trial methodology and regulatory requirements.
Excellent written and verbal communication skills.
Proficient in Microsoft Word, Excel, Adobe Acrobat, and project management tools.
Experience using document management software (e.g., SharePoint, Veeva).
High attention to detail, with the ability to critically evaluate and edit scientific content.
Ability to work independently and as part of a team, managing multiple priorities effectively.
Preferred:
Experience in writing for multiple therapeutic areas, including rare diseases and immunology.
Knowledge of medical writing software (e.g., EndNote, Adobe Acrobat).
Certification from AMWA or similar organizations, with a specialty in Editing/Writing or Pharmaceutical writing.
Advanced understanding of drug development processes, biostatistics, clinical research concepts, and scientific principles related to nonclinical development and CMC.
