Sunday, 20 September 2015

Senior Medical Writer: Clinical Evaluation Report (cers) Cactus Communications

Job Description

 
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CACTUS Medical offers medical writing services to multinational biopharmaceutical and devices companies, clinicalresearch 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, experienced medical writers who have exposure to regulatory writing as well as hands-on experience of writing on medical devices or CER writing experience, and who aspire to be part of a world-class delivery team, and work in an exciting, fast-paced global environment.

As a CER writer in the CACTUS Medical team, you will:

  • Ensure timely production of high quality CERs for devices across therapeutic areas
  • Screen and summarize literature for relevant clinical data
  • Review literature to elucidate the clinical problem and current treatment techniques
  • Study and report device characteristics and instructions for use
  • Evaluate data for similar competitor devices
  • Summarize post-marketing surveillance and risk management data for the target device
  • Work with senior writers to prepare documents that meet client expectations in terms of content, format, and presentation

Location: Andheri (West)
Qualification:

  • PhD (preferably in the pharmaceutical sciences)/MBBS/MD with knowledge of clinical research, and first-author publications in international peer-reviewed journals. 
  • A Masters degree with clinical research exposure and significant publications experience can also be considered. 

Research Associate/ Scientist- Clinical Affairs F&D@ Alembic Research - 1 Opening(s) -Alembic Pharmaceuticals Limited

Job Description
 1. Responsible for clinical study monitoring, preparation of SIV, SMR for all periods, SCV for BA/BE studies.
2. Prepare, organize, conduct and follow-up site evaluation visits, site initiation visits, routine monitoring and close out visits as per relevant study plan
3. Verify quality, accuracy of data. efficient resolve data and audits queries and issues
4. Adhere to the study protocol and study procedures manual, complete all reports accurately and within the predetermined timelines
5. Review of study related documents, maintaining the project files and records for regulatory audits.
6. Responsible for maintaining study files (TMFs) at sponsor site.
7. Responsible for review of Clinical study report
8. Well versed with regulatory requirement USFDA, EMEA, ANVISA, Health Canada, DCGI, CDSCO w.r.t BA/BE and clinical studies.
9. To assist team in CRO selection as per the SOP, quality and regulatory standards.
10. To coordinate effectively with all stakeholders (PM, regulatory department, BE center, Plant QA) for smooth conduct of clinical studies.
11. Adherence to ICH-GCP and any other regulatory guidelines and requirements including adverse events and serious adverse event reporting
12. Compliance with mandatory SOPs as agreed for the study.
13. Good communication skill and Performs other duties as assigned.

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Clinical Research Coordinator TECH OBSERVER

 

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:INR 1,25,000 - 2,00,000 P.A
  

Contracts Analyst ( Clinical Research Experience )

 

 

PURPOSE
Under general supervision, develop and prepare contracts for assigned customers, to support the Global sales team.
RESPONSIBILITIES
Work closely with project teams to determine appropriate terms and conditions of contracts
Develop and prepare Contracts
Act as primary customer interface on small to mid size projects
Support senior team members on medium to larger customers / projects
Revise or develop contract and related budgets and scope of work. Ensure the scope of work is defined correctly and
budgets reflect the scope. Ensure any changes are integrated into the main study contract efficiently and accurately
Assist in the negotiation of legal contracting text using Quintiles Global Contracting Policy, templates and fallbacks
Oversee finalization and distribution of documents
Update and maintain contract databases and files
Perform all other duties as assigned
All responsibilities are essential job functions unless noted as nonessential (N).
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Knowledge of CRO Industry
Knowledge of Microsoft Excel, Word and understanding of costing models
Possess strong analytical skills and excellent verbal and written communication skills
Ability to establish and maintain effective working relationships with coworkers, managers and customers
.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Degree in Life Science, Business Management or related field and a minimum of 2-3 year's direct experience in contracts
or equivalent combination of education, training and experience
PHYSICAL REQUIREMENTS
Extensive use of telephone and face-to-face communication requiring accurate perception of speech
Extensive use of keyboard requiring repetitive motion of fingers
Regular sitting for extended periods of time
Occasional travel

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