Medical Writer

Location

Bangalore | India

Job description

Medical Writer

Domnic Lewis has been mandated to hire Medical Writer for Bangalore location

Job Overview:

Are you motivated by challenges and thrive in dynamic environments Do you excel in close collaboration with stakeholders and value strategic alignment If continuous improvement is one of your career objectives, then we have the perfect opportunity for you. Join our growing team and contribute to an international environment.

About the Department:

The Clinical Reporting unit at GBS has experienced rapid growth since its establishment in 2011, becoming an integral part of the Global Clinical Reporting community. Our team comprises skilled Medical Writers, Disclosure Medical Writers, Publishers, and Document Controllers with advanced degrees in life sciences, pharmacology, medicine, and related fields. With an average of 7-8 years of experience in writing and reviewing regulatory documents and publications, our team is committed, passionate, and skilled, with broad knowledge of various therapeutic areas and regulatory requirements. We leverage our scientific expertise to facilitate clear and impactful communication on clinical trial conduct and outcomes. In addition to regulatory document preparation and publishing, our team is responsible for document distribution (via the CONNECT portal) and significantly contributes to NN's regulatory commitments through involvement in public disclosure activities.

The Position:

As a Medical Writer, you will be responsible for ensuring timely, clear, and proactive communication and collaboration with stakeholders and colleagues globally. This role requires effective communication and analytical skills, as well as the ability to work across different time zones and professional environments. To meet deadlines, you must excel in planning your work and proactively address any challenges by seeking help and advice from relevant stakeholders within GBS and Headquarters (HQ). Additionally, you will challenge expert contributors on clinical documents to improve the quality of their written contributions. Your responsibilities include:

• Performing medical writing tasks for trial and/or non-trial activities within clinical reporting, including but not limited to the preparation of Protocols, Clinical Trial Reports (CTRs), Non-interventional study reports (NSRs), Layperson Summary (LPS), Investigator Brochure (IB), and Regulatory response documents (Q&A).
• Communicating clinical data clearly and concisely.
• Contributing to knowledge sharing and maintaining good relationships with stakeholders and colleagues.

Qualifications:

• We are seeking candidates with the following skills and knowledge:
• Graduate degree (PhD, MSc., M Pharm, or equivalent).
• 4+ years of experience as a medical writer or in a relevant role.
• Experience working in a global setting, preferably in the pharmaceutical/CRO industry.
• Strong understanding of external requirements related to regulatory documents.
• Excellent communication skills.
• Ability to work independently on smaller tasks.
• Strong analytical skills.
• Commitment, persistence, and accountability.
• Ability to plan and manage a variable workload.

Job tags

Salary