15h Left: Manager Document Coordinator

Job Description

Work Your Magic with us

Ready to explore, break barriers, and discover more We know youve got big plans so do we Our colleagues across the globe love innovating with science and technology to enrich peoples 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&aposs 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.

As the Senior Manager Document Coordinator, you are a true leader that will support the Global Medical Writing Team to deliver its portfolio effectively and efficiently. You will demonstrate leadership skills in delivering in a matrix organization towards both, the team based in our R&D Hub in India and the global Medical Writing Team (support best practice, drive innovation, adhere to processes).

Your Role Would Require You To

- Independently oversee and conduct quality review of clinical and regulatory documents including but not limited to Protocols, Clinical Study Reports, Briefing Books, Investigator Brochures, and Clinical Summary documents
- Allocate and prioritize quality check and compliance activities
- Represent QC team in the meetings with internal and external stakeholders.
- Lead and motivate the Clinical MW team in Bangalore, India
- Mentor and train the assigned new joiners/junior Document coordinators
- Participate in meetings related to key MW, QC, and compliance activities
- Collaborate cross functionally for continuous improvement of standards and best practices for 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.
- > 12 years related experience in a medical or other relevant pharmaceutical industry experience combined with scientific, safety, and regulatory knowledge
- Excellent written and spoken English (including medical terminology) and familiarity with AMA style guide.
- Understanding of Team lead activities in the QC area, including building a team, performance management, metrics management, budgeting, resourcing, compliance and achieving the defined KPIs.
- In-depth knowledge of Clinical, Regulatory, and Safety documents
- Profound pharmaceutical industry experience (more than 10 years experience in a medical or other relevant pharmaceutical industry experience combined with scientific and regulatory knowledge) required.
- In-depth knowledge of ICH/Good Clinical Practices, CTD guidance, FDA regulations, and the drug development process.
- Comprehensive experience in working with cross-functional, global teams, and vendor resources across different regions and time zones.
- 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 believe that this variety 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

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity

---