Career Biotech

Openiing for Medical Surveillance Specialist- (0.6-2 yrs exp in Clinical Research) @ Quintiles

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Openiing for Medical Surveillance Specialist- (0.6-2 yrs exp in Clinical Research) @ Quintiles<br />
<img alt="Quintiles Careers" src="http://www.naukri.com/hotjobs/images/v2/quintiles1.gif" /><br />
Dear Candidate,<br />
<br />
Looking
 for candidates with 0.6 to 2 years experience in any Clinical Research 
Domain with M.Sc/M.Pharma/BDS/BHMS/BAMS Qualification.<br />
<br />
Under
 supervision evaluating and analyzing laboratory results on a daily 
basis from sponsor designated central laboratory using 
sponsor-designated data management system.<br />
Under Supervision 
conduct the monitoring of laboratory safety parameters for each patient 
at every site throughout clinical drug trial.<br />
Under Supervision 
conducts preliminary review of laboratory results relative to 
established protocol-specific reference range guidelines.<br />
Follow 
established procedure for comparing current results with prior 
laboratory values to identify trends or potentially clinically 
significant increases/decreases.<br />
Under supervision, contact the 
investigator site for pertinent additional clinical assessment and 
consults with Sponsor/Quintiles physicians for medical evaluation of 
case, as needed.<br />
Under supervision, reviews and evaluates retest results and initiates contact with investigative site, if appropriate.<br />
Composes
 telephone reports documenting site contact to include all clinically 
relevant information. Distributes according to scheme designated at 
project inception.<br />
Assists Medical Surveillance Specialist with project set-up activities.<br />
Attends investigator/study start-up meetings as requested by Sponsor and/or Quintiles physicians.<br />
Maintains
 up-to-date laboratory knowledge via continuing education activities( 
like completion of continuing education class, applicable QU courses 
review of journal articles) or attendance at medical seminars.<br />
Attends project team meetings, as needed.<br />
Performs other related duties as assigned.<br />
<br />
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES<br />
Basic Knowledge of Medical /Scientific Terminology <br />
Basic
 knowledge of applicable research and regulatory requirements; i.e., ICH
 GCP and relevant local laws, regulations and guidelines <br />
Excellent organizational, communication and computer skills required.<br />
Ability to exercise excellent attention to detail.<br />
Ability to act independently and with initiative required to resolving problems.<br />
Strong analytical skills<br />
Strong Excel Skills<br />
Ability to establish and maintain effective working relationships with coworkers, managers and clients<br />
<br />
Regards,<br />
<br />
Ashwini<br />
Salary: Not Disclosed by Recruiter<br />
Industry:Pharma / Biotech / Clinical Research<br />
Functional Area: Other<br />
Role Category:Other<br />
Role:Other<br />
<br />
<span style="font-size: large;"><b><a href="http://jobsearch.naukri.com/job-listings-Medical-Surveillance-Specialist-0-6-2-yrs-exp-in-Clinical-Research--Quintiles-Bengaluru-Bangalore-1-to-2-years-010715001966?xp=1&qp=pharmacovigilance&srcPage=s" target="_blank">Click here to apply</a></b></span></div>

Openiing for Medical Surveillance Specialist- (0.6-2 yrs exp in Clinical Research) @ Quintiles

Openiing for Medical Surveillance Specialist- (0.6-2 yrs exp in Clinical Research) @ Quintiles Dear Candidate, Looking for candidates ...

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Inspirational Short Story on Relationships!!! Building Bridges "H5"

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<span style="background-attachment: initial; background-clip: initial; background-color: transparent; background-image: initial; background-origin: initial; background-position: initial; background-repeat: initial; background-size: initial; border-image-outset: initial; border-image-repeat: initial; border-image-slice: initial; border-image-source: initial; border-image-width: initial; border: 0px; margin: 0px; padding: 0px; vertical-align: baseline;"><i style="background-attachment: initial; background-clip: initial; background-color: transparent; background-image: initial; background-origin: initial; background-position: initial; background-repeat: initial; background-size: initial; border-image-outset: initial; border-image-repeat: initial; border-image-slice: initial; border-image-source: initial; border-image-width: initial; border: 0px; margin: 0px; padding: 0px; vertical-align: baseline;"><b><span style="color: red;"><u>Inspirational Story on Relationships!!! Building Bridges</u></span></b></i></span></div>
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<img alt="inspirational short story on relationships, family , motivational stories 2015" height="390" src="http://rishikajain.com/wp-content/uploads/2015/02/we-build-too-many-walls-and-not-enough-bridges-quote-1.jpg" width="640" /></div>
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Once upon a time two brothers who lived on adjoining farms fell into conflict. It was the first serious rift in 40 years of farming side by side, sharing machinery, and trading labor and goods as needed without a hitch.</div>
<div style="background: rgb(255, 255, 255); border: 0px; color: #333333; font-family: Georgia, 'Bitstream Charter', serif; font-size: 16px; line-height: 18px; margin-bottom: 24px; padding: 0px; vertical-align: baseline;">
<span style="background: transparent; border: 0px; color: #6600ff; margin: 0px; padding: 0px; vertical-align: baseline;">Then the long collaboration fell apart. It began with a small misunderstanding and it grew into a major difference, and finally it exploded into an exchange of bitter words followed by weeks of silence.</span></div>
<div style="background: rgb(255, 255, 255); border: 0px; color: #333333; font-family: Georgia, 'Bitstream Charter', serif; font-size: 16px; line-height: 18px; margin-bottom: 24px; padding: 0px; vertical-align: baseline;">
<span style="background: transparent; border: 0px; color: #6600ff; margin: 0px; padding: 0px; vertical-align: baseline;">One morning there was a knock on John’s door. He opened it to find a man with a carpenter’s toolbox. “I’m looking for a few days work,” he said.</span></div>
<div style="background: rgb(255, 255, 255); border: 0px; color: #333333; font-family: Georgia, 'Bitstream Charter', serif; font-size: 16px; line-height: 18px; margin-bottom: 24px; padding: 0px; vertical-align: baseline;">
<span style="background: transparent; border: 0px; color: #6600ff; margin: 0px; padding: 0px; vertical-align: baseline;">“Perhaps you would have a few small jobs here and there. Could I help you?”</span></div>
<div style="background: rgb(255, 255, 255); border: 0px; color: #333333; font-family: Georgia, 'Bitstream Charter', serif; font-size: 16px; line-height: 18px; margin-bottom: 24px; padding: 0px; vertical-align: baseline;">
<span style="background: transparent; border: 0px; color: #6600ff; margin: 0px; padding: 0px; vertical-align: baseline;">“Yes,” said the older brother. “I do have a job for you. Look across the creek at that farm. That’s my neighbor, in fact, it’s my younger brother. Last week there was a meadow between us and he took his bulldozer to the river levee and now there is a creek between us. Well, he may have done this to spite me, but I’ll go him one better. See that pile of lumber curing by the barn? I want you to build me a fence – an 8-foot fence – so I won’t need to see his place anymore. Cool him down, anyhow.”<span id="more-20586" style="background: transparent; border: 0px; margin: 0px; padding: 0px; vertical-align: baseline;"></span></span></div>
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<span style="background: transparent; border: 0px; color: #6600ff; margin: 0px; padding: 0px; vertical-align: baseline;">The carpenter said, “I think I understand the situation. Show me the nails and the post-hole digger and I’ll be able to do a job that pleases you.”</span></div>
<div style="background: rgb(255, 255, 255); border: 0px; color: #333333; font-family: Georgia, 'Bitstream Charter', serif; font-size: 16px; line-height: 18px; margin-bottom: 24px; padding: 0px; vertical-align: baseline;">
<span style="background: transparent; border: 0px; color: #6600ff; margin: 0px; padding: 0px; vertical-align: baseline;">The older brother had to go to town for supplies, so he helped the carpenter get the materials ready and then he was off for the day.</span></div>
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<span style="background: transparent; border: 0px; color: #6600ff; margin: 0px; padding: 0px; vertical-align: baseline;">The carpenter worked hard all that day measuring, sawing, nailing.</span></div>
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<span style="background: transparent; border: 0px; color: #6600ff; margin: 0px; padding: 0px; vertical-align: baseline;">About sunset when the farmer returned, the carpenter had just finished his job. The farmer’s eyes opened wide, his jaw dropped.</span></div>
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<span style="background: transparent; border: 0px; color: #6600ff; margin: 0px; padding: 0px; vertical-align: baseline;">There was no fence there at all. It was a bridge… a bridge stretching from one side of the creek to the other! A fine piece of work handrails and all – and the neighbor, his younger brother, was coming across, his <a href="http://www.amazon.com/dp/B001F9APK0" rel="nofollow" style="background: transparent; border: 0px; color: #743399; margin: 0px; padding: 0px; vertical-align: baseline;" target="_blank" title="Link added by VigLink">hand outstretched</a>.</span></div>
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<span style="background: transparent; border: 0px; color: #6600ff; margin: 0px; padding: 0px; vertical-align: baseline;">“You are quite a fellow to build this bridge after all I’ve said and done.”</span></div>
<div style="background: rgb(255, 255, 255); border: 0px; color: #333333; font-family: Georgia, 'Bitstream Charter', serif; font-size: 16px; line-height: 18px; margin-bottom: 24px; padding: 0px; vertical-align: baseline;">
<span style="background: transparent; border: 0px; color: #6600ff; margin: 0px; padding: 0px; vertical-align: baseline;">The two brothers stood at each end of the bridge, and then they met in the middle, taking each other’s hand. They turned to see the carpenter hoist his toolbox on his shoulder. “No, wait! Stay a few days. I’ve a lot of other projects for you,” said the older brother.</span></div>
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“I’d love to stay on,” the carpenter said, “but, I have many more bridges to build.</div>
</div>

Inspirational Short Story on Relationships!!! Building Bridges "H5"

Inspirational Story on Relationships!!! Building Bridges Once upon a time two brothers who lived on adjoining farms fell into conf...

Work as Clinical Data Manager in inVentiv Health Clinical "H4"

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<span style="font-family: verdana, geneva, sans-serif; margin: 0px; padding: 0px;">inVentiv Health Clinical, a leader in drug development services, has a global infrastructure, therapeutic expertise, and commitment to quality that is unmatched in the industry. For pharmaceutical, biotechnology, generic drug, and medical device companies of all sizes around the world, inVentiv Health Clinical can help you transform promising ideas into commercial reality.</span></div>
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<span style="font-family: verdana, geneva, sans-serif; margin: 0px; padding: 0px;"><span style="color: black; margin: 0px; padding: 0px;"><span style="color: indigo; margin: 0px; padding: 0px;"><strong style="margin: 0px; padding: 0px;">Post: </strong></span></span>Clinical Data Manager</span></div>
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<span style="font-family: verdana, geneva, sans-serif; margin: 0px; padding: 0px;"><span style="color: indigo; margin: 0px; padding: 0px;"><strong style="margin: 0px; padding: 0px;">Job Description</strong></span><br style="margin: 0px; padding: 0px;" />•Perform data review and query generation</span></div>
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<span style="font-family: verdana, geneva, sans-serif; margin: 0px; padding: 0px;">•Assist in defining edit checks to be programmed for the study /project</span></div>
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<span style="font-family: verdana, geneva, sans-serif; margin: 0px; padding: 0px;">•Review programmed edit checks</span></div>
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<span style="font-family: verdana, geneva, sans-serif; margin: 0px; padding: 0px;">•Track study progress and issue periodic status report</span></div>
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<span style="font-family: verdana, geneva, sans-serif; margin: 0px; padding: 0px;">•Update the data base to correct errors</span></div>
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<span style="font-family: verdana, geneva, sans-serif; margin: 0px; padding: 0px;">•Code Case Report Form(CRF) verbatim terms using Pharmanet/i3 or sponsor supplied dictionaries</span></div>
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<span style="font-family: verdana, geneva, sans-serif; margin: 0px; padding: 0px;">•Process electronic data received from outside vendors</span></div>
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<span style="font-family: verdana, geneva, sans-serif; margin: 0px; padding: 0px;">•Participate</span><span style="font-family: verdana, geneva, sans-serif; margin: 0px; padding: 0px;"> in the completion of all quality control measures necessary for the finalization and transfer of the database and related materials to the sponsor</span></div>
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<span style="font-family: verdana, geneva, sans-serif; margin: 0px; padding: 0px;">•Identify the achievement of milestones to the Lead Data Analyst, e.g., database status as "draft" or "final"</span></div>
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<span style="font-family: verdana, geneva, sans-serif; margin: 0px; padding: 0px;">•May act as Lead Clinical Data Manager for assigned studies or projects</span></div>
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<span style="font-family: verdana, geneva, sans-serif; margin: 0px; padding: 0px;">•May coordinate the work of Associate Clinical Data Managers assigned to the project</span></div>
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<span style="font-family: verdana, geneva, sans-serif; margin: 0px; padding: 0px;">•May provide training on data management procedures and system</span></div>
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<span style="font-family: verdana, geneva, sans-serif; margin: 0px; padding: 0px;">•May create data management plan for the study /project</span></div>
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<span style="font-family: verdana, geneva, sans-serif; margin: 0px; padding: 0px;">•May assist in the review of database design</span></div>
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<span style="font-family: verdana, geneva, sans-serif; margin: 0px; padding: 0px;">•May develop and design CRF's,or participate in the review of sponsor-generated CRF</span></div>
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<span style="font-family: verdana, geneva, sans-serif; margin: 0px; padding: 0px;"><span style="color: indigo; margin: 0px; padding: 0px;"><strong style="margin: 0px; padding: 0px;">Candidate Profile</strong></span><br style="margin: 0px; padding: 0px;" />- Bachelor's Degree or RN; in lieu of Bachelor's Degree or RN, four years experience in clinical research, drug development, or other healthcare environment, including eighteen months experience in data management<br style="margin: 0px; padding: 0px;" />- 4 to 5 year sof relevant clinical or data management experience<br style="margin: 0px; padding: 0px;" />- Hands on experience in Rave EDC<br style="margin: 0px; padding: 0px;" />- Proven data management skills<br style="margin: 0px; padding: 0px;" />- Effective communication skills</span></div>
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<span style="font-family: verdana, geneva, sans-serif; margin: 0px; padding: 0px;"><span style="color: indigo; margin: 0px; padding: 0px;"><strong style="margin: 0px; padding: 0px;">Additional Information:</strong></span><br style="margin: 0px; padding: 0px;" /><strong style="margin: 0px; padding: 0px;">Qualification:</strong> <span style="margin: 0px; padding: 0px;">Bachelor's Degree</span><br style="margin: 0px; padding: 0px;" /><strong style="margin: 0px; padding: 0px;">Job ID:</strong> 10333<strong style="margin: 0px; padding: 0px;"><br style="margin: 0px; padding: 0px;" />Location: </strong>Pune</span><span style="font-family: verdana, geneva, sans-serif; margin: 0px; padding: 0px;">/ Hyderabad<br style="margin: 0px; padding: 0px;" /><strong style="margin: 0px; padding: 0px;">Industry Type:</strong> Clinical Research<br style="margin: 0px; padding: 0px;" /><strong style="margin: 0px; padding: 0px;">Functional Area:</strong> Medical Writing<br style="margin: 0px; padding: 0px;" /><strong style="margin: 0px; padding: 0px;">Last Date:</strong> 25<sup style="margin: 0px; padding: 0px;">th</sup> July, 2015</span></div>
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Work as Clinical Data Manager in inVentiv Health Clinical "H4"

inVentiv Health Clinical, a leader in drug development services, has a global infrastructure, therapeutic expertise, and commitment to qua...

Career opportunity as Medical Writer II in Parexel "H3"

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<span style="font-family: verdana, geneva, sans-serif; margin: 0px; padding: 0px;">PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, they supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries. They have helped over 800 clients to develop and launch some of the most important drugs and devices of our time-helping people live better and healthier lives everywhere in the world. Headquartered near Boston, Massachusetts, PAREXEL operates in more than 50 countries around the world.</span></div>
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<span style="font-family: verdana, geneva, sans-serif; margin: 0px; padding: 0px;"><span style="color: black; margin: 0px; padding: 0px;"><span style="color: indigo; margin: 0px; padding: 0px;"><b style="margin: 0px; padding: 0px;">Post: </b></span></span>Medical Writer II</span></div>
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<span style="font-family: verdana, geneva, sans-serif; margin: 0px; padding: 0px;"><span style="color: indigo; margin: 0px; padding: 0px;"><b style="margin: 0px; padding: 0px;">Job Description:</b></span><br style="margin: 0px; padding: 0px;" />Under departmental supervision, the Medical Writer II will research, create, edit, and coordinate the production of clinical documents associated with submissions to regulatory authorities including but not limited to: study protocols, model informed consents, interim and final clinical study reports and safety updates. The Medical Writer II will also be responsible for the production of clinical study documentation associated with clinical trials that may not be included in a regulatory submission. The Medical Writer II may serve as primary technical contact with client under appropriate departmental supervision.</span></div>
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<span style="font-family: verdana, geneva, sans-serif; margin: 0px; padding: 0px;"><b style="margin: 0px; padding: 0px;">Relationships</b><br style="margin: 0px; padding: 0px;" />Reports To Departmental Line Management, Medical Writing Services<br style="margin: 0px; padding: 0px;" />Directly Supervises None<br style="margin: 0px; padding: 0px;" />Provides Work Direction to Medical Writer I, Associate Medical Writer, Medical Writing Assistant<br style="margin: 0px; padding: 0px;" />Works Closely with Project Managers/Leaders Physicians, Biostatisticians, Data Managers, Regulatory Associates, Medical Writing staff<br style="margin: 0px; padding: 0px;" />External Relationships Client technical representatives</span></div>
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<span style="font-family: verdana, geneva, sans-serif; margin: 0px; padding: 0px;"><b style="margin: 0px; padding: 0px;">Key Accountabilities:</b><br style="margin: 0px; padding: 0px;" />- Write clinical documents associated with submissions to regulatory authorities including but not limited to: study protocols, model informed consents, interim and final clinical study reports and safety updates.<br style="margin: 0px; padding: 0px;" />- Serve as the primary client contact, negotiating deliverable timelines, and resolving project related issues, under departmental supervision. Project management of contractual and financial aspects may only be performed with the guidance of medical writing management.<br style="margin: 0px; padding: 0px;" />- Serve as the Medical Writing representative on assigned project teams, providing proactive support to Project Leadership for planning efficient work plans and timelines for medical writing deliverables, and medical writing input into other departmental deliverables. Identify any potential project challenges to departmental line management and project leader including changes in project plan, timeline or out of scope requests, and suggest possible resolution options.<br style="margin: 0px; padding: 0px;" />- Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copyediting and content review.<br style="margin: 0px; padding: 0px;" />- Ensure document content and style adheres to FDA/EMA or other appropriate regulatory guidelines, and complies with departmental and corporate or client SOPs and style guidelines.<br style="margin: 0px; padding: 0px;" />- Coordinate and conduct interdepartmental team review and sign-off of document deliverables according to PAREXEL guidelines/SOPs including: distribute drafts, chair review meeting, incorporate revisions, document key project events, and complete sign-off procedures.<br style="margin: 0px; padding: 0px;" />- Coordinate production and distribution of draft and final documents to project team and client. Ensure that all work is complete and of high quality prior to team distribution or shipment to client.<br style="margin: 0px; padding: 0px;" />- Perform literature searches/reviews as necessary to obtain background information and training for development of documents.<br style="margin: 0px; padding: 0px;" />- Review statistical analysis plans and mock statistical output to determine the appropriateness of content/format for clinical writing.<br style="margin: 0px; padding: 0px;" />- Attend internal technical team and client team meetings as required.<br style="margin: 0px; padding: 0px;" />- May provide guidance to less experienced departmental members.<br style="margin: 0px; padding: 0px;" />- Supervise collection of materials by the Medical Writing Assistant or Associate Medical Writer for assembly of client deliverables and for filing appropriately in project files.<br style="margin: 0px; padding: 0px;" />- May participate in departmental or interdepartmental process improvement and training initiatives.<br style="margin: 0px; padding: 0px;" />- May participate in development of formats, templates and general guidelines for clinical documentation and workflow procedures. Assist in the development of departmental SOPs.<br style="margin: 0px; padding: 0px;" />- Keep abreast of professional information and technology through workshops and conferences, and ensure the appropriate transfer of that information to the department.</span></div>
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<span style="font-family: verdana, geneva, sans-serif; margin: 0px; padding: 0px;"><span style="color: indigo; margin: 0px; padding: 0px;"><b style="margin: 0px; padding: 0px;">Skills</b></span><br style="margin: 0px; padding: 0px;" />• Excellent interpersonal, verbal and written communication skills.<br style="margin: 0px; padding: 0px;" />• Client focused approach to work.<br style="margin: 0px; padding: 0px;" />• A flexible attitude with respect to work assignments and new learning.<br style="margin: 0px; padding: 0px;" />• Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.<br style="margin: 0px; padding: 0px;" />• Willingness to work in a matrix environment and to value the importance of teamwork.<br style="margin: 0px; padding: 0px;" />• Demonstrated understanding of the drug development process.<br style="margin: 0px; padding: 0px;" />• Extensive clinical/scientific writing skills.<br style="margin: 0px; padding: 0px;" />• Advanced word processing skills/familiarity with Word for Windows.</span></div>
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<span style="font-family: verdana, geneva, sans-serif; margin: 0px; padding: 0px;"><b style="margin: 0px; padding: 0px;">Education</b><br style="margin: 0px; padding: 0px;" />• Bachelor's degree in Life Sciences/Health Related Sciences or equivalent.</span></div>
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<span style="font-family: verdana, geneva, sans-serif; margin: 0px; padding: 0px;"><b style="margin: 0px; padding: 0px;">Language Skills</b><br style="margin: 0px; padding: 0px;" />• Fluent in written and spoken English.</span></div>
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<span style="font-family: verdana, geneva, sans-serif; margin: 0px; padding: 0px;"><b style="margin: 0px; padding: 0px;">Minimum Work Experience</b><br style="margin: 0px; padding: 0px;" />• Medical writing experience: experience in writing multiple clinical study reports.</span></div>
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<span style="font-family: verdana, geneva, sans-serif; margin: 0px; padding: 0px;"><span style="color: indigo; margin: 0px; padding: 0px;"><b style="margin: 0px; padding: 0px;">Additional Information:</b></span><b style="margin: 0px; padding: 0px;"><br style="margin: 0px; padding: 0px;" /></b><b style="margin: 0px; padding: 0px;">Qualification:</b> <span style="margin: 0px; padding: 0px;">Bachelor's degree in Life Sciences</span><b style="margin: 0px; padding: 0px;"><br style="margin: 0px; padding: 0px;" />Location: </b>Karnataka - Bangalore<br style="margin: 0px; padding: 0px;" /><b style="margin: 0px; padding: 0px;">Industry Type: </b>Pharma/ Biotech/Clinical Research<br style="margin: 0px; padding: 0px;" /><b style="margin: 0px; padding: 0px;">Functional Area:</b> Medical Writing<br style="margin: 0px; padding: 0px;" /><span style="margin: 0px; padding: 0px;"><b style="margin: 0px; padding: 0px;">Requisition #:</b> pare-10043635</span><br style="margin: 0px; padding: 0px;" /><b style="margin: 0px; padding: 0px;">End Date:</b> 30<sup style="margin: 0px; padding: 0px;">th</sup> July, 2015</span></div>
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Career opportunity as Medical Writer II in Parexel "H3"

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