Biocon Biologics is at the forefront of healthcare innovation, revolutionizing biosimilars for a patient-centric future. With a mission to impact a billion lives, Biocon Biologics focuses on affordability, innovation, and high-quality biosimilars. From development to commercialization, the company’s global reach and commitment to excellence drive its leadership in the healthcare industry. Join Biocon Biologics and contribute to a global model of affordable healthcare.
Medical Writer – Global Medical Center of Excellence, Patient Value & Innovation
Responsibilities
As a Medical Writer, your role will involve strategic document development and project management within Biocon Biologics’ Medical Affairs team in Bangalore. Responsibilities include:
- Regulatory Dossier Management: Planning, organizing, tracking, and archiving clinical and post-marketing regulatory dossiers.
- Stakeholder Collaboration: Managing cross-functional stakeholders across various geographies.
- Publication Writing: Developing skills in scientific publication writing.
- Clinical Development Strategy: Collaborating with the clinical team to strategize and develop the Clinical Development Plan.
- Regulatory SOPs: Preparing SOPs across different line functions for regulatory documents.
- Scientific Data Interpretation: Summarizing complex clinical and scientific data for stakeholders.
- Project Ownership: Managing individual projects from inception to completion, ensuring compliance with all relevant regulations and internal SOPs.
- Skill Development: Enhancing cross-functional competencies and training peers in regulatory writing.
- Mentorship: Mentoring and coaching team members, fostering a collaborative environment.
Qualifications
- Bachelor’s degree required; advanced degrees such as MS, Ph.D., or MD preferred.
- A minimum of 3 years of experience in medical writing, preferably within the biopharmaceutical sector.
- Strong understanding of clinical research and regulatory requirements.
- Willingness to travel as needed.
Skills Required
- Expertise in MS Office and Veeva Vault.
- Ability to work across therapy areas and geographies.
- Strong communication skills for interacting with senior stakeholders.
- Experience in medical affairs, patient access, and advocacy.
- Leadership and mentorship abilities within a fast-paced, cross-functional team.
