Opportunity to work as Principal Medical Writer, at Abbott- Apply before 10th March 2024

Post: Principal Medical Writer

Job Description:

Primary Job Function

• Manage the quality, accuracy, compliance with internal & external standards, and the timely production of documents.
• Act as the Point of Contact for all medical writing/publishing activities for the affiliate.
• Ensure the quality and timelines of all publications.
• Develop, implement, and manage templates & documentation formats required for standardization of regulatory & clinical documentation as per SOPs.
• Participate in the development of scientific manuscripts and abstracts reporting clinical study data, as well as slide & poster presentations.
• Coordinate and conduct interdepartmental team reviews and sign-offs of document deliverables according to guidelines/SOPs.
• Create and maintain an audit system/trails of all document changes.
• Use scientific expertise to develop high-quality, publication-ready scientific documents (manuscripts, posters, abstracts, short communications, presentations, etc.).
• Take ownership of given assignments, consulting other project team members and department representatives proactively.
• Work in accordance with Schedule Y, Good Clinical Practices, ICH guidelines, and Standard Operating Procedures.
• Perform literature searches/reviews as necessary to obtain background information for document development.
• Responsible for the review and approval of all new medical writing vendors.

Additional Responsibilities

• Manage the writing, editing, and reviewing of clinical documents, including clinical study concepts, protocol synopses, clinical study reports (CSRs), study protocols, investigator brochures, informed consent forms, clinical data summaries, and other medical documents.

Core Job Responsibilities:

• Serve as the primary medical writing representative on assigned Project teams, collaborating closely with personnel from clinical, regulatory, and Medical departments.
• Conduct medical writing activities that support the preparation of clinical documents required for product registration and generating scientific evidence for established products (i.e., Protocols, CRFs, ICFs, CSRs, and manuscripts).
• Be accountable for ensuring compliance with Local legislation, ICH-GCP guidelines, Abbott EPD, and Indian clinical research guidelines in writing for all studies.

Candidate Profile:

• MD/PhD/MBBS/M.Pharm/B.Pharm/MSc/BSc
• Minimum 8 years of medical writing work experience in clinical research in a CRO or pharmaceutical company.

Additional Information:

• Experience: 8 years
• Qualification: MD/PhD/MBBS/M.Pharm/B.Pharm/MSc/BSc
• Location: Mumbai
• Industry Type: Pharma
• Functional Area: Research & Development
• End Date: 10th March 2024
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