Manager - Submission Management

Role overview

Manager - Submission Management at Merck

The role will support the resolution of complex tasks, under close supervision and guidance provided from the more experienced Publishing & Submission Management professionals.

Responsibilities

• Work Your Magic with us!

Required qualifications

• Ensuring sustainability of knowledge, capability, and capacity required for the book of work, aligning with long-term organizational strategies.
• B.Pharm, M.Pharm, MBA or Post graduate in Science .
• Work Experience. 9 - 11 years of professional experience with Regulatory Publishing/Submission Management.
• Job specific Competencies & Skills.
• Key contact for eCTD and Publishing expertise.
• Act as power-user for submission applications (RIM, eDMS, eSM).
• Monitor compliance with submission standards and submission process (internal & external).
• Manage and improve quality of submission standards and templates for submission-relevant documents ensuring compliance with HA requirements.

Employment details

• Location: Bangalore [Karnataka] [India]

About the employer

• Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life.

Benefits

• 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.
• 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.
• 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!

Additional role details

• Ready to explore, break barriers, and discover more?
• We know you’ve got big plans – so do we!
• 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.
• Accountability/Interdependence.
• Provide leadership and direction for the Submission Management sub-team within Submission Management.
• Accountable for performance and results of Submission Management sub-team team by coordinating and supervising work as a team leader and by monitoring progress, timeliness, completion and quality.
• Supervises the day-to-day business of the Submission Management sub-team.
• Can perform the work supervised, but typically focuses on the more complex/complicated topics and on managing the team.
• Applies technical expertise in the analysis of factual information and may even look beyond the immediate problem and use business acumen to understand the wider implications.
• Acts within clear guidelines and receives guidance and oversight from manager to set team goals and priorities.
• Responsible for day-to-day management, setting commitments, coaching and developing employees, performance appraisal, determination of reward outcomes.
• Coordinating training initiatives, including onboarding of new hires, and coaching and mentoring team members.
• Collaborating with the RQS Operations team to establish KPIs and ensure adherence to them, including communication to RQS Operations functions to support overall goals.
• Impact.
• Ensuring compliance with Health Authority requirements, functional SOPs, and other internal guidance to support the overall strategic objectives of the organization.
• Streamlining submission processing by guiding and harmonizing activities across functional areas to optimize regulatory operations in line with strategic goals.
• Complexity.
• Position will be working in a matrix organization, with extensive communication and collaboration with stakeholders from various functions within or outside Global Regulatory Affairs.
• Scope of people responsibility.
• Resource planning, hiring, performance management.
• Coordinate training and people development, compensation and benefits.
• Ensuring a positive and inclusive workplace culture applying diversity and inclusion.
• Cultivate employee engagement and well-being.