Senior Medical Writer Job Vacancy in Alvotech India – Updated today
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Full Details :
Company Name : Alvotech
Location : India
Position :
Job Description : Overview of Role
The Senior Medical Writer will be responsible for supporting the authoring and preparation of clinical study documents and sections of regulatory submissions for assigned clinical programs/trials. The Senior Medical Writer may also support authoring of scientific documents such as abstracts and publications.
Scope and responsibility :
Support the authoring and preparation of clinical study and regulatory documents including clinical study protocols, clinical study protocol amendments, clinical study reports, investigator’s brochures, and sections of regulatory submissions.
Assist with the authoring of other more complex scientific documents such as abstracts and publications. Provide basic medical writing support for documents produced by other departments.
Coordinate the efforts of cross-functional teams to produce high-quality, scientifically accurate documents and ensure consistency between related documents.
Manage timelines and communicate with team members to maintain awareness of expectations, milestones, and deliverables.
Oversee outsourced medical writing activities.
Perform Quality Control (QC) review of documents or parts of documents prepared by other staff.
Support implementing and improving policies, Standard Operating Procedures (SOPs) and Work Instructions (WIs), as required.
Serve as the lead medical writer for clinical studies, attend study team meetings as needed, and contribute medical writing input to support study and program planning and execution.
Accountable for the format, content and adherence to regulatory and electronic publishing standards of the individual documents.
Responsible for document management activities, maintain the document lifecycle in the system.
Job requirements:
Education: A minimum of Master’s Degree in Life Science or related field, or a Advanced Degree (MD, Pharm.D. or PhD) related field is a plus.
Experience: 5+ years in medical writing functions in the Pharmaceutical Industry, or equivalent.
Demonstrated ability to interact collaboratively in a cross-functional environment required.
Organization and Management Skills: Required to lead, participate and make positive contribution to team meetings.
ICH-GCP Experience: Good knowledge and understanding of ICH-GCP. Will participate in internal and external audits as well as regulatory inspections.
Experience with document management tools, familiar with document management workflow systems.
This position is home-based, but may include occasional onsite attendance and travelling.
About the Department/Company
Alvotech is a fully integrated specialty biopharmaceutical company focused exclusively on development and manufacturing of high-quality biosimilar medicines. Within R&D, the Clinical and Medical Affairs department develops effective strategies aligned with biosimilar guidelines and health authority requirements to deliver successful clinical studies.
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