Senior Specialist Document Coordinator
Job Id: 286858
Location: Electronic City, Bangalore, Karnataka, India
Job Type: Full-time
About the Role
As a Senior Specialist Document Coordinator, you will support the Global Medical Writing Team in delivering its portfolio effectively and efficiently. You will be responsible for conducting quality reviews of clinical and regulatory documents and mentoring junior team members. This role will involve collaborating with various teams for continuous improvement in medical writing and ensuring compliance with regulatory requirements.
Key Responsibilities
Conduct quality reviews of clinical and regulatory documents, including Protocols, Clinical Study Reports, Briefing Books, Investigator Brochures, and Clinical Summary documents.
Work within a team, providing collaborative and supportive roles to ensure smooth workflow.
Mentor and train new joiners and junior document coordinators, enhancing their skills and understanding of processes.
Participate in meetings related to key medical writing (MW), quality control (QC), and compliance activities.
Collaborate cross-functionally for continuous improvement in medical writing practices and procedures.
Who You Are
Education: Graduate or postgraduate degree in BPharm/MPharm, PhD, BDS (Dental), BSc/MSc, or equivalent job experience with comprehensive knowledge of medical writing theories, principles, and concepts.
Experience: 4-7 years of related experience in the pharmaceutical or medical industry, with scientific and regulatory knowledge.
Skills:
Excellent written and spoken English, including medical terminology, with familiarity in AMA style guide.
Knowledge of clinical and regulatory documents.
Knowledge of ICH/Good Clinical Practices (GCP) and CTD guidance.
Flexibility to adapt to new assignments and learning opportunities.
What We Offer
We value diversity and believe it drives excellence and innovation. Our culture encourages personal growth, inclusion, and collaboration, empowering everyone to make a meaningful impact.
Apply now and become a part of our diverse team!
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Siliguri |Jharkhand :
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B.G Nagara | Bangalore | Belgaum | Bengaluru | Bommasandra | Mangaluru | Mysore | Udupi |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Madhya Pradesh :
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Detroit | Houghton Lake | Macomb | Southfield |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Missouri :
Fulton | Milan | St. Louis |Nebraska :
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China | Quarry Bay |Hubei :
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Remote - Middle East | Remote, USA | Lenexa | Remote - Europe | McFarland | Remote - South America (Latin Americal) | Remote - Africa | Switzerland | Remote | Melbourne | Victoria |Bucharest :
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Madrid |Sweden :
Sweden |Taipei :
Taipei |Williamson :
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Ho Chi Minh City |