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Key Responsibilities and Required Skills for a Scientific Writer

💰 $90,000 - $145,000

ScienceWritingResearchPharmaceuticalsBiotechnologyMedical Affairs

🎯 Role Definition

Are you passionate about bridging the gap between complex scientific discovery and clear, impactful communication? This role requires a dedicated and detail-oriented Scientific Writer to join our innovative team. In this pivotal role, you will be responsible for crafting a wide array of high-quality scientific and clinical documents that are essential for regulatory submissions, scientific publications, and internal communications. You will collaborate with cross-functional teams of leading experts in clinical development, biostatistics, and regulatory affairs to ensure that our scientific narrative is accurate, consistent, and compelling. If you have a talent for transforming complex data into clear, concise, and regulation-compliant content, we invite you to apply and become a key voice in our mission to advance science and medicine.

📈 Career Progression

Typical Career Path

Entry Point From:

  • Postdoctoral Researcher
  • Research Scientist
  • Associate Medical Writer
  • Clinical Research Associate

Advancement To:

  • Senior Scientific Writer / Principal Medical Writer
  • Manager, Scientific Communications
  • Associate Director, Medical Writing

Lateral Moves:

  • Medical Science Liaison (MSL)
  • Regulatory Affairs Specialist
  • Clinical Trial Disclosure Specialist

Core Responsibilities

Primary Functions

  • Author, edit, and manage the development of high-quality Clinical Study Reports (CSRs) in accordance with ICH E3 guidelines, ensuring scientific accuracy and consistency with study data.
  • Develop, write, and edit a wide range of clinical and regulatory documents, including clinical study protocols, investigator's brochures (IBs), and informed consent forms (ICFs).
  • Prepare and author key modules for regulatory submissions, such as the Common Technical Document (CTD) summaries of clinical efficacy and safety (Modules 2.7 and 2.5).
  • Author and manage the submission of manuscripts for publication in high-impact, peer-reviewed scientific journals, ensuring adherence to journal-specific guidelines and ICMJE recommendations.
  • Create compelling scientific content for medical and scientific conferences, including abstracts, poster presentations, and slide decks for oral presentations.
  • Conduct comprehensive literature searches and critically evaluate scientific literature to provide background information and support for clinical and regulatory documents.
  • Collaborate closely with cross-functional teams, including clinical operations, biostatistics, data management, regulatory affairs, and pharmacovigilance, to ensure document content is accurate and complete.
  • Lead and manage document review cycles, effectively incorporating and reconciling feedback from multiple internal and external stakeholders while maintaining project timelines.
  • Ensure all documents are "submission-ready" by performing rigorous quality control (QC) checks for scientific accuracy, clarity, grammar, and consistency.
  • Interpret and present complex clinical trial data and statistical analyses in a clear and concise manner for a variety of audiences.
  • Develop and maintain document templates, style guides, and standard operating procedures (SOPs) to ensure consistency and quality across all scientific communications.
  • Prepare clear and concise briefing documents and responses to inquiries from regulatory agencies (e.g., FDA, EMA).
  • Drive the development of scientific publication plans in collaboration with medical affairs and clinical development teams to strategically disseminate research findings.
  • Author needs assessments, white papers, and other supporting scientific materials for medical education initiatives.
  • Participate in clinical project team meetings to stay informed of study progress and contribute to strategic discussions regarding data presentation and interpretation.

Secondary Functions

  • Support the development of internal training materials and presentations to educate team members on new data or scientific concepts.
  • Assist in the creation of patient-facing materials and plain-language summaries of clinical trial results to enhance transparency and patient engagement.
  • Provide writing and editing support for ad-hoc requests from various departments, including marketing and business development.
  • Mentor junior writers or team members, providing guidance on writing best practices, regulatory requirements, and project management.
  • Stay abreast of the latest industry trends, regulatory guidelines (ICH, GCP), and best practices in scientific and medical writing.
  • Contribute to the organization's data disclosure and transparency initiatives, including the preparation of materials for public registries like ClinicalTrials.gov.
  • Collaborate with medical illustrators or graphic designers to create scientifically accurate figures, charts, and graphics for publications and presentations.
  • Participate in sprint planning and agile ceremonies if working within a team that utilizes agile methodologies for project management.

Required Skills & Competencies

Hard Skills (Technical)

  • Regulatory Knowledge: Expert understanding of ICH, GCP, and other global regulatory guidelines (e.g., FDA, EMA) governing clinical trial conduct and reporting.
  • Document Expertise: Proven experience in authoring key clinical and regulatory documents, particularly CSRs, IBs, and clinical study protocols.
  • Scientific Interpretation: Exceptional ability to interpret and synthesize complex clinical and non-clinical data from various sources into a coherent scientific narrative.
  • Reference Management: Advanced proficiency with reference management software such as EndNote, Zotero, or Mendeley.
  • Software Proficiency: Mastery of Microsoft Office Suite (Word, PowerPoint, Excel), including the use of templates, styles, and advanced formatting functions.
  • AMA Style: Deep familiarity with the AMA Manual of Style and other relevant scientific style guides.
  • EDMS Experience: Experience working with electronic document management systems (EDMS) and submission platforms (e.g., Veeva Vault, SharePoint).

Soft Skills

  • Attention to Detail: Unparalleled attention to detail, with a commitment to scientific accuracy, data integrity, and grammatical precision.
  • Project Management: Strong organizational and project management skills, with the ability to manage multiple complex projects simultaneously and meet tight deadlines.
  • Communication: Outstanding written and verbal communication skills, capable of articulating complex ideas clearly and effectively to diverse audiences.
  • Collaboration: Excellent interpersonal skills and a proven ability to work effectively and build consensus within cross-functional teams.
  • Critical Thinking: Proactive problem-solving and critical thinking abilities to navigate scientific and regulatory challenges.
  • Adaptability: High level of adaptability and flexibility to manage changing priorities and navigate ambiguity in a fast-paced R&D environment.

Education & Experience

Educational Background

Minimum Education:

  • Master's degree (MSc, MPH) in a life science or health-related field.

Preferred Education:

  • Doctoral degree (PhD, PharmD, MD) in a relevant scientific or medical discipline.

Relevant Fields of Study:

  • Pharmacology
  • Immunology
  • Biology / Molecular Biology
  • Biochemistry
  • Neuroscience
  • Oncology

Experience Requirements

Typical Experience Range:

  • 3-7 years of direct scientific or medical writing experience within a pharmaceutical company, biotechnology firm, or contract research organization (CRO).

Preferred:

  • A strong portfolio demonstrating direct authorship of key regulatory documents (CSRs, IBs, CTD modules) and a record of peer-reviewed publications. Experience in therapeutic areas such as oncology, immunology, or rare diseases is highly desirable.
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