Friday, 24 April 2015

Senior Medical Writer-Cactus Communications Pvt. Ltd. -Mumbai

Job Description

 
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    The Medical Writing team at Cactus offers medical writing services to multinational pharma, clinical research organizations, and researchers worldwide. We work with clinicians and researchers to help them communicate their science to the world. We are currently looking to add to our team of medical writers, experienced researchers, preferably post docs looking to work in non-lab setting, aspire to be part of a world-class delivery team, and work in an exciting, fast-paced global environment. Visit http://www.cactusmed.com (USA) or http://www.cactusglobal.com (India) for further details.

    What is a typical day at work like?


    • Ensure timely production of high quality documents (manuscripts, abstracts, short communications, review articles) for publications in journals or for presentation in meetings and other written communication material supporting pharmaceutical brands, research activities, and business needs
    • Prepare documents that are publication ready
    • Review work done by team members and provide appropriate feedback
    • Liaise with internal and external stakeholders, including authors & KOLs
    • Act as document specialist and provide intellectual input across document types
    • Provide quality-related coaching or mentoring to team members, as appropriate
    • Develop and maintain necessary templates, formats and styles to ensure that documents generated meet industry, internal, and client requirements
     

    APPLY HERE

Medical Writing - Trainee ( Fresher )-Quintiles -Bengaluru/Bangalore

Job Description

 
 PURPOSE
Assists senior medical writing staff in the preparation of study reports, submissions, or other documents for either internal Quintiles customers or external clients, for investigational drugs, biologicals, or medical devices. Participates in project teams and may lead specific straightforward or small tasks, consulting senior staff as necessary.

RESPONSIBILITIES

Supports Medical Writing senior staff in managing client requests. Examples include but are not limited to the following: writing patient narratives, straightforward bioanalytical study data reports, checking document edits, checking documents for consistency, adapting generic document shells to project specifications, assisting with document compilation, and entering numbers into in-text tables. May also draft text for simple documents, reports or sections of documents or reports, with guidance of senior staff.
Identifies project needs, tracks project timelines and implements client requests, with senior review.
Interacts with internal clients. May have some external interactions, mostly directed by senior staff.
Takes responsibility for managing day-to-day workload for assigned tasks, in collaboration with senior staff.
Keeps abreast of current data, trends, medical and/or technical writing/regulatory knowledge, developments and advances in area of drug development/medical and/or technical writing.
Complies with Company SOPs and participates in the implementation of new SOPs.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

Excellent standard of written English, and ability to communicate fluently and effectively in English, both in writing and verbally.
Ability to work on several projects at once while balancing multiple and overlapping timelines.
Ability to assess workload and suggest prioritization to senior staff.
Demonstrated abilities in collaboration with others and independent thought.
Knowledge of regulations relevant to medical/technical writing, such as Good Laboratory Practices (GLP) and other relevant regulatory agencies (e.g. OECD, MHLW).
Careful attention to detail and accuracy.
Must be computer literate.
Ability to establish and maintain effective working relationships with coworkers, managers and clients.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

Dentistry / BHAMS / M-Pharm with post-graduation in clinical research.Bachelors degree in a life science-related discipline, communications, technical writing, or related field; or equivalent combination of education, training and experience. FRESHER

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Do your certification in this summer....Apply for it..get employed into Drug Development industry

Thursday, 23 April 2015

Indian Biosimilars Market

India is one of the biggest sources of generic industry and is one of the emerging markets with its high population and investment in technology. Although India does not have stringent regulations, the country has a big potential for biosimilars… 
If we have a look at the sales figures of Indian biosimilars, 200 million US dollars of sales was recorded in 2008. But according to the analysts, the market will grow to 580 mUSD in 2012, which means a CAGR +30%.
REGISTRATION OF BIOSIMILARS
As described, India is a semi-regulated market and no phase I/II studies are required for biosimilars. To conduct a phase III study is a mandatory step and minimum 100 patients are needed for this study.
Due to the legislation and the environment in the country, the development of a biosimilar can be between 10-20 mUSD in India, much cheaper than the fully regulated countries. And with this regard, the price of a biosimilar, can be 25-40% cheaper than the originator.

Read More

Advanced drug delivery systems: Nanotechnology of health design A review

Nanotechnology has finally and firmly entered the realm of drug delivery. Performances of intelligent drug delivery systems are continuously improved with the purpose to maximize therapeutic activity and to minimize undesirable side-effects. This review describes the advanced drug delivery systems based on micelles, polymeric nanoparticles, and dendrimers. Polymeric carbon nanotubes and many others demonstrate a broad variety of useful properties. This review emphasizes the main requirements for developing new nanotech-nology-based drug delivery systems.

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Research Coordinator-LV PRASAD EYE INSTITUTE -Hyderabad / Secunderabad

CTC: 2,50,000 - 3,75,000 P.A 

Job Description

 

1. Prepares study materials including ethical committee or regulatory submission documents, enrollment logs, adverse event reports, and staff training materials.
2. May assist in recruitment, training and supervision of research staff.
3. All communications related to project with partners and funding agencies.
4. Prepare reports financial, project progress etc.
5. Arrange, organize, communicate and prepare minutes of research group.
6. The project involves conducting workshops. It will involve arranging venue, communicating with participants, travel and lodging arrangements etc.
7. Maintaining all study files.
8. Back up of all E-research data.
9. Internal communicates- finance, progress reports; publication etc.

Desired Candidate Profile

Education-
UG: B.Pharma - Pharmacy
PG:M.Pharma - Pharmacy

APPLY HERE


HOS Data Entry-any Grad-Accenture-Chennai

Job Description
Schedule : Full-time

Responsible for the review and validation of eligibility information received from the customer as well as the data-entering of this information into the client system.
Responsibilities/Authorities :

? Complete review of enrollment forms
? Identify missing information on forms
? Send incomplete forms back to client
? Complete and forward outgoing correspondence when required
? Key enrollment forms into client eligibility system
? Maintain customer eligibility information
? Review and analyze specific eligibility report
? Maintain and track individual workflow and production
? Support inventory control during peak times or as needed
? Processes faxed eligibility maintenance requests initiated by Customer Calls
? Process urgent requests
Requirements:
? University degree or equivalent.
? At least 6 months experience as a Processing Assistant preferred, but not required
? Outsourcing operations experience preferred, but not required
? Working knowledge and experience with computers and internet
? Technical or Specific Skills (e.g. technical, computer)
? Basic technical knowledge
? A working knowledge of MS Office products
? Proficient in report writing, business correspondence
? Strong Excel skills

Mandatory Requirement

1. At least 6 to 12 months work experience in healthcare domain as per required domain
a. Claims
b. Billing Function
c. Enrollment
2. Should have past experience working in night shift
3. Should be open to working in night shift
4. Good English comprehension -- verbal and written
5. Simple analytical skills
6. Good typing skills, at least 30 wpm at 95% accuracy
7. Residence should be within Accenture Transport Boundary
8. Should at least be a graduate

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Clinical Research Associate-Manipal Acunova Ltd.-Bengaluru/Bangalore

Job Description

 
The responsibility of a Clinical Research Associate (CRA) is to perform all clinical monitoring aspects of designated projects in accordance with applicable SOP and regulations. Responsibilities include performing clinical on-site monitoring activities (drive patient recruitment, source data verification, drug accountability, and data collection), collecting regulatory documentation (when required), performing qualification, initiation, monitoring and termination of investigational sites in accordance with ICH GCP guidelines.

Preparation of Site feasibility questionnaire, conducting the feasibility and reporting to PM
Preparation, conduct and reporting of site selection visits
Negotiation & obtaining Investigator agreement on site budget, payment to the sites
Development/Local adaptation of study specific documents (ICF, CRF prints, Study logs), translations of the documents
Procuring essential documents from sites, their QC and filing in a timely manner and updating project tracker or sending the documents to PA for filing in a timely manner
Maintenance of TMF and Site specific file
Scanning & uploading documents into shared drive
Transmission of documentation into project files
Preparation of regulatory dossier, regulatory submission and follow-up.
Preparation of EC dossier, EC submissions and follow-up
Co-ordinating arrangements for the investigators meeting, acting as a host for this meeting
Development of meeting materials along with required presentations for investigators meeting.
Site initiation visit planning, preparation, conduct, report and follow-up of pending issues
Co-ordinating the IP request between sites and pharmacist/vendor/sponsor

Desired Candidate Profile

Education-
UG: B.Pharma - Pharmacy
PG:M.Pharma - Pharmacy
Doctorate:Any Doctorate - Any Specialization, Doctorate Not Required
    Worked in OPHTHALMOLOGY or ONCOLOGY or DIABETES studies Clinical Studies I-IV
    Ability to interact professionally with clients/vendors
    Excellent interpersonal, verbal and written communication skills and ability to work in a team
    Effective time management skills and prioritize tasks to manage study timelines
    Strong computer and internet skills including knowledge of MS-Office products such as Excel, Word etc, sound presentation skills
    Willing to travel a minimum of 65% on average

    APPLY HERE

Research / Clinical / Medical / Non Clinical / US Healthcare - 10 Opening(s)-Hyderabad / Secunderabad

ESSENTIAL JOB RESPONSIBILITIES:

Accurately responding to research related queries and proposing suggestions for rule changes if applicable.
Develop potential rules that can be applied for iHT clients to adjudicate claims accurately relative to medical policy. Review State Medicaid guidelines to identify possibility of inappropriate edits for Medicaid claims.

RELEVANT EXPERIENCE & EDUCATIONAL REQUIREMENTS

- Medical degree (MBBS or MD) / Certified medical coder / BHMS / BAMS
- Clinical experience is a must
- Clearance of all major exams (SSC, HSC, qualifying degree) in first attempt
- Clearance of cognitive aptitude test analytical, quantitative, and logical reasoning skills
- Experience in private sector/ Health plan operations with focus on reimbursement and/or claims processing and/or medical coding preferred
- Knowledge of ICD-10 coding preferred 

Contact Person: Mohsin

APPLY HERE

Apply For Summer Internship....

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Wednesday, 22 April 2015

Start your Research and Development career now.....

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Submission Writer-Novartis Healthcare Pvt. Ltd. -Hyderabad / Secunderabad

Job Description

 
1. To author, review and independently manage high quality clinical and safety documents: non registration Clinical Study Reports (CSR), Development Safety Update Reports (DSUR), Clinical Trial Registry Database (CTRD), Risk Management Plans (RMP), Periodic Safety Update Reports (PSUR). 2. Lead for outsourced Narrative projects. Coordinate other outsourced activities in OSM. 3. Core member of Clinical Trial Team (CTT)/ participate in Safety Management Team (SMT). 4. Actively participate in planning of data analyses and presentation to be used in CSRs. 5. Act as documentation consultant in CTTs and SMTs to ensure compliance of documentation to internal company standards and external regulatory guidelines. 6. May act as Program Writer ensuring adequate medicalwriting resources are available for assigned program and consistency between documents. 7. Act as liaison between CTTs, CSTs and publishing teams to ensure timely delivery of final documents for publishing. 8. Support the development of OSM through participating in OSM initiatives and other related activities. 9. Contribute to development of processes within OSM. May contribute to cross-functional initiatives. 10. Fostering cross-functional communication to optimize feed-back and input towards high quality documents. 11. Maintain audit, SOP and training compliance.

Minimum university life science degree or equivalent is required. Advanced degree or equivalent education/degree in life sciences/healthcare is desirable. Fluent English (oral and written). HYDERABAD ONLY: Masters with 3-5 years of relevant experience. PhD or degree in medicine (MBBS/MD or Alternative medicine) with 1-3 years of relevant experience 2 years medicalwriting experience or other relevant pharma industry experience combined with scientific and regulatory knowledge, plus strong knowledge of the medicalwriting processes. Excellent communication skills (written, verbal, presentations) Operational knowledge of clinical trial reporting. Very good understanding of biostatistics principles. Ability to prioritize and manage multiple demands and projects. Good knowledge of and some experience in global regulatory environment and process (key regulatory bodies, key documents, approval processes, safety reporting requirements). Ability to define and solve complex problems (Problem-solver) Broad knowledge and future oriented perspective Proven track record in matrix environment Experience in contributing to global, cross functional projects.

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Document Review Team Lead-Bengaluru/Bangalore, Mumbai, Delhi-PPD

Job Description
Due to continued growth, PPD is recruiting for a Document Review Team Lead to join our Global Medical Writing team.

Responsibilities:

Supervises the overall operational activities of project(s) within the Document Review group including but not limited to: Provide short-term and long-term resource planning in order to assign project activities to appropriate and available staff. Hold regularly scheduled meetings with staff and provide updates to senior management. Assist staff to forecast project-related timelines for completion. Hires and evaluates employees. Recommends salary levels and promotions.

Oversees the preparation of Document Review deliverables and may serve as lead reviewer on large review projects. Organizes processes for completion of projects within established timelines. Evaluate timeliness and quality of deliverables and provide updates to senior management. Provide input and review group SOPs and WPDs; evaluates compliance with SOP/WPD on an ongoing basis. Builds client relationships, identifies, and resolves complex client management issues.

May support marketing presentations to potential clients on the capabilities of the Document Review group.
Provides input on training programs for Document Review. Ensures that reviewers on assigned project are adequately trained in document review skills.

Qualification Required:

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3+ years) or equivalent and relevant combination of education, training, & experience.
1+ year of leadership responsibility

Knowledge, Skills & Abilities:

Experience mentoring personnel and coordinating the work of project teams
Ability to supervise, evaluate, and mentor departmental personnel
Ability to delegate tasks and facilitate completion of assignments
Effective management skills, including the ability to create and modify budgets, project timelines, allocate resources, and forecast departmental workload
Demonstrated innovation in developing new ideas related to process improvements
Strong document and quality review knowledge
Proficient in Microsoft (MS) Word and MS Excel
Advanced organizational, analytical and interpersonal skills to manage several complex projects in parallel and manage rapidly changing priorities
Ability to independently assess client needs and work with project team members in producing compliant deliverables
Ability to independently learn new technologies
Advanced editorial/proofreading skills
Strong leadership to a diverse staff
Ability to work on extremely complex problems where analysis of situations or data requires an evaluation of intangible variables
Ability to exercise independent judgment in developing methods, techniques, and evaluation criteria for obtaining results


Desired Profile

Education:UG -Any Graduate - Any Specialization, Graduation Not Required
PG - Any Postgraduate - Any Specialization, M.Sc - Any Specialization, Chemistry, Biology, Statistics, M.Pharma - Pharmacy

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H and LS Medical Writer- 4 - 6 YearsChennai-Accenture

Job Description Schedule : Full-time

Ph.D. in Life Sciences or Pharmacy/M.D. in Pharmacology or Physiology or Public Health/ M.B.B.S./ B.D.S./ B.A.M.S with 4 to 6 years of experience in clinical development including supporting/ leading activities related to reconciling, writing, editing and/or managing the production of high quality clinical documents that are components of regulatory marketing approval may apply.


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Walk-in @ Quintiles for PV on 25-apr-2015(fresher & Experienced)-Bengaluru/Bangalore

Job Description

 
Hi,

Greetings from Quintiles!!!

We are hiring candidates for Pharmacovigilance Positions.

Its an exclusive walk-in event for both freshers and experienced on Saturday, 25th Apr 2015.

Timings: 8:00 AM
Interview Venue Details
Quintiles Research India Pvt Ltd.
Prestige Technologies Park ll,
Etamin Block, 3rd floor, B-wing,
Sarjapur-Marathalli Outer Ring Road,
Bangalore-560 103
Landmark: J.P Morgan company, same campus last block
Contact: Shamshuddin/Kavya L
Requirement : Candidates only with Life Science background with good knowledge in Pharmacovigilance can apply.

RESPONSIBILITIES
To Prioritize and complete the assigned trainings on time.
Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.
To perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming Adverse Events(AE)/endpoint information; determining initial/update status of incoming events; database entry; coding AE and Products, writing narratives, Literature related activities.
Assuming other workflow responsibilities for the assigned project as directed by Operations team member or Manager.
Ensure to meet the expected productivity and quality standards
Ability to identify quality problems, if any, and bring them to the attention of a senior team member/ mentor.
Attend project team meetings and provide feedback to operations manager on any challenges/issues or successes.
Perform other duties as assigned.

Desired Candidate Profile

Education-
UG: B.Sc - Any Specialization, Any Specialization, Any Specialization, B.Pharma - Pharmacy, Pharmacy, Pharmacy, BDS - Dentistry, Dentistry, Dentistry
PG:Post Graduation Not Required, M.Sc - Any Specialization, Anthropology, Bio-Chemistry, Biology, Botany, Nursing, Zoology, Other, M.Pharma - Pharmacy, M.Tech - Any Specialization, Bio-Chemistry/Bio-Technology, Biomedical

Pharmacovigilance Practice Head - IMS Health-Bengaluru/Bangalore, Gurgaon

Job Description

 
    Role Purpose:

    Grow and manage the pharmacovigilance (PV) services delivery practice at IMS Healths Global Delivery Center (across Bangalore, Gurgaon, and Colombo offices)

    Principal Accountabilities:

    Enable pharmacovigilance/adverse events tracking (PV/AE) business deals by supporting the onshore teams in the sales cycle, through building/enhancing suitable collateral for the practice, including pitch decks, proposals, project plans, audit plans, SOPs, etc.
    Manage the PV team across different locations
    Liaise with technology team to drive the PV/AE engagements successfully, and leverage automation to enhance productivity as well as quality
    Ensure all projects are managed with pristine quality, and within the timelines agreed upon
    Drive operational excellence in the PV practice, and streamline PV processes
    Drive the culture of metrics and reporting these on a periodic basis, to enhance the quality and operational rigor of the practice
    Ensure rigor in documentation and establish best practices
    Track resourcing and profitability on engagements
    Prepare the team for pharma company PV audits and to successfully undergo these audits
    Establish processes for training as well as certifications required for the PV practice
    Hire smart candidates (fitness for purpose) and groom them
    Drive productivity, smart processes, and policies
    Drive thought leadership and innovation 
Minimum Education, Experience & Specialized Knowledge Required:

Educational requirements Life Sciences degree, preferably B.Pharm + M.Pharm (or B.Pharm + MBA), or MBBS from a reputed institute, with respectable scores throughout the academic career
10+ years of experience in pharmacovigilance (post-marketing surveillance experience is highly necessary as opposed to AE tracking in clinical trials)
Experience in both agency/vendor/partner (must-have) and pharma (good-to-have) preferred
Experience of driving the preparation for audits, and successfully undergoing stringent audits by pharma companies as a PV agency/partner to a pharma company
Training certifications in pharmacovigilance/adverse events tracking
Excellent communication skills
Experience in onshore/offshore model preferred
Knowledge of and exposure to unstructured data/social media data would be a plus
High comfort level and affinity to using technology tools in the field of adverse events tracking
Drive for excellence in work, passion for quality, ability to operate at scale without compromising quality, team building and leadership abilities
Social adaptability, willingness to adapt to international cultures, work environments and business processes

Additional Requirements:

Excellent presentation skills
Drive for perfection, strong attention to detail, and impeccability in delivering publishable output
Ability to communicate effectively in a complex global business set up since the job will involve routine interaction with international stakeholders
The candidate should be willing to go through assessment tests and series of interviews, which are, as a practice, administered for recruitment across all levels (including senior-most) in the Nexxus Social Media team, of which the PV team is an integral part.

APPLY HERE

     

Clinical Research Coordinator TECH OBSERVER 1 - 2 yrs Mumbai

CTC: 1,25,000 - 1,50,000 P.A
Job Description

Recruitment,coordination & follow up of trial subjects, covering informed consent, adhering to safety and compliance issues;sample collection & shipment;Administer study drug;Coordination & management of Clinical Trial;

Salary: 1,25,000 - 1,50,000 P.A

Role Category:R&D

Role:Clinical Research Associate/Scientist

Desired Candidate Profile

Education-

UG: B.Pharma - Pharmacy, B.Sc - Any Specialization

PG:Post Graduation Not Required, M.Pharma - Pharmacy, M.Sc - Any Specialization

Doctorate:Any Doctorate - Any Specialization, Doctorate Not Required

    Good Communication skills
    Willing to travel within City

APPLY HERE

Walkin - in Interview in Quintiles on 25th April 2015 Quintiles -2 - 7 yrs Bengaluru/Bangalore

 

CTC: 2,00,000 - 7,00,000 P.A 

Job Description

 
     Walk-in Interview in Quintiles on 25th April 2015.

    Desired Profile :

    Candidates with experience from 2 to 7 years in Clinical Research /CRC / CPC / CTA /Lab/ Clinical trails  are welcome.
    Excellent Communication skill is mandatory.
    Willing to work in shift.



    Venue Details
    Wing A, GroundFloor, Etamin Block,
    Prestige Technology Park II
    Sarjapur  Marathahalli, Outer Ring Road,
    Bangalore - 560103.
    Contact Person: Sudhamani/Thenmozhi
    Time : 8.00AM

     
Salary: 2,00,000 - 7,00,000 P.A
Role:Clinical Research Associate/Scientist

Desired Candidate Profile

Education-
UG: Any Graduate - Any Specialization, Graduation Not Required
PG:Any Postgraduate - Any Specialization, Post Graduation Not Required
Doctorate:Any Doctorate - Any Specialization, Doctorate Not Required

Get knowledge and experience together-Get Employed with CRO, Bio-pharma and IT Life Science Org.

https://docs.google.com/forms/d/17B1o8qnDipYPw5gpaNaKygwPG37rGuVb9ZxI7Yny4qA/viewform