Showing posts with label Eli Lilly. Show all posts
Showing posts with label Eli Lilly. Show all posts

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We got a new job details in Eli Lilly & they are Hiring Candidates for Medical Affairs Medical Writing

Job Details
Company Name :
Eli Lilly
Company Location :
Bengaluru, Karnataka
Job Position :
Medical Affairs Medical Writing
Job Category : Jobs in Bengaluru

Job Description :
Job Description

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Medical Affairs – Medical Writing Position title/level may vary by site or geographic location Purpose: Scientific data and information are core assets of Lilly. Providing balanced, objective , and accurate information to regulators, the scientific community, health care professionals, payers , and patients in a consistent and timely fashion across the entire drug development lifecycle is fundamental to Lilly. As healthcare providers are deluged with data and are making choices in an increasingly complex and stressed health system, Lilly Medical Affairs is able to provide clear, credible answers that will set Lilly apart from its competitors. Medical Affairs’ mission is to make Lilly the preferred pharmaceutical partner in the healthcare community globally by leveraging its medical expertise to drive patient-centric answers and solutions. Medical Affairs (MA) brings deep medical expertise to healthcare providers and payers. MA focuses on answering their questions with customized clinical and real-world evidence that can make the difference on if and how they use Lilly products. Additionally, MA brings clinical insights from customers back to the company to inform new product development and lifecycle planning. MA also supports patients with educational tools to help them manage their illness and with assistance to access our medicines for those facing tough financial situations. The MA content development team will be key in maintaining and creating content to support Medical Affairs activities such as:

Slide Updates
Internal Training Slides
Manuscript Slides
Data Slides

Newsletters/ bulletin
QR Compendium
Affiliate Regional Slides
HCP & patient education material
Advisory board slides

Competitive landscape slides
Image sourcing, image redraws
Lexicon
MQAD (Medical Questions Analysis Document)

Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

EMS (Executive Medical Summary)
Content Strategy and Execution: Document Preparation, Development and Finalization/Document Management

Effectively collect and evaluate data, information, and input from multiple sources, functions, and regions to create a cohesive content strategy for writing projects.

Plan (including organizing/preparing outlines), write (including first-draft authoring), edit, review, coordinate, and complete the regulatory documents supporting clinical development/product registration.
Conduct effective document initiation meeting to ensure authoring team alignment and understanding.
Build scientific-based rationale that support the purpose of more complex and/or strategic documents.
Ensure data are presented in a clear, complete, accurate, and concise manner.
Ensure that key data, statements and conclusions are consistent across related documents, and that statements and conclusions are integrated, accurate, balanced and supported by appropriate data.

Coordinate expert/scientific reviews, collate reviewer’s comments, adjust content of document as required based on internal/external input, and prepare final version.
Ensure and coordinate quality checks for accuracy .
Exhibit flexibility in moving across development and preparation of multiple document types.
Influence or negotiate change of timelines and content with other team members.
Work with internal and external experts to develop and prepare presentations.

As needed, m ay build and manage relationships with vendors/alliance partners .

Project and Stakeholder management

Lead the writing process and apply effective project management skills to ensure timely completion of high-quality regulatory documents.
Build/communicate credible writing project timelines .

Anticipate and mitigate risks to delivery
Work with teams and stakeholders to ensure smooth and timely development of documents and escalate issues, as appropriate, to ensure document completion.
Effectively communicate project status to stakeholders

Knowledge and Skills Development

Maintain and enhance therapeutic area knowledge including disease state and compound(s) for assigned project(s).

Exhibit flexibility in moving across document types, therapeutic areas, and compounds, depending on project assignment.
Maintain and enhance knowledge of regulatory guidelines and publication guidelines.
Possess overarching view of compound, therapeutic area, and external environment (including competitors) with ability to participate effectively in clinical planning, submission strategy planning, customer regulatory responses, and/or current awareness literature updates and reviews.
Maintain and enhance the scientific communications skills to align with the audience needs and with the changes in technology and platforms.

Knowledge Sharing

Provide coaching to others by sharing technical information, giving guidance, answering questions. 
Recognized for technical expertise in specific document development.
Network with others (including other functions and regions) to identify and share best practices.

Contribute to process improvements, suggesting opportunities where appropriate.
Provide database and other tool (e.g., document management systems) expertise.

Minimum Qualification
Requirements:

Bachelor’s degree in a scientific, health, communications, technology health related field .
Demonstrated experience in technical/ regulatory scientific writing .
Strong communication and interpersonal skills.
Successful completion of writing exercise (a writing exercise is required as part of the candidate evaluation process )

Other Information/Additional
Preferences:

Graduate degree with formal research component or in life sciences.
Demonstrated mastery of verbal and written English skills in the medical, scientific or technical writing fields .

Clinical pharmacology, therapeutic area, or other medical and scientific specific knowledge and experience specific to hiring area (e.g., neuroscience, oncology, cardiovascular, immunology or endocrine expertise).
Experience writing regulatory, clinical trial documents and/or publications
Experience writing deliverables for Medical Affairs communications (slide decks, patient or HCP materials, etc )
Experience in clinical development, clinical trial process or regulatory activities .
Demonstrated project management and time management skills.

Demonstrated high-level end-user computer skills (e.g., word processing, tables and graphics, spreadsheets, presentation and templates).
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response. Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Job Detail

Job Id

JD2178141

Industry

Not mentioned

Total Positions

1

Job Type:

Full Time

Salary:

Not mentioned

Employment Status

Permanent

Job Location

Bengaluru, Karnataka, India

Education

Not mentioned

Experience

Year

Disclaimer : We are just publishing information regarding new job openings and not legally responsible for any Post. Candidates are requested not to pay any money to anyone posing as webeservices.co

Hi, Looking for a New Job? Webeservices.co is one stop place for searching new job openings.
We got a new job details in Eli Lilly & they are Hiring Candidates for Associate Scientist

Job Details
Company Name :
Eli Lilly
Company Location :
Bengaluru, Karnataka
Job Position :
Associate Scientist
Job Category : Jobs in Bengaluru

Job Description :
Job Description

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
Overview of the organization Bioproduct Research and Development (BRD) is an innovation-focused organization within Eli Lilly and Company. BRD is involved in key activities for the development of parenteral biologics drug substance and drug products including chemically-synthesized biomolecule drug products from pre-clinical phases through commercialization. Our dynamic department is made up of molecular and cell biologists, purification and process engineers, pharmaceutical scientists, analytical chemists, and engineers. We strive to identify, develop, and apply groundbreaking technologies to deliver maximum benefit to our patients. BRD delivers on these responsibilities by recognizing diverse talent and cultures are vital to bring the next generation of life changing medicines to patients. BRD Analytical is a flexible, cross-functionally integrated, and capabilities driven team within BRD committed to providing state of the art measurement sciences to guide product and process understanding leading to optimized control strategies. Our mission is to elucidate understanding at molecular level, define critical quality attributes, integration of CMC knowledge, establish new platforms and technologies, and achieve regulatory acceptance to commercialize life changing medicines.
Main Purpose and Objectives of Position As part of a multi-disciplinary team in BRD Analytical, the incumbent will provide oversight and support for GMP analytical testing (i.e. lot release and stability) for clinical trial materials, primary stability studies and technology transfers. Job responsibilities include providing oversight for the analysis of a variety of active pharmaceutical ingredients and dosage forms to evaluate stability, and support clinical trial materials; qualification, verification, and validation of analytical methods; transfer of analytical methods and techniques to third party testing laboratories; and reference standard support activities. These activities may include use of data and information in NuGenesis, Trackwise, Veeva Vault, and other systems.
Key Responsibilities

Understands and follows all relevant policies relating to this job including business, compliance, regulatory, quality, environmental, and safety expectations. May participate in the development and review of procedures, policies, and training materials associated with the area.
Demonstrates understanding and experience with GMP requirements

Develops and maintains awareness and familiarity of ICH guidelines and other global regulations and guidance documents.

Demonstrates strong analytical skills

Demonstrates technical capability in reviewing and interpreting lot release and stability data for a select number of active pharmaceutical ingredients and pharmaceutical dosage forms in the LRL portfolio.
Oversight of transfer/verification/qualification/validation of methods to support in-process, release, characterization analysis, and stability testing of active pharmaceutical ingredient and drug product.
Experience with various analytical instrumentation and techniques (e.g., HPLC, CE, UV, various types of compendial testing)

Demonstrates project management and communication skills

Efficiently and effectively manages project deliverables to provide support for multiple projects in multiple phases of development.
Effectively guide and oversee external work at collaboration partners.
Generates, interprets, troubleshoots and effectively communicates (both in writing and orally) relevant information to management, team members, project leaders, and customers.
Develops and maintains successful partnerships with other Lilly scientists, regulatory representatives, QA representatives and third-party collaboration partners

Demonstrates good documentation skills

Author protocols, reports, and change controls to support lot release and stability testing, dating, temperature excursions and registration of API and drug product.
Ensures the accuracy of the data/information entered into IT systems.
Demonstrates proficiency at data reporting, interpretation, and trending (e.g., Empower chromatography software and electronic laboratory notebooks).

Demonstrates understanding and experience with laboratory and stability systems and tools

Demonstrates proficiency in performing basic operations in common informatics tools.
Demonstrates capability and expertise in utilization of Trackwise to document events and changes; familiar with ServiceNow.

Educational Requirements B.S. or M.S. in Chemistry, Pharmaceutics or related field and significant pharmaceutical industry experience.
Experience Requirements For the above activities, an individual in this role requires:

Fundamental knowledge of cGMP compliance requirements and pharmaceutical stability principles.
Previous pharmaceutical industry experience (at least 3-5 years) required
Good documentation skills and ability to author and/or review standards, guidelines, SOPs, templates, protocols, and other GMP documentation.
Excellent general computer skills (MS Excel, Internet Explorer, PowerPoint, MS-Word) and the ability to compile, summarize and present information to diverse groups.
Excellent communication skills and willingness to interact with laboratory personnel, contractors and management.
Ability to troubleshoot problems and identify solutions.
Ability to influence and partner with individuals outside of a formal reporting relationship towards realization of team goals.
Customer-focused attitude

License/Certificate Requirements N/A Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response. Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Job Detail

Job Id

JD2336310

Industry

Not mentioned

Total Positions

1

Job Type:

Full Time

Salary:

Not mentioned

Employment Status

Permanent

Job Location

Bengaluru, Karnataka, India

Education

Not mentioned

Experience

Year

Disclaimer : We are just publishing information regarding new job openings and not legally responsible for any Post. Candidates are requested not to pay any money to anyone posing as webeservices.co

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