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Safety Writer

2+ years
Not Disclosed
10 Nov. 6, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Opportunity: Medical Writer at Fortrea

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With operations in over 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

We are seeking a Medical Writer to join our dynamic team. In this role, you will take ownership of writing various safety and regulatory documents, ensuring high-quality deliverables in compliance with global regulatory requirements. You will work closely with internal teams, clients, and stakeholders to gather inputs and develop documents for regulatory submissions, safety reports, and signal analysis.

Key Responsibilities:

  • Report Planning & Strategy: Lead kick-off meetings, roundtable discussions, and data collection for report planning and strategy development.
  • Safety Report Writing: Author and review safety reports for global regulatory submissions, including Annual Reports (IND and other), Periodic Safety Update Reports (PSUR), Risk Management Plans, and more.
  • Quality Review: Perform quality checks of safety reports written by junior or associate medical writers.
  • Ad-hoc Reports: Contribute to ad hoc reports, including benefit-risk evaluation reports, safety issue analysis reports, and supporting documents for label updates.
  • Regulatory Submissions: Write Common Technical Document (CTD) Summaries, Clinical Summaries, Non-Clinical Overviews, and other regulatory documents as assigned.
  • Medical Information: Author responses to medical inquiries from healthcare professionals (HCPs).
  • Signal Detection: Write and contribute to signal detection reports and safety issue analysis reports.
  • Narrative Writing: Write subject narratives for adverse drug reactions (ADRs) and serious adverse events (SAEs).
  • Collaboration & Coordination: Work closely with internal teams and clients to gather inputs, ensure accuracy, and facilitate smooth project execution.
  • Labeling: Contribute to creating and updating regulatory labels such as Core Data Sheets, USPI, SPCs, and Med Guides.
  • Literature Searches & Abstracts: Conduct literature searches for reports, review articles selected by junior writers, and write literature abstracts/summaries.
  • Process Improvement: Implement and promote the use of efficient and consistent processes to meet timelines and deliverables.
  • Compliance: Ensure compliance with all regulatory requirements in the preparation of documents.
  • Customer Service: Maintain a high level of customer service and foster strong client relationships.
  • Other Duties: Perform additional tasks as assigned, following relevant training and project requirements.

Required Qualifications:

  • Proven experience as a Medical Writer in the pharmaceutical or CRO industry.
  • Strong understanding of regulatory requirements, safety reporting, and regulatory submissions.
  • Excellent writing and communication skills, with attention to detail.
  • Ability to work collaboratively with cross-functional teams and external stakeholders.
  • Familiarity with pharmacovigilance, signal detection, and adverse event reporting.
  • Experience with Common Technical Documents (CTD) and safety-related regulatory documents.
  • Ability to manage multiple tasks and meet deadlines.
  • Bachelor’s or Master’s Degree in Life Sciences, Medical Writing, or a related field.

Location: [Insert Location]

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.

Fortrea is proud to be an Equal Opportunity Employer. As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual, without discrimination on the basis of race, religion, gender, disability, veteran status, sexual orientation, gender identity, or any other legally protected characteristic.