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Key Responsibilities and Required Skills for Medical Writing Associate

💰 $65,000 - $85,000

Medical WritingPharmaceuticalBiotechnologyClinical ResearchScientific Communications

🎯 Role Definition

Are you a talented scientist with a passion for clear, precise communication and a desire to make a tangible impact on medicine? We are actively searching for a highly motivated and detail-oriented Medical Writing Associate to join our dynamic and growing team.

In this foundational role, you will be at the heart of our clinical development process. You'll work alongside experienced professionals to transform complex clinical trial data and scientific information into a wide range of high-quality, accurate, and regulatory-compliant documents. This is a remarkable opportunity to develop your skills, gain invaluable industry experience, and build a rewarding career in a field that bridges science and communication, ultimately contributing to the advancement of life-changing therapies.

📈 Career Progression

Typical Career Path

Entry Point From:

  • Recent PhD, PharmD, or MD graduates with a strong research and publication background.
  • Postdoctoral researchers seeking a transition from academia to industry.
  • Clinical Research Coordinators or Associates with strong writing skills.
  • Individuals with a Master's or Bachelor's degree in a life science and demonstrable writing talent.

Advancement To:

  • Medical Writer
  • Senior Medical Writer
  • Principal Medical Writer / Medical Writing Manager

Lateral Moves:

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

Core Responsibilities

Primary Functions

  • Author, edit, and coordinate the development of high-quality clinical and regulatory documents, including clinical study reports (CSRs), study protocols and amendments, and investigator's brochures (IBs).
  • Assist senior writers in the preparation of complex regulatory submission documents for health authorities (e.g., FDA, EMA), such as Clinical Summaries of Efficacy and Safety for New Drug Applications (NDAs) and Marketing Authorization Applications (MAAs).
  • Prepare and format a variety of documents according to company style guides, templates, and international regulatory guidelines like ICH-GCP.
  • Perform rigorous quality control (QC) reviews, fact-checking, and proofreading of documents prepared by peers and senior staff to ensure scientific accuracy, data integrity, and consistency.
  • Collaborate effectively with cross-functional teams, including representatives from Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, and Medical Affairs, to ensure documents are comprehensive and accurate.
  • Participate in project team meetings to provide updates on document status and to understand study-related concepts and results.
  • Develop and manage timelines for document creation, review, and finalization, ensuring all deliverables are completed on schedule.
  • Conduct targeted literature searches and synthesize complex scientific and medical information to provide background and support for clinical documents.
  • Assist in the creation of scientific communications, such as abstracts, posters, and slide decks for presentation at scientific conferences and congresses.
  • Support the development of manuscripts for publication in peer-reviewed medical journals, working closely with authors and senior writers.
  • Create and maintain document-specific style sheets and reference libraries to ensure consistency across a program.
  • Learn and apply a working knowledge of the therapeutic areas, relevant drug development processes, and applicable regulatory guidelines.
  • Prepare patient-facing materials, such as informed consent forms (ICFs) and clinical trial result summaries for lay audiences, ensuring clarity and compliance.
  • Manage the routing of documents through electronic document management systems (EDMS) for review and approval cycles.
  • Address and adjudicate comments from internal and external reviewers, facilitating consensus and ensuring the scientific integrity of the document is maintained.
  • Support the writing and updating of Standard Operating Procedures (SOPs) and departmental work instructions related to medical writing processes.

Secondary Functions

  • Assist in the preparation of responses to inquiries from regulatory agencies regarding clinical and safety data.
  • Contribute to the organization's data transparency initiatives by supporting the creation of public disclosure summaries.
  • Collaborate with medical information teams to help develop standard response letters and other medical information materials.
  • Participate in departmental process improvement initiatives to enhance efficiency and quality.
  • Support ad-hoc data requests and exploratory data analysis to inform document strategy.
  • Contribute to the organization's data strategy and roadmap by providing a medical writing perspective.
  • Collaborate with business units to translate data needs into engineering requirements.
  • Participate in sprint planning and agile ceremonies within the data engineering team.

Required Skills & Competencies

Hard Skills (Technical)

  • Scientific Knowledge: Strong foundational understanding of biomedical sciences, pharmacology, and the clinical drug development process.
  • Regulatory Acumen: Familiarity with key regulatory guidelines and standards, particularly ICH-GCP, ICH E3 (CSRs), and ICH E6 (GCP).
  • Technical Proficiency: High proficiency in Microsoft Office Suite (especially Word, PowerPoint, and Excel) and experience with referencing software (e.g., EndNote, Zotero).
  • Data Interpretation: Ability to accurately interpret and summarize complex scientific and statistical data from tables, figures, and listings.
  • Literature Research: Skilled in using databases like PubMed, Embase, and other scientific resources to conduct thorough literature searches.
  • Document Management: Experience with or ability to quickly learn electronic document management systems (EDMS) and collaborative platforms.

Soft Skills

  • Exceptional Writing Ability: Impeccable command of the English language with the ability to write clearly, concisely, and accurately for a variety of scientific and regulatory audiences.
  • Meticulous Attention to Detail: A commitment to accuracy and quality, with a keen eye for spotting errors in grammar, spelling, data, and formatting.
  • Project & Time Management: Excellent organizational skills with the ability to manage multiple projects simultaneously, prioritize tasks, and meet tight deadlines.
  • Collaborative Team Player: Strong interpersonal skills to work effectively within cross-functional teams and build positive working relationships.
  • Adaptability & Receptiveness to Feedback: Ability to adapt to changing priorities and gracefully accept and incorporate constructive feedback from reviewers.

Education & Experience

Educational Background

Minimum Education:

  • A Bachelor's degree in a relevant life sciences field (e.g., Biology, Chemistry, Pharmacy, Biochemistry).

Preferred Education:

  • An advanced degree (PhD, PharmD, MD) is highly preferred, as it provides a strong foundation in research, data analysis, and scientific writing.

Relevant Fields of Study:

  • Pharmacy / Pharmacology
  • Biomedical Sciences
  • Molecular Biology / Genetics
  • Public Health

Experience Requirements

Typical Experience Range:

  • 0-2 years of relevant experience. This is an entry-level position ideal for recent graduates or those transitioning from an academic or clinical setting.

Preferred:

  • Experience in academic scientific writing, such as authoring dissertations, theses, or peer-reviewed publications.
  • Some exposure to the clinical research environment, whether through internships, postdoctoral research in a clinical area, or previous roles like a Clinical Research Coordinator.
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