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Showing posts with label CR. Show all posts
Showing posts with label CR. Show all posts

Friday, 11 July 2014

Senior Medical Writer position vacant in Novartis Hyderabad, D4

Job ID :133148BR 

Position Title : Senior Medical Writer 

Division : Vaccines & Diagnostics 

Business Unit :Global Development 

Country : India 

Work Location : Hyderabad 

Company/Legal Entity : Nov Hltcr Shared Services Ind 

Functional Area : Development & Medical 

Job Type : Full Time 

Employment Type : Regular 

Job Description 

To meet the business need of writing high quality clinical study documents for submission to regulatory authorities in support of marketing applications and other medical writing needs through writing and coordinating, timelines and quality, managing customer expectations and providing other medical writing support to global teams. • Write, edit and co-coordinate preparation of Clinical Study Reports (CSR) • Drive the CSR process and coordinate a medical and scientific team within a matrix • Participate in review of analysis plan and advise on required tables • Develop and maintain effective working relationships among document contributors on multifunctional platforms • Ensure reviewers and other contributors are identified and can perform tasks according to the agreed process • Ensure CSR process is completed according to SOP within the time specified by the SOP or otherwise agreed with the team, whicever is shorter. • CSR tracking and status reporting, including identifying milestone timelines • Contribute to the development of both, the CSR process and product, to match changing business needs • Obtain feedback from customers; and help define and implement customer management • Support process improvement initiatives • Comply with and support group's project management tool, standards, policies and initiatives • Maintain records for all assigned projects including archiving • Help maintain audit, SOP and training compliance • Train and mentor new joiners, fellow colleagues as and when required 

Minimum requirements 

B.Sc/ M.Sc in a scientific discipline, Doctoral Degree or MD is desiredDesired – Doctoral Degree or Qualification in Medical Sciences (MBBS/MD/equivalent) Fluency in written and spoken English with strong ability to interpret and present data Five years of experience in medical/scientific writing As and when required for trainings, meetings and audits


Apply online


Thursday, 10 July 2014

Fresher M Pharma/ Fresher BDS / Fresher MBBS can apply for Clinical Trial Assistant D3

Job description

Position Details : Clinical Trial Analyst 

Designation: Clinical Trial Analyst

Experience : 0 to 2 years

Position Type : Full Time

Functional Area : Scientific Content

Education : B.D.S, M.Pharm, MBBS

Work Location : Bangalore

Job Description 

1.To Review of various clinical trial protocols and source documents.

2.Clinical trial data analysis, tagging and updating the database.

3.Advise data management staff on trial parameters, database designs, and validation of
critical data.

4.Reports progress and changes in clinical trials.

5.Statistical analysis and competitive analysis of trial results.

Desired Profile 

1.Should have a qualified MBBS, BDS, M Pharm Degree.

2.A strong educational background in clinical research.

3.Computer skills including use of Microsoft word, excel and power point.

4.In depth therapeutic and clinical research expertise as well as knowledge of
GCP/ICH and applicable regulatory guidelines.

Soft Skills

·Client focus

·Result orientation

·Communicating with Impact

·Team player

·Process oriented



Opening in Data Management for Associate Manager, Clinical Data Analyst @ Paraxel Hyderabad D2

About the Company:


At PAREXEL, we have a passion for making a profound difference. As an expertise-based business, the caliber of our people and their dedication directly impacts our success, the success of our clients, and the ability to make a difference in the lives of patients worldwide. You'll be surrounded by supportive leadership and a brilliant team who share a common goal — to improve the lives of millions of patients. 

Job Description 

Manage and oversee team activities including appropriate resourcing of staff, staff assignments, and quality control of project deliverables and timely delivery of project deliverables.
Monitor performance close interaction with PL/GRO Lead
Train, mentor and allocate team members according to their ability
Provide technical support to team members to ensure that they have the required knowledge to fulfill their duties.
Check quality of team deliverables (e.g., on site visits, Central File documentation) and take appropriate remedial action.
Meet and aim to exceed client expectations by recruiting, retaining and developing a skilled, experienced and motivated team.
Maintain an agreed level of productivity/billability and staff turnover.
Participate in and contribute to Project bids, including client presentations.
Meet client and business needs to have all projects optimally resourced with suitably experienced staff.
Ensure direct reports meet departmental and project productivity and quality metrics by efficient execution of their project in line with project plan.
Meet percentage of travel and billability guidelines for staff as appropriate.
Produce accurate resourcing plans in conjunction with the appropriate Project Team Members.
Provide consultation, facilitate metrics collection and develop action plans in conjunction with
Management/Project Leadership/Leads to keep project on time and within budget.
May be responsible for own assignments as project team member. This includes taking the role of a senior level contributor on a project team and ensuring high quality and timely delivery of own deliverables.
May be responsible to coordinate client or account activities for department or function.
Prepare and submit weekly study specific status reports to Project Team, Sponsors and management and attend project team meetings.
Serve as an ongoing liaison with Project Team, Sponsor and management regarding performance of direct reports.
Manage and develop the team to ensure their performance meets and or exceeds both the business and their own personal goals/objectives
Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced and objective manner
Participate in formal staff review processes e.g. performance and salary reviews to corporate standards and timescales.
Maintain a working knowledge of, and assure compliance with, applicable ICH Guidelines, Good
Clinical Practices, Regulatory Agency requirements, and PAREXEL WSOPs.
Participate in PXL and department system/standards improvement activities.
Support efforts for generating business leads (client networking, public speaking, etc.).
Complete routine administrative tasks in a timely manner (e.g. timesheets, metrics, travel expense claims
Departmental or Project tasks as assigned. 

Qualifications 

 Substantial data management experience or equal experience in clinical research. Must be able to demonstrate knowledge/proficiency with several data management. Previous relevant 7 to 9 years data management and 2-3 years of management experience required with solid understanding of clinical trials methodology and terminology desirable.

Apply online


Vacancy for Clinical Data Manager @ Novartis Hyderabad, D1

Job description

Job ID - 127177BR

Position Title - Clinical Data Manager

Division - Pharma

Business Unit 

Pharma - Oncology

Country - India

Work Location - Hyderabad

Company/Legal Entity - India Novartis Healthcare Private Limited

Functional Area - Research

Therapeutic/Disease Area - Oncology

Job Type - Full Time

Employment Type -Regular 

Job Description 

Clinical Data Manager
Provide timely and professional ongoing management of clinical trial data by identifying and resolving errors and inconsistencies in eCRF data to ensure consistently high standard database(s) with respect to cost, quality and timelines. 
1.Provide professional DM input on Clinical Trial Team(s) 
2.Input to and review of clinical trial database design including User Acceptance Testing (UAT). 
3.Responsible for the Validation and Analysis Plan (VAP) meeting for the clinical trial, which includes chairing the meeting, writing the study specific validation checks and necessary reports to ensure high quality and consistent data.
 4.Identify errors and inconsistencies; resolve them or initiate their resolution either via the field monitor or directly with the investigational site, to ensure high quality and timely database locks.
 5.Review and contribute to preparation of protocols, specifically related to the data management section, visit schema and study design.
 6.Prepare Case Report Forms (CRFs) and CRF completion Guidelines (CCGs), electronic or paper.
 7.Support and provide leadership for data management staff for allocated trials.
 8.Freeze and lock data as appropriate in time for statistical review, blinded interim quality review, interim and final database lock. 
9.Perform training on data management software and practices or trial specific topics as required. 
10.Prepare training materials for data management activities and processes as required. 
11.Travel is required as needed

Minimum requirements 

University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant de-gree Fluent English (oral and written).
1.7 or more years experience in drug development with at least 4 years experience in Data Manage-ment.
2.University Science Degree in life sciences, phar-macy, nursing or equivalent relevant experience.
3.Excellent written and oral English skills
4.Understanding of clinical trial methodology, GCP and medical terminology
5.Good computer skills
6.Good organizational and project management skills. 7.Good communication and interpersonal skills 8.Intermediate presentation and problem solving skills 9.Ability to work well in a team 10.May coordinate and provide direction on task to other data management team members





Wednesday, 9 July 2014

Manager Client Services,1-2 years of Clinical Research Experience with MBA/ PGDM may apply @ Indegene Lifesystems Pvt. Ltd. - Bangalore D 10

Job description

Position Details : Manager Client Services

Designation : Manager Client Services

Experience : 0 to 2 years

Position Type : Full Time

Functional Area : Program management

Education : M.B.A/PGDM

Work Location : Bangalore

Job Description 
1. Should be responsible for delivery of projects on time and as per the quality expectations of the client

2. Strive to reduce turnaround time on an ongoing basis

3. Liaise and facilitate transfer of information between clients, business development teams, and delivery teams, in accordance with the established guidelines/processes/documentations

4. Assist the sales team in acquiring key orders or accounts by way of proposal development, on-/off-site presentations, etc.

5. Train and develop teams for projects as required 

Desired Profile 

1. Minimum 3 to 6 years of experience in pharmaceutical companies

2. Experience in any of the following functions: medical services/medico-marketing/health care/project management (preferred)

3. Strong people management skills

4. Strong written and verbal communication/presentation skills

5. Passion for networking

6. Keeping updated with the latest technical/scientific developments and relating them to various projects



Soft Skills 

· Client focus

· Result orientation

· Communicating with Impact

· Team player

· Process oriented




Experienced Clinical Research Professionals with minimum 2 years of experience (MD/M Pharm/ MBBS/ BAMS/BHMS) can apply, D9

Job description

Qualification: MD (Any stream)/ M Pharm or MBBS / BAMS / BHMS (With additional qualification in clinical research and professional experience as mentioned below)

Experience: Min 2-3 years’ experience as a Medical advisor with a medical communication agency OR strategic medical marketing role with a pharmaceutical company

Profile:

- Literature search on scientific and public domains

- Understanding the therapy area and appropriate communication points.

- Conceptualize, lead, plan and develop medical communication strategies across therapy areas for various clients and brands.

- Working with the team of medical writers to generate & review content for use of marketing communications such as - Product manuals, Visual aids, LBL, Monographs and other medico-marketing literature.

- Assist the BD team in winning pitches and business accounts through scientific participation. Work on creating scientific products that can provide impetus for the BD team to source growth.

- Provide foundational content development for consulting medical authors

- Proof reading and ensuring final check points for all materials.

Additional responsibilities:

- Single check point for quality, authenticity and accuracy of all data.

- Understanding of client requirements and managing deadlines with minimal or no reverts

- Collaborate efforts with academic faculty as needed in the design and development of continuing education content

- Mentor and guide the medical writers and other appropriate content department personnel

- Provide copy editing and medical editing of content developed by writers as needed

- Participate in the development of needs assessments

Other requirements:

- Ability to develop quality medical and technical content as required by the Company

- Ability to complete literature review and review/analyze scientific/medical research in order to apply knowledge to content development or medical editing

- Excellent command of the English written language, including grammar, punctuation, etc

- Possess analytical skills to assimilate and summarize complex scientific and technical data

- Current knowledge of the health care industry

- Good leadership and mentoring skills

Interested candidates may share their resumes with following details:

Apply online



Experienced Pharmacovigilance required, Medical Safety Officer @ iMED Global Corporation, Bangalore, D8

Job description

Under the oversight and delegation from the Medical Safety Officer (MSO) for Monograph Drugs, Devices and Cosmetics, this position develops the strategy and oversees the execution of the pharmacovigilance activities for allocated medicinal, device and cosmetic products and provides recommendation for risk management activities and their execution if necessary.
The MSO owns the post‐marketing safety surveillance plans for allocated products, collaborates with
matrix teams from other client functions and licensing partners on assessment of safety issues and
makes recommendations on actions required to maintain a positive benefit/risk profile of their
products.
The incumbent is responsible for placing safety profile into appropriate scientific and
medical context and be able to present the safety and benefit‐risk profile of the assigned portfolio of
products to key internal and external business partners and health authorities.
The MSO oversees development of safety elements of core labeling, provides medical input into
aggregate reports safety data assessments and ad‐hoc responses to safety questions from regulatory
agencies.

Desired Skills and Experience

Experience in aggregate reports & signal detection
Ability to triage safety information and escalate if appropriate to senior management
Strategy for safety and risk benefit assessment for assigned products.
Recommendations for safety related actions and risk management activities as required.
Represent Office of Consumer Medical Safety on Global Safety Review Group (GSRG),
Labelling Working Group (LWG) and present of safety information to senior management
Review and signatory for safety assessment documents for assigned products.
Interactions with regulatory authorities.
Work planning and assignment within a matrix team
 MBBS / M.D / BDS / M Pharm / Pharm D Required.
4‐5+ years in pharmaceutical, device and/or cosmetic and personal product medicine,
including safety
A sound knowledge of regulatory requirements for pharmacovigilance globally.
Good communication skills, both written and verbal.

About the Company:

MEDGlobal is an innovation driven company providing platforms, services and solutions to global life sciences clients addressing their critical business and scientific needs. Our platforms, services and solutions include Pharmacovigilance, Regulatory Affairs and Clinical Research. Led by a strong management team, with decades of experience and thought leadership with leading pharmaceutical, biotech, medical devices, cosmetic and technology enterprises, iMEDGlobal is designed to deliver high quality and cost effective solutions and services for our clients in the Americas, Europe, Asia and Australia. iMEDGlobal is a preferred partner to major life sciences companies with global presence who have placed their trust in the management, team, infrastructure and capabilities of the company.

At iMEDGlobal we consider our people as the single most important asset. 







Candidates with 1 year Experience may apply for post of " Investigator Payment Specialist @ Paraxel, Hyderabad D7

Job description


At PAREXEL, we have a passion for making a profound difference. As an expertise-based business, the caliber of our people and their dedication directly impacts our success, the success of our clients, and the ability to make a difference in the lives of patients worldwide. You'll be surrounded by supportive leadership and a brilliant team who share a common goal — to improve the lives of millions of patients.

Job Description 

Working independently and reliably showing a high level of ownership, with a strong focus on detail and committed to the Collection, qualitative data entry, for invoices related to the Investigators. Assist the IPO leads in their project planning, and payments to Investigators. As a strong team player the Payment Specialist should be able to communicate with various internal and external functions.

Qualifications 

Candidates with 1-2 years of relevant experience involving qualitative data entry/ data validation accounting, finance/ Project Management/ Contracts, and should be proficient in use of web based IT systems and MS Excel, PowerPoint, MS Project and Word. Freshers & college interns also can be considered.

Apply Directly on Company Website.


Sceince / Pharmacy / Nursing Graduates opportunity for Vacancy as Drug Safety Associate/ DSA, @ ICON PLC, Chennai D6

Job description


Drug Safety Associate,
Chennai, India.

ICON is growing! ICON Clinical Research is a global leader, providing drug development services to the pharmaceutical; biotechnology; and medical device industries. Due to new business wins we are currently looking to recruit a number of Drug Safety Associate’s (DSA’s) to join the existing team within the Medical & Safety Services department.

Overview of the Role
  • Your primary responsibility will be validating and quality checking safety database fields on assigned projects.
  • You will also provide input for and review relevant safety tracking systems for accuracy/quality and perform safety review of clinical data (case report forms) and patient labs.
  • You will also be responsible for documenting and processing serious adverse event cases within ICON, regulatory authorities and sponsor regulations and time frames.

Role Requirements
  • With a science degree, pharmacy or nursing background or equivalent, you will have previous experience in a drug safety environment together with strong knowledge of medical terminology.
  • You will have knowledge of drug safety databases, preferably ARGUS.
  • You will have the ability to produce high quality work, with meticulous attention to detail.
  • You will be fluent in verbal and written English, with excellent communication skills.

Benefits of Working in ICON

Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.

We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.

What’s Next?

Following your application you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity.

ICON is an equal opportunity employer – M/F/D/V and committed to providing a workplace free of any discrimination or harassment.

Manager Medical Writing required vacancy @ Indigene, Banglore, D 5

Job description

Position Details : Manager Medical Writing

Designation : Manager Medical Writing

Experience : 3 to 5 years

Position Type : Full Time

Functional Area : Scientific Content

Education : B.D.S, MBBS, Ph.D

Work Location : Bangalore

Job Description 

1. Should be accountable for the quality, implementation, and timeliness of medical writing
deliverables, including clinical study reports (phases I–IV), clinical study protocols,
safety narratives, investigational drug brochures, summaries of efficacy and safety,
PSURs, scientific manuscripts, and abstracts

2. Work and interact extensively with clinical and regulatory experts, biostatisticians
as well as external contacts to ensure high quality with regard to scientific
content, organization, clarity, accuracy, format, and adherence to regulatory
and internal guidelines, styles, and processes

3. Provide guidance and support to all team members on a project with
regard to format, style,content, and compliance

4. Ensure that clinical documents adhere to current global standards,
FDA, ICH, and GCP guidelines and are in accordance with
electronic publishing standards

5. Guide and mentor team members to ensure consistency and completeness
of the project

6. Provide peer review for colleagues' documents

7. Create, maintain, and disseminate medical writing training materials and
guidelines, and conduct training seminars as necessary

8. Write SOPs and/or review them for completeness and updates as needed

9. Review and write clinical proposals and project status report

Desired Profile
1. Able to demonstrate thorough knowledge of FDA, ICH, and GCP
guidelines regarding thesubmission of documents in accordance
with current regulatory standards

2. Must have proven experience (minimum 4–5 years) as a scientific medical
writer in a clinical research environment and proven experience in the
management of medical documentation

Soft Skills 

· Client focus

· Result orientation

· Communicating with Impact

· Team player

· Process oriented

Start up Specialist required at Roche, Mumbai Freshers may apply but experience will be given preference. D4

Job description

About Roche

At Roche, 85,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

The Position
  • Coordinate guide and assist with all start up activities prior to site activation
  • Maintain up to date knowledge, ensure adherence and compliance with regulatory requirements and related documentation
  • Liaise and collaborate with relevant authorities/bodies to further enhance critical trial processes, government policies/laws, via innovative approaches
  • Assist with identification and tracking of new sites in collaboration with CSMs
  • Provide expertise and guidance to Local Study Team (LST) for identification, creation and implementation of specific recruitment/retention tactics & contingency planning
  • Negotiate contracts and study budgets with sites during the study start-up phase to ensure finalization

  • Who you are

    You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.

    • University degree or equivalent in medical/science related field
    • Prior work experience demonstrating knowledge and understanding of clinical trials
    • Demonstrated knowledge and understanding of ICH-GCP, the regulatory, ethics and contractual requirements for starting clinical trials in relevant country
    • Demonstrated competence in analysis, planning and problem solving
    • Proven project management and organizational skills and the ability to prioritize and manage multiple tasks with flexibility
    • Demonstrated computer literacy

    • The next step is yours. To apply today, click on the "Apply online" button below.

      Roche is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.

      Apply Online



Clinical Database Programmers required at Novartis, Up to 2 yrs of Experience can apply., D3

Job description

Job Description:
Develop and maintain trial specific database
applications, including either eCRFs and database specifications, in support of
in house and outsourced trials Program validation and derivation procedures of
various levels of complexity within the clinical database management system
(OC/RDC) using SQL or PL/SQL to support the development of trial specific
database applications globally for Phase I-IV with supervision. Develop the eCRF
layout and corresponding database according to documented trial specific
requirements using components from existing libraries Create, test and maintain
trial specific plausibility and consistency checks Provide data transfer
specifications for third party data Maintain and update the eCRF application and
its components as required for protocol amendments or required post production
changes Develop database specifications and provide support for outsourced
trials Create, file and maintain appropriate trial documentation Program and
test complex procedures, from documented trial specific requirements, within the
clinical database management system using SQL or PL/SQL Maintain and update
procedures as required for protocol amendments or required post production
changes Creation & execution of trial design reports based on trial metadata
Understanding of Novartis Clinical Data Standards for procedures
development

Desired Skills and Experience

Minimum requirements:
University or college degree in Life Sciences, Mathematics, Computer Science, Medical Informatics, or equivalent degree Fluent English (oral and written). At least 2-3 years experience in clinical database programming, setup of clinical databases and CRF design, and procedure /validation programming, as part of the setup of clinical databases, gained in the pharmaceutical industry, CRO or Life science related industry as well as the following: • Strong knowledge of SQL or basic knowledge of PL/SQL • OC/RDC experience preferred • Understanding of clinical data management systems and/or relational databases as applied to clinical trials • Attention to detail, quality, time management and customer focus. • Ability to translate technical concepts for non-technical users in the areas of clinical database design and procedure development • Strong verbal and written communication skills to work with our global partners and customers



Image Analysis Research Scientist, vacancy in GE India, Bangalore, D2

Job description

About GE 

GE goes beyond geographical and technology boundaries. Over time, we have developed world-class research facilities across the globe and tapped into global technical talents to bring technology development closer to the people across the globe and improve the life. We have 2,500 researchers across the world working together to bring new technologies to all of the GE businesses. From United States to Europe to India and China, our world-class facilities create the breakthroughs for the next generation of GE products and services. The John F. Welch Technology Center, Bangalore, is General Electric's first and largest Research and Development Centre outside the US. An integral part of GE Global Research, the US $80 million infrastructure at John F. Welch Technology Center is a hub of technology, research and innovation for GE worldwide. The focus of the Center is to enable the growth of GE businesses through innovation and the use of cutting edge technologies. GE Global Research is an Equal Opportunity Employer. The Medical Image Analysis Lab, located in the John F Welch technology Center and a part of GE Global Research, is focused on development of new algorithms for CT, MRI, PET, XRay and multi-modality image analysis for detection, registration, characterization, motion management & image quality improvement.

Relocation Expenses
Yes

Role Summary/Purpose
We are looking for highly motivated researchers to conduct research in medical image analysis for imaging modalities CT, MRI, PET & build solutions to address varied clinical problems. The person should have strong interest in clinical systems & sound knowledge to work towards improving diagnostics & biomarker discovery in the areas of neurology, oncology & cardiology. He/She is expected to be exceptional in formulating image/signal analysis algorithms, implementation & validation.

Essential Responsibilities
This role requires scientist with proven expertise in medical image analysis through top-notch publications and experience of working with clinicians & experts and building innovative technology solutions addressing different clinical problems. In particular the individual is expected to conduct research in image analysis (including registration and multi-modal analysis) for building new solutions in the areas of neurology, cardiology & oncology. The person is expected to possess strong background in solving optimization problems in the area of medical image/signal analysis, with a strong understanding of the clinical process and workflow. This has to be supported through a proven track record of high quality publications. He/She needs to have strong background in mathematical formulation & implementation and programming skills. He/She should be able to work global multi-disciplinary teams, with clinical partners, being able to understand disease space and subsequent modality requirements.

Qualifications/Requirements
We are looking for candidates with PhD in Electrical Engineering, Computer Sciences, Physics, Biomedical Engineering or Applied Maths having an outstanding track record of publications and demonstrated ability to learn recent advances in medical image analysis or applied mathematics. The individual should have also a proven aptitude of developing lateral & innovative solutions with strong understanding of the physics & mathematical constructs. He/She must be eager to publish in high quality conferences & journals and also work in a global team of experienced and dynamic researches to develop the next generation of imaging. Should be a team player with good communication skills.

Desired Characteristics
Candidates should have a strong physics orientation, understanding of mathematical concepts & formulations with desirably good C/C++ skills, and familiarity of open source tool kits.

Vacancy for the Research Scientist M. Pharma @ Fresenius Kabi , D1

Job Title :Research Scientist

Department : Formulation Development

Educational Qualification : M.Pharma in Pharmaceutics from a reputed university

Experience : 2-3 years of experience in generic formulation development of injectables for regulated markets(US/EU/Japan) from reputed company

Location : Gurgaon

Description 

RESPONSIBILITIES:Planning, coordination and execution of product development activity for global markets.
Evaluation of literature and patents related to products under development.
Planning of stability studies and reviewing of development and stability data.
Compilation of Technology Transfer Dossier related documents.
Scale-up and technology transfer of products to manufacturing locations.

TECHNICAL EXPERIENCE:Handling of Para IV ANDA products for US market.
Good understanding of regulatory requirements of global markets.
Good understanding of Patent and IPR strategies.
Execution of exhibit batches and technology transfers to manufacturing locations.

PERSONAL ATTRIBUTES:Commitment, ownership, integrity, adherence to time lines.
Should have good planning and organizing capabilities.
Should be self motivated and having positive attitude.
Should have good drafting and communication skills.
Should have good team spirit.

Apply to the company Website




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