FSP Medical Writer (Thermofisher)

Roles and Responsibilities

Job Title: FSP Medical Writer

Summarized Purpose:

We are excited to be expanding our Medical Writing FSP Team in India. We are looking for a MW to be dedicated to a client in the FSP space; experience in Structured Content Authoring systems and automation to support delivery would be preferred. We are seeking a talented and experienced Medical Writer to join our team. The Medical Writer will be responsible for developing high-quality clinical and regulatory documents, ensuring they meet all regulatory requirements and company standards.

Key Responsibilities:

• Write and edit clinical and regulatory documents, including clinical study reports, protocols, investigator brochures, and regulatory submissions.

• Collaborate with cross-functional teams to gather necessary information and ensure the accuracy and completeness of documents.

• Ensure documents align with regulatory guidelines, company standards, and industry best practices.

• Provide input on document content, structure, and presentation.

• Review and provide feedback on documents prepared by other team members.

• Manage timelines and deliverables for assigned projects.

• Stay current with industry trends, guidelines, and regulatory requirements.

Education and Experience:

• Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification required; Advanced degree preferred.

• 2+ years regulatory writing experience.

• Experience working in the pharmaceutical/CRO industry required.

• Safety writing experience advantageous (e.g. DSUR)

• Experience working on structured content management system and AI-driven content creation, and familiarity with Natural Language Generation preferred.

Knowledge, Skills, and Abilities:

• Excellent organizational and program management skills

• Proven leadership skills to manage and mentor a team of medical writers.

• Extensive knowledge of regulatory guidelines and drug development processes

• Strong interpersonal and communication skills to build and maintain effective working relationships with colleagues and stakeholders

• Understanding of quality control processes to ensure compliance with regulatory requirements and internal standards

• Self-motivated and adaptable

• Excellent judgment; high degree of independence in decision making and problem solving