Medical Writer Job at Merck
Are you passionate about patient safety and seeking a role that makes a difference? A rare chance has emerged at Merck for professionals seeking to contribute to patient safety as a Senior Specialist / Expert – Safety Medical Writer in Bangalore, Karnataka. This Medical Writer Job in Bangalore invites candidates with a strong background in pharmacovigilance to apply. At Merck, innovation meets dedication, providing a platform for career growth and personal development. Explore this opportunity to join a global leader in healthcare and make your mark in the industry.
About Merck:
Merck is a global healthcare company that operates in the pharmaceutical, life science, and electronics sectors. With a commitment to improving and prolonging lives, Merck develops innovative medicines and intelligent devices across various therapeutic areas, including oncology, neurology, and fertility. The organization fosters a diverse and inclusive culture, providing opportunities for personal development and career advancement worldwide.
Job Details:
- Job ID: 302844
- Location: Bangalore, Karnataka, India
- Job Type: Full-time
Key Responsibilities:
- Support Global Patient Safety (GPS) Safety Scientists and Safety Strategy Leads with regard to safety medical writing (SMW) activities.
- Assist senior staff in developing sections of a wide range of pharmacovigilance documents, including but not limited to various Periodic Safety Reports, Signal Assessment Reports, Safety Strategy and Core Benefit-Risk Documents, Risk-Management Plans, Patient Safety Narratives and Health Hazard Reports.
- Responsible for proofreading, building and populating tables and drafting appendices.
- Produce high-quality, accurate and fit-for-purpose documents with clear conclusions.
- Effectively and clearly communicate technical, medical, and scientific information in critical submissions and internal PV documents to deliver high-quality reports within the specified timelines at Merck Careers.
- Performs quality control of SMW deliverables for data accuracy, consistency, editing, and ensuring alignment with the processes, templates and regulations in the Medical Writer Job in Bangalore.
- Participates in meetings related to key PV activities.
- Collaborate cross-functionally for continuous improvement of standards and best practices for medical writing.
Eligibility Requirements for Medical Writer Job:
- Graduate degree or equivalent job experience with comprehensive pharmacovigilance knowledge of theories, principles and concepts; MD/PhD or advanced science degree.
- Excellent written and spoken English (including medical terminology) with a familiarity with the AMA style guide.
- Profound pharmacovigilance experience (including 5 to 8 years’ experience in PSRs) required.
- Demonstrated experience in Periodic Safety Reports, including interpretation & presentation of aggregate safety data.
- Strong knowledge of regulations and guidelines (FDA, EMA, ICH, EU GVP, etc.).
- Experience working in electronic document management systems (EDMS), signal management and benefit-risk assessment is beneficial.
- Proven experience and ability to consistently produce documents of high quality and express complex data in a concise and easy-to-read way.
- Comprehensive experience in working in cross-functional, global teams, across different regions and time zones.
- A flexible attitude with respect to work assignments and new learning; readily adapts to changes.
What We Offer?
Merck is committed to fostering a culture of inclusion and belonging that empowers individuals to work their magic and champion human progress. The organisation values diverse perspectives and life experiences, believing that this variety drives excellence and innovation. Join Merck in building a workplace that impacts millions and provides opportunities for personal growth.
