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Senior Medical Writer

3 months ago

Bengaluru, India Biocon Biologics Full time

Job Description


Global Medical Centre of Excellence

Patient Value & Innovation


At Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution, where patients come first. Our ambition is to impact a billion lives by fostering a culture of affordable innovation, patient-centricity, and disruptive thinking. We are a multicultural global company where employees have a purpose and passion to work closely with partners and patients. We have a long-term commitment to bringing high-quality affordable biosimilars to patients all over the globe. We have proven end-to-end expertise from clone development, manufacturing, clinical development, and regulatory approvals to commercialization in developed and emerging markets.


We are seeking a Medical Writer to join our Medical Affairs team at our office in Bangalore, within the Global medical COE organization. The ideal candidate will be responsible for developing and managing a variety of scientific documents that support the strategic objectives of the organization. This role requires a strong understanding of clinical research, regulatory requirements, and the ability to communicate complex scientific information clearly and effectively. The right candidate will be an excellent communicator with an ability to develop meaningful relationships, a strategic thinker that can bridge the complexities of patient care and drug development and access, a collaborator who can successfully lead and influence external and internal stakeholders, and a highly motivated self-starter who is comfortable innovating in an entrepreneurial and fast-paced company environment.


Responsibilities:


  • Planning, organizing, tracking, and archiving clinical and post-marketing regulatory dossiers.
  • Managing stakeholders across line functions and geographies.
  • Developing cross-functional skills in publication writing.
  • Collaborating with the clinical team in developing and strategizing the Clinical Development Plan.
  • Collaborating across line functions in preparing SOPs for Regulatory documents.
  • Interpreting, representing and summarizing clinical and scientific data
  • Managing assigned individual projects and holding complete responsibility throughout the document/project lifecycle.
  • Ensuring consistency at all times with compulsory and voluntary codes of conduct, appropriate legislations and compliance with internal SOPs.
  • Building-up newer competencies and enhance existing competencies; analyzing skill/process gaps and bridging the gaps by developing expertise/process maps.
  • Developing cross-functional skills in publication writing.
  • Training peers in regulatory writing.
  • Mentoring and coaching of direct reportees, if any



Other basic requirements include:


  • Ability to interact with senior internal and external personnel
  • Attention to detail and taking accountability
  • Ability to work across more than a few therapy areas
  • Ability to work across geographies in a global role
  • Create sense of purpose and inspiration in the team
  • Must be able to work in a team environment, working closely with cross-functional teams
  • Collaborate with medical affairs colleagues in other countries/regions and share knowledge and learnings
  • Functional expertise in MS office, Veeva Vault
  • Substantial knowledge and understanding of policies, procedures, and guidelines relevant to medical affairs operations


Qualifications

Bachelor's degree required; advanced degree preferred (e.g., MS, Ph.D., or MD);

Minimum 08 years of medical affairs, Medical Writing, patient access, and advocacy experience in the biopharmaceutical, or relevant non-profit or payer industry.

Must be willing and able to travel.