Technical Writer – Pharmaceutical Sciences Job Vacancy in Alvotech India – Latest Jobs in India

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Company Name : Alvotech
Location : India
Position : Technical Writer – Pharmaceutical Sciences

Job Description : Overview of Role
The technical writer sits within the PharmSci Strategy team and support the whole Pharmaceutical sciences department in preparing documentation linked to development projects, as well as dossier writing. He/she is responsible for working closely with subject matter experts within the different fields of PharmSci (cell line-, upstream-, downstream and drug product process development, and analytics) in order to write protocols and reports for different development studies. In addition, the technical writer works closely with both SMEs and the regulatory function to translate source documents to dossier content for the final submissions (MAA, BLA etc).
Scope and responsibility
Documentation including, but not limited to, stability protocols and reports for drug substance and drug product, including forced degradation and similarity assessment studies
Work with internal teams and individuals to obtain information required for the documents. This involves interactions with Pharmaceutical Sciences employees, as well as cross-functional teams (e.g. program teams, Quality Control, Quality Assurance, Manufacturing, Regulatory)
Research, outline, write, and edit new and existing content, working closely with various departments to understand program requirements.
Independently gather information from SMEs that is required for the intended document.
Write up documents after initial and continued discussions with and support from SMEs.
Utilize correct templates for the intended audience.
Generate templates for different types of documents that can be used as an easy starting point for future projects
Translate source documents to dossier content
Job requirements
BSc in a scientific subject, preferably Biotechnology or similar
Experience in technical report writing
Sound scientific background with experience in data gathering, summarizing and evaluation
Good working knowledge and experience with Word and Excel essential, including figure generation. Any additional programs are a benefit, e.g. Prism (GraphPad), JMP
Antibody and/or protein structure knowledge desired and knowledge of/experience with protein manufacturing, or within any of the PharmSci areas (cell line-, upstream-, downstream or drug product process development, or protein analytics) beneficial
Ability to work independently
Ability to work cross-functionally with people from various departments
Ability to multitask with several projects at the same time
Flexible and can-do attitude
About the Department/Company
Alvotech is a fully integrated specialty biopharmaceutical company focused exclusively on development and manufacturing of high quality biosimilar products. We are specialists in biopharmaceutical product creation, all along the value chain from cell line development to commercial manufacturing. Our common goal: to be a global leader in the biosimilar space and to deliver high quality cost competitive products to patients worldwide.
The Pharmaceutical Sciences department within Alvotech is made up of cell line-, upstream-, downstream- and drug product development, as well as analytical research and development, PharmSci Excellence and PharmSci Strategy. PharmSci Strategy are responsible for developing strategies within the PharmSci area in a collaborative manner, including stability, specifications and analytical similarity strategies.

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