Medical Writing Lead
Company: Alvotech
Location: Bangalore, India (Partially Remote)
Job Type: Full-Time
Experience: Typically 7+ Years (Medical Writing) + 3+ Years (Team Leadership)
Qualification: MSc / PhD / PharmD / MD or related Life Sciences discipline
Salary Range: Not Specified
Job Overview
Alvotech is seeking a Medical Writing Lead to oversee scientific and regulatory documentation across the full product lifecycle.
The Medical Writing Lead will be responsible for managing end-to-end medical writing activities from clinical development through post-marketing phases, while also leading and mentoring a team of medical writers. The role requires strong expertise in translating complex clinical, scientific, and safety data into high-quality regulatory and scientific documents.
This position is ideal for experienced medical writers with leadership capabilities and a strong background in regulatory writing.
Key Responsibilities
Medical Writing Leadership
Lead and manage a team of medical writers.
Coordinate writing activities and ensure timely delivery of documents.
Provide mentorship, guidance, and quality oversight for the team.
Clinical Development Documentation
Lead preparation of key clinical documents including protocols, protocol amendments, and Clinical Study Reports (CSRs).
Develop clinical safety sections aligned with overall safety strategy.
Ensure documents meet regulatory and scientific standards.
Post-Marketing & PV Writing
Guide development of scientific publications.
Manage pharmacovigilance-related writing activities.
Ensure consistency and compliance in post-marketing documentation.
Scientific Communication & Data Interpretation
Translate complex scientific and clinical data into clear, concise documents.
Collaborate with teams to interpret and present data effectively.
Ensure high-quality scientific storytelling and accuracy.
Cross-Functional Collaboration
Work closely with Clinical Development, Biostatistics, and Pharmacovigilance teams.
Align documentation with regulatory and clinical strategies.
Support submission readiness and regulatory interactions.
Document Management & Compliance
Oversee document planning, tracking, and delivery timelines.
Ensure compliance with global regulations including GCP and ICH guidelines.
Utilize document management systems effectively.
Required Skills
Medical Writing Expertise
Extensive experience in writing regulatory and scientific documents (IBs, CSRs, protocols, submissions, safety reports, publications).
Strong understanding of clinical development and regulatory requirements.
Excellent scientific writing and editing skills.
Leadership & Management
Experience managing and mentoring medical writing teams.
Ability to coordinate multiple projects and stakeholders.
Strong decision-making and organizational skills.
Regulatory & Compliance Knowledge
Knowledge of GCP, pharmacovigilance regulations, and ICH guidelines.
Experience supporting global regulatory submissions.
Understanding of lifecycle documentation requirements.
Communication & Collaboration
Strong interpersonal and communication skills.
Experience working in multicultural and cross-functional teams.
Ability to simplify complex data into meaningful insights.
Preferred Qualifications
Experience in biosimilar clinical trials.
Experience with document management systems.
Exposure to global regulatory environments.
Key Competencies
Medical writing and regulatory documentation
Team leadership and coordination
Scientific communication and data interpretation
Clinical and post-marketing documentation
Regulatory compliance (GCP, ICH, PV)
Cross-functional collaboration
About the Company
Alvotech is a fully integrated specialty biopharmaceutical company focused on developing and manufacturing high-quality biosimilar medicines.
Through its Integrated Clinical and Medical Research (iCMR) function, the organization drives clinical strategies aligned with global regulatory requirements, enabling successful clinical development and post-marketing activities worldwide.
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