Medical Content Specialist

7 days ago

Remote, India beBeeMedicalContent Full time

Job Title: Medical Content Specialist

Job Summary:

We are seeking an experienced medical content specialist to join our team. The successful candidate will be responsible for creating high-quality medical writing deliverables that present scientific information clearly and accurately.

Key Responsibilities:
  • Compiling, writing, editing, and coordinating medical writing deliverables that present scientific information clearly and accurately.
  • Working as a medical writer within and across departments with minimal or moderate supervision.
  • Completing a variety of documents that may include clinical study protocols and clinical study protocol amendments; clinical study reports; patient narratives; annual reports; investigator brochures; informed consents; annual reports; plain language summaries; periodic safety update reports; journal manuscripts; and abstracts, posters, and presentations for scientific meetings.
  • Adhering to established regulatory standards, including ICH E3 guidelines, company standard operating procedures, client standards, and approved-templates, authorship requirements, and style and formatting guides.
  • Coordinating quality and editorial reviews; ensuring source documentation is managed appropriately; leading document reviews, reviewing documents as needed, and resolving comments from clients.
  • Acting as a peer reviewer for internal teams to ensure document scientific content, clarity, overall consistency, and proper format.
  • Reviewing statistical analysis plans and table/figure/listing specifications for appropriate content and grammar, format, and consistency; providing feedback to further define statistical output required.
  • Interacting and building good working relations with clients, department heads, and peers, as necessary, to produce writing deliverables.
  • Performing online clinical literature searches and complying with copyright requirements.
  • Identifying and proposing solutions to resolve document issues, escalating as appropriate.
  • Mentoring less experienced medical writers on projects, as necessary.
  • Maintaining a strong working knowledge of drug development processes, regulatory guidelines, industry standards, and best practices.
  • Aware of budget specifications for assigned projects, working within the budgeted hours and communicating status and changes to leadership.
  • Completing required administrative tasks within specified timeframes.
Requirements:
  • Bachelor's degree in a relevant discipline with relevant writing experience; graduate degree preferred.
  • At least 2 years of relevant experience in science, technical, or medical writing.
  • Experience working in the biopharmaceutical, device, or contract research organization industry preferred.
  • Familiarity with FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly preferred.
  • Experience writing relevant document types preferred.
  • Extensive knowledge of English grammar and ability to communicate clearly; familiarity with AMA Manual of Style.
What We Offer:

This role offers the opportunity to work on a wide range of medical writing projects, develop expertise in regulatory guidelines and industry standards, and collaborate with experienced professionals in the field.

About Us:

We are a team dedicated to delivering high-quality medical writing services. Our goal is to provide accurate and clear scientific information to support decision-making in the pharmaceutical and biotechnology industries.

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