Document Coordinator

2 weeks ago

Bengaluru, India Merck Full time

Work Your Magic with us

Ready to explore, break barriers, and discover more? We know you’ve got big plans - so do we Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

Position
- Document Coordinator

Job Location - Electronic City - Bangalore

**About the Role**

As a Document Coordinator, you will support the Global Medical Writing Team to deliver its portfolio effectively and efficiently.

Your role would require you to:

- Conduct quality review of Safety documents including but not limited to various Periodic Safety Reports (PBRER, DSUR, ACO etc.), Signal Evaluation Reports, Safety Strategy and Core Benefit-Risk Documents, Risk-Management Plans, and Health Hazard Reports.
- Ability to work within a team in collaborative and supportive role Mentor and train the assigned new joiners/junior Document coordinators
- Participate in meetings related to key MW, QC, and compliance activities.
- Reviews Safety Medical writing deliverables for data accuracy, consistency, editing, and ensuring alignment with the processes, templates and regulations.
- Collaborate cross functionally for continuous improvement of medical writing.

**Who you are**:

- Graduate degree or equivalent job experience with comprehensive Medical Writing knowledge of theories, principles and concepts, MD/PhD or advanced science degree.
- Excellent written and spoken English (including medical terminology) and familiarity with AMA style guide.
- Knowledge of Safety and Regulatory documents
- Pharmacovigilance industry experience (3-5 years related experience in a medical or other relevant pharmaceutical industry experience combined with scientific and regulatory knowledge) required.
- Strong knowledge of regulations and guidelines (FDA, EMA, ICH, EU GVP, etc.).
- Experience in working in electronic document management systems (EDMS) and benefit-risk assessment is beneficial.
- A flexible attitude with respect to work assignments and new learning; readily adapt to changes

**What we offer**:We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress

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