Job description
Overview:
Lupin is comprised of a fast growing, innovative and robust team of manufacturing, Research and Development and commercial divisions. Together these entities make up the generic and branded U.S. business. Lupin has a significant generic pipeline, and a branded focus on women’s health. Our first Research and Development facility in the US is located in Coral Springs, Florida which focuses on generic and branded orally inhaled and nasal drug products. Somerset, New Jersey is home to one of twelve commercial manufacturing sites globally and the only commercial manufacturing facility in the United States for Lupin, as well as additional Research and Development teams. Lupin is prided on being people-focused and centered around how impactful we are with our customers. Dollars are not a measure of success but rather the people we help along the way.
Responsibilities:
Lupin’s presence in the United States is comprised of a diverse workforce encompassing manufacturing, research and development, and commercial divisions for generics, complex generics, biosimilars and branded pharmaceuticals. We’re searching for an experienced technical writer to join our team and help take our regulatory authority focused services to new heights
- The Regulatory and Compliance Technical Writer will be responsible for developing, writing, and editing any investigation reports as designated, inspectional observation and any other regulatory compliance responses. The Regulatory Compliance Writer will work as part of the Regulatory Compliance team and will work closely with team leaders and subject matter experts to develop and deliver compelling content. The Regulatory Writer will assist with formatting and rigorous copy editing, develop comprehensive documentation that meets organizational standards.
- The position requires close collaboration with internal subject matter experts in a range of disciplines including regulatory, analytical, compliance and external specialist preferred providers to synthesize and present information from such disciplines clearly and accurately.
- Author and assist in the preparation of high-quality scientific documents destined for regulatory submission, in cooperation with internal subject matter experts and from time to time working with external agencies and consultants.
- Communicate complex scientific information following applicable writing styles.
- Research, outline, write, and edit new and existing content, working closely with various departments to understand project requirements
- Work with development and support leads to identify all documentation repositories, revise and edit, and determine the best solution for data compilation and centralized storage
- Develop and maintain detailed databases of appropriate reference materials, including research, usability tests, and design specifications
- Evaluate current content and develop innovative approaches for improvement
- Master’s in regulatory sciences / Law Degree in relevant technical field
- 8+ years of relevant pharmaceutical/biotech/healthcare industry experience.
- Experience as an effective technical writer
- Excellent verbal and written skills
- Good communication and interpersonal skills with an ability to work effectively in a team environment and at all levels of the organization
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