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2-5 years
Not Disclosed
10 Oct. 15, 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

Position Overview:

We are seeking a skilled regulatory medical writer to deliver high-quality documentation for both internal and external clients. In this role, you will provide technical consultation and strategic advice on regulations and industry best practices while showcasing your subject matter and therapeutic area expertise. You will manage medical writing projects to ensure timely delivery of quality products, collaborating effectively with clients to achieve operational excellence.

Essential Duties and Responsibilities:

  • Independently research, write, and edit peri-/post-approval documents, including clinical study reports, study protocols, informed consent forms, and other regulatory submissions.
  • Support the creation of complex clinical or scientific documents, such as Investigator's Brochures (IBs) and sections of INDs, NDAs, and CTDs.
  • Plan, organize, and execute projects autonomously, developing timelines, standards, budgets, forecasts, and managing contract modifications.
  • Liaise with cross-functional teams including project management, clinical, QA, data management, biostatistics, and regulatory to ensure project alignment.
  • Identify and escalate out-of-scope activities promptly while proposing effective solutions.
  • Analyze diverse data sets to solve complex problems, demonstrating sound judgment in selecting methodologies.
  • Act as the primary contact for projects, representing the department in meetings, audits, and client interactions.
  • Build and maintain strong client relationships, leading discussions and assisting with business development efforts.

Education, Professional Skills & Experience:

  • Bachelor’s degree in a scientific discipline or equivalent; advanced degree preferred.
  • A minimum of 2-5 years of relevant experience in writing, preferably within the pharmaceutical or CRO industry.
  • Additional qualifications in medical writing (AMWA, EMWA, BELS, RAC) are advantageous.
  • Comprehensive knowledge of document development guidelines and experience in a specialty area (therapeutic, regulatory submissions, healthcare communications).
  • Proficiency in document management systems and relevant applications (e.g., Excel, Outlook).

Personal Skills & Competencies:

  • Exceptional written communication skills in English, with the ability to create well-organized, error-free documents tailored to the audience.
  • Strong analytical skills for interpreting complex data and generating actionable insights.
  • Proficient in creating and managing effective project plans, guiding team members, and monitoring progress to achieve project goals.
  • Demonstrated professional judgment in resolving inquiries, issues, and conflicts among team members and clients.