Organises and analyses compliance data for safety information exchange
with global license partners and provides root cause analyses for
individual cases submitted late to authorities and other non-compliance
with global pharmacovigilance agreements. 2.
Reconciliation - ensures regular reconciliation of exchanged reports
between Novartis & global licensing parties is performed &
documented. Communicates any reconciliation issues to PAM, PAH and PPV
Head and liaises with PAM to resolve internally and with the license
partners. 3. Authors monthly compliance and reconciliation reports,
including trend-analyses, for exchange of individual case reports, and
other written safety documents between global licensing parties, for
both incoming and outgoing information. 4. Alerts PAM; PAH and PPV Head,
EU-QPPV and DS&E Operations Management of compliance and
reconciliation issues and liaises with PAM, PAH, global operations,
DS&E management and license partners to ensure that corrective
actions proposed and implemented by the operations groups / license
partners are appropriate and effective to improve and maintain a high
level of compliance. 5. Argus configuration - regularly reviews
expediting requirements and organises verification of corresponding
Argus configuration in collaboration with PV-SDM and PAM, as required.
6. Pharmacovigilance agreement updates updates and maintains with PAM, global pharmacovigilance agreements as required.
Tuesday, 28 April 2015
Monday, 27 April 2015
Opening for Medical Review/chennai
Hiring for Medical Review
Location Chennai
MBBS /MD candidate.
2-2.5 yrs overall exp( Clinical practice + Medical Reviewer/Clinical Research/PV)
Open to work in Pharma shifts
2-2.5 yrs overall exp( Clinical practice + Medical Reviewer/Clinical Research/PV)
Open to work in Pharma shifts
Interested candidates can send there resume for support@theverticalrecruiters.in
or can call me at 9582647399 Ankit
ctc: 5,00,000 - 8,50,000 P.A
Wanted B.pharmacy & M.pharmacy Freshers for Meddra & WHO DD Coders-Clincorp Technologies Private Limited-Hyderabad / Secunderabad
-
Graduates & Postgraduates in Pharmacy with 0 to 3 years of working
knowledge in encoding Serious Adverse Events information according to
Medical standards may apply. Experience with MedDRA and WHODD coding
standards is a prerequisite.
Desired Candidate Profile
Education-
UG: B.Pharma - Pharmacy, BDS - Dentistry, MBBS - Medicine, BHM - Hotel ManagementPG:M.Pharma - Pharmacy, M.S/M.D - Any Specialization, Cardiology, Dermatology, ENT, General Practitioner, Gyneocology, Hepatology, Immunology, Microbiology, Neonatal, Nephrology, Urology, Obstretrics, Oncology, Opthalmology, Orthopaedic, Pathology, Pediatrics, Psychiatry, psychology, Radiology, Rheumatology, MVSC - Veterinary Science, PG Diploma - Any Specialization
APPLY HERE
Walk-in Interviews for Advanced/senior Associates-non-voice Process!!!-
Job Description:
Xchanging is conducting, Walk-in interviews from Monday 27th April 2015 to Thursday 30th April 2015 for its Healthcare Business , BPO division -Whitefield Bangalore. Interview Timing : 10:00 AM to 1:00 PM
Contact Person : Carol Fernandes
"Carry a copy of this ad along with your CV."
Interview Venue :
Xchanging
Xchanging Towers, SJR I-Park,
EPIP Area, Whitefield, Opp Satya Sai Hospital,
Bangalore - 560066. India.
The candidate is accountable for :
Need to create orders for the Injured Patients.
Understand the different body parts and creating the orders without any defects.
Ensuring the right interpretation is done based on the prescription, which we are receiving from the Doctor/Hospitals.
Ability to record patient observations accurately and report any issues or concerns immediately to the TL.
Typing speed of minimum 35 WPM.
Preferred Candidate Profile
Excellent Communication Skills
Voice Process, making outbound calls.
Should be able to work under unpredictable circumstances.
Requisites
Degree in B.Sc.(Biology)or Candidates with Health Care work experience.
Experience with International voice process.
Willing to work in global shifts
Walkin - in Interview in Chennai on 9th MAY 2015( Job Loc'n: Blore)-Quintiles
CTC: 2,00,000 - 7,00,000 P.A
QUINTILES Walk - in interview in CHENNAI Location on 9th May 2015 (position based out of Bangalore)
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.
Interview Venue Details
The Pride Hotel, 216, EVR Periyar Salai, Kilpauk, Chennai - 600 010.
Contact Person: Kikali/Thenmozhi/Padma
Time : 8.00AM
QUINTILES Walk - in interview in CHENNAI Location on 9th May 2015 (position based out of Bangalore)
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.
Interview Venue Details
The Pride Hotel, 216, EVR Periyar Salai, Kilpauk, Chennai - 600 010.
Contact Person: Kikali/Thenmozhi/Padma
Time : 8.00AM
Clinical Research Associate- Clinical Research Associate-Navi Mumbai, Ahmedabad
Job Responsibilities:
Conduct Site Initiation Visits (SIV), conduct Protocol, ICH-GCP and SOP training at sites, demonstrate study procedures including Source Templates Filing, Annotated CRFs & CRF filling instructions (Paper/EDC), Informed Consent procedures, Patient Screening & Eligibility procedures, IP Handling procedures, Safety Reporting & Unblinding procedures etc. to investigators and CRCs, ensure timely SIV reporting & follow-up letters
Conduct routine Site Monitoring Visits (SMV) to clinical sites, do Source Doc Verification, review Site Master Files (SMFs), relevant study and patient records, resolve open site issues, ensure timely SMV reporting and follow-up letters
Verify Clinical Supplies Inventory and IP Management procedures at site and ensure complete and accurate drug accountability
Ensure Protocol Compliance in execution of trials, identify, document and resolve protocol deviations and violations, informed consent deviations and issue/action log
Ensure compliance to ICH-GCP, Indian GCP / Schedule Y and other applicable regulatory standards
Review communication of site with IRB/EC and other regulatory bodies
Act as Lead Monitor, maintain contact with site personnel and ensure timely resolution for study specific queries as well as proper escalation of site/project related issues to sponsor
Maintain audit readiness at the site level for any audits or regulatory inspections
Conduct site/study close-out activities and assure appropriate archival of controlled documents and retrieval of CRFs, Clinical Supplies and other relevant study materials
Compile and review weekly and monthly project metrics relating to study conduct e.g. Patient Screening, Recruitment & Drop-outs, Subject Logs, Safety Logs, CRF Retrieval status etc.
Manage and provide oversight to New Study Feasibilities including site feasibilities and qualification
Conduct Site Initiation Visits (SIV), conduct Protocol, ICH-GCP and SOP training at sites, demonstrate study procedures including Source Templates Filing, Annotated CRFs & CRF filling instructions (Paper/EDC), Informed Consent procedures, Patient Screening & Eligibility procedures, IP Handling procedures, Safety Reporting & Unblinding procedures etc. to investigators and CRCs, ensure timely SIV reporting & follow-up letters
Conduct routine Site Monitoring Visits (SMV) to clinical sites, do Source Doc Verification, review Site Master Files (SMFs), relevant study and patient records, resolve open site issues, ensure timely SMV reporting and follow-up letters
Verify Clinical Supplies Inventory and IP Management procedures at site and ensure complete and accurate drug accountability
Ensure Protocol Compliance in execution of trials, identify, document and resolve protocol deviations and violations, informed consent deviations and issue/action log
Ensure compliance to ICH-GCP, Indian GCP / Schedule Y and other applicable regulatory standards
Review communication of site with IRB/EC and other regulatory bodies
Act as Lead Monitor, maintain contact with site personnel and ensure timely resolution for study specific queries as well as proper escalation of site/project related issues to sponsor
Maintain audit readiness at the site level for any audits or regulatory inspections
Conduct site/study close-out activities and assure appropriate archival of controlled documents and retrieval of CRFs, Clinical Supplies and other relevant study materials
Compile and review weekly and monthly project metrics relating to study conduct e.g. Patient Screening, Recruitment & Drop-outs, Subject Logs, Safety Logs, CRF Retrieval status etc.
Manage and provide oversight to New Study Feasibilities including site feasibilities and qualification
APPLY HERE
Friday, 24 April 2015
Senior Medical Writer-Cactus Communications Pvt. Ltd. -Mumbai
- 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.
- 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
What is a typical day at work like?
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Medical Writing - Trainee ( Fresher )-Quintiles -Bengaluru/Bangalore
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
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
APPLY HERE
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.
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.
Read more
Research Coordinator-LV PRASAD EYE INSTITUTE -Hyderabad / Secunderabad
CTC: 2,50,000 - 3,75,000 P.A
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.
PG:M.Pharma - Pharmacy
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 - PharmacyPG: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
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
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
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
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
Wednesday, 22 April 2015
Submission Writer-Novartis Healthcare Pvt. Ltd. -Hyderabad / Secunderabad
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.
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.
APPLY HERE
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