Chief Science Writer

2 weeks ago

Gurgaon, Haryana, India beBeeMedical Full time US$ 90,000 - US$ 1,20,000
Job Title

Senior Medical Content Strategist

Job Responsibilities
  • Must have min 4 years of relevant experience in medical writing.
  • Good experience in drafting, review and workflow in clinical documentation platforms.
  • Hands on experience with user Acceptance testing activities.
  • Lead the clear and accurate completion of scientific documents, ensuring complex information is presented clearly and accurately.
  • Manage content development activities associated with individual studies, coordinating these activities within and across departments with minimal supervision.
  • Complete a variety of documents, including clinical study protocols, amendments, reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, and abstracts, posters, and presentations for scientific meetings.
  • Adhere to established regulatory standards, including ICH E3 guidelines, standard operating procedures, client standards, and approved templates, authorship requirements, and style and formatting guides.
  • Coordinate quality and editorial reviews, ensuring source documentation is managed appropriately.
  • Act as a peer reviewer for the internal team to ensure document scientific content, clarity, overall consistency, and proper format.
  • Review statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency, providing feedback to further define statistical output required and document needs.
  • Interact and build good working relations with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs to produce high-quality writing deliverables.
  • Perform online clinical literature searches and comply with copyright requirements.
  • Identify and propose solutions to resolve issues, providing technical support, training, and consultation to department and other staff.
  • Mentor and lead less experienced medical writers on complex projects.
  • Develop deep expertise on key topics in the industry and regulatory requirements.
Qualifications:
  • Bachelor's degree in a relevant discipline with relevant writing experience; graduate degree preferred.
  • Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly required.
  • Experience writing relevant document types required.
  • Extensive knowledge of English grammar and ability to communicate clearly; strong familiarity with AMA Manual of Style.
Necessary Skills:
  • Strong presentation, proofreading, collaborative, and interpersonal skills.
  • Strong project and time management skills.
  • Strong proficiency in MS Office.
  • Strong understanding of medical terminology, principles of clinical research, and how to interpret and present clinical data and other complex information.

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