Pharma, Life Science, Healthcare and Clinical Research Jobs

Friday, 31 October 2014

Career for Graduate / Post Graduate in Pharmacy as Executive/Asst. manager- Regulatory & Compliance @ GlaxoSmithKline "D8"

Career for Graduate / Post Graduate in Pharmacy as Executive/Asst. manager- Regulatory & Compliance @ GlaxoSmithKline


GlaxoSmithKline Pharmaceuticals Ltd. (GSK Rx India) is one of the oldest pharmaceuticals company and employs over 5000+ people. Globally, we are a £ 27.4 billion, leading, research-based healthcare and pharmaceutical company. In India, we are one of the market leaders. At GSK, our mission is to improve the quality of life by enabling people to do more, feel better and live longer. This mission drives us to make a real difference to the lives of millions of people with our commitment to effective healthcare solutions.

Post: Executive/Asst. manager- Regulatory & Compliance



Job Description
- To ensure compliance to regulatory and GSK Quality Management System requirements.
- Co-ordination with Tender Business Team, local FDA, Regional / Global Quality function, Manufacturing / Packing, Engineering, Warehouse and other support functions.
- Tracking of self inspection and internal audits as per the audit schedule. Review of self inspection audit reports for compliance to SOP requirements. Logging of CAPA actions of the site self inspection audits into central CAPA tracker.
- Perform allotted self inspection & internal audits as per schedule & track the CAPAs for completion.
- Perform annual review of the self inspection & internal audit systems and tracking of the actions for timely completion.
- Tracking of Quality Management System (QMS) implementation activities as per the plan. Review of gap analysis of QMS documents and tracking of actions arising out of the same.
- Ensure gap analysis of new/revised/existing QMS documents & revision of applicable SOPs in timely manner.
- Preparation and timely review of Technical Terms of Supply for export purpose. Co-ordinate with the exporting country contacts for TTS change control, registration related requirements.
- Compilation of data/details required to support the tender business.
- Preparation of Print Pack Instructions & follow up for approval of the same from other functions. Review of the Artwork prior to approval. Maintain record of the above activities.
- Timely Pharmacopoeial review to ensure product & processes are in continuous compliance with the regulatory requirements.
- Regulatory intelligence, timely review / screening of newsletters, monitoring websites, gazettes, notifications.
- Tracking and review of Key Performance Indicators (KPI). Timely support & inputs for achieving Quality KPI targets.
- Extend necessary support for new product export dossier preparation by coordinating with other support functions.
- Risks applicable in areas of responsibility are escalated in risk register in timely manner; actions are tracked for completion as per the agreed mitigation plan.
- Preparation & revision of the applicable SOPs in timely manner. Conduct SOP training to the applicable peoples.
- Preparation, storage & archival of the related documents as per GSK policy for documents maintenance.

Candidate Profile
1. Graduate / Post Graduate in Pharmacy preferably with specialization in Quality Assurance (or Post Graduate in science with relevant experience).
2. Minimum 5 to 8 years experience in handling regulatory affairs and dossier management.

Additional Information:
Experience: 5-8 years
Location: Nashik
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: DRA
End Date: 20th November, 2014
Click here to apply

Opportunity for MBBS people as Study Physician @ Intas Pharmaceuticals Ltd Freshers can apply "D7"

Opportunity for MBBS people as Study Physician @ Intas Pharmaceuticals Ltd Freshers can apply

Designation: Clinical Research Physician-CPMA
Education: MBBS
Experience: 0-4 years
Salary: 3,50,000 - 7,00,000 P.A
Company name: Intas Pharmaceuticals Ltd.
Job location: Ahmedabad
Job posted on: 29-10-14
Job duties:
>Monitor and manage adverse events
>Maintain and manage medical confidential reports
>Ensure compliance to protocol and SOPs
>Adverse tracking and follow-up of subjects
>Coordinate with screening and volunteer recruitment group on updates regarding volunteers adverse events and follow-up
>Handle safety related issues prior to and during the clinical phase of the study.
>Coordinate and conduct staff vaccination program and other related activities

Interested people send your updated CVs to rushabhshah@lambda-cro.com
Reference ID: STUDYPHYSICIAN

Opening for Associate Legal Director @ Quintiles Transnational - Bangalore, Karnataka "D6"

Opening for Associate Legal Director @ Quintiles Transnational - Bangalore, Karnataka

PURPOSE

Provide legal advice and services in one or more of the following areas: contract law, employment law, commercial law,

regulatory or compliance. May also coordinate legal matters handled by outside counsel.

RESPONSIBILITIES

The responsibilities of the role will include some or all of the following:



Review, draft and negotiate a broad range of commercial contracts. Ensure that contracts are in compliance with legal,

regulatory and organization policies. Monitor the contract process to assure compliance with the organization's

contractual guidelines, satisfaction of customers/vendors, including participation in precontract discussions, contract

negotiations and contract changes.



May provide legal advice regarding employment law. Liaise with Human Resources on all issues of the law related to the

organization's human capital. Monitor legal issues and implications regarding discrimination, sexual harassment, health

and safety, hiring and firing, as well as all other aspects of employee rights and responsibilities.



Advise and represent the organization on legal issues concerning patent, copyright, and trademark, real estate, or privacy

matters.



May examine legal data to determine advisability of defending or prosecuting a lawsuit. Study statutes, decisions and

ordinances to determine appropriate plan of action. Prepare files and take cases to trial if out-of-court settlements cannot

be reached or coordinate such legal matters handled by outside counsel. Assess impact of case outcomes and initiate

steps to implement any resultant changes.

All responsibilities are essential job functions unless noted as nonessential (N).

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES



Strong organizational, planning, project management, communication, presentation and influence skills.



Strong business acumen



Solid undertanding of the government regulations that effect the operation of the organization



Solid understanding of the pharmaceutical industry and/or drug development process



Solid understanding of drug discovery and development



Demonstrated ability to work creatively in a fast-paced environment



Demontrated sound decision-making skills



Excellent skills using MS Office Suite: MS Excel, MS Word, MS PowerPoint



Exceptional attention to detail and ability to work simultaneously on multiple priorities



Ability to work independently



Ability to establish and maintain effective working relationships with coworkers, managers and clients

MINIMUM REQUIRED EDUCATION AND EXPERIENCE



Bachelor's degree and JD with 8 years related experience, including 5 years of experience in corporate law; or equivalent

combination of education, training and experience

Qualifications

MINIMUM REQUIRED EDUCATION AND EXPERIENCE



Bachelor's degree and JD with 8 years related experience, including 5 years of experience in corporate law; or equivalent

combination of education, training and experience

-

The ideal candidate will be from a TMT (technology, media and/or telecoms) and/or pharmaceutical background and will have a mixture of private practice and in-house experience, gained working in an MNC and/or with significant experience dealing with counsel/clients and/or business partners globally.

Primary Location

:

IND-Karnataka-Bangalore

Organization

:

IND07 - India - Business Support

Regulatory Publishing - RA Associate III @ Novo Nordisk "D5"

Regulatory Publishing - RA Associate III @ Novo Nordisk
.
Education: Post graduate education within the healthcare area (e.g. Master of Pharmacy, Biotechnology, Medicinal Chemistry, Life sciences)
Experience: Atleast 2-3 years (preferred job experience in handling eCTD/NeeS/National format dossier using software).
Job location: Bangalore
Last date to apply: 30th Oct
Job duties:
>As RA Associate III your primary focus is to make sure the department can support the development, registration and maintenance of our product worldwide.
>Your task will be focused on compiling & extending support for New registration dossier in EU/US in eCTD format. Responsible of compiling registration dossier in SwissMedic, Saudi FDA, Australia in eCTD format, Dossier compilation in ASEAN CTD format for ASEAN region, Dossier compilation in National format for Brazil, Mexico, Argentina, Jordan, Russia, Turkey, etc. For other countries in NeeS format . Health Authority mandated format. We expect you to have good working experience with eCTD software or any Regulatory dossier publishing software. We also expect you to have good understanding of solving validation error & trouble shooting publishing issues.
 For further information, , please contact Surajit Roy on +91 80 39988629 or visit
Click here to apply

Openings for M.Pharmacy people @ Parexel, Freshers can apply "D4"

Openings for M.Pharmacy people @ Parexel, Freshers can apply

Education: Recognized Post graduate or PhD degree in Pharmacy/ life sciences
Experience: Preferably 1-2 years of experience with a Pharma- KPO/ Pharmaceutical company, fresher may apply
Skills Required: Good verbal and written English Communication skills
Job designation: Associate/Senior Associate
Department: PCMS
Job duties: The Associate/Senior associate role involves review of scientific literature/evidence, analysis and medical writing to support regulatory and reimbursement submissions
Company name: Parexel
Job location: Chandigarh
Job posted on: 18th Oct
Click here to apply

Jr.Trainee-Scientific Writing opening for M.Pharmacy and BDS people @ Indegene LifeSystems Pvt Ltd "D3"

Jr.Trainee-Scientific Writing opening for M.Pharmacy and BDS people @ Indegene LifeSystems Pvt Ltd

Designation: Jr.Trainee-Scientific Writing
Education: BDS or M.Pharmacy
Experience: 0-1 year
Company name: Indegene LifeSystems Pvt Ltd
Job location: Bangalore
Job posted on: 29-10-14
Required profile:
Minimum 0 to 1 years of experience in pharmaceutical companies in any of the following functions medical services/ medico-marketing/ clinical research/ regulatory affairs or in medical writing /developing/ publishing medical content.
>Strong overall understanding of science with expertise in one or more specific areas
>Strong written and verbal communication/ presentation skills; with flair for writing
>Being up-to-date with the latest technical/scientific developments in the area of health care
Job duties:
1. Responsible for referencing and uploading scientific content for medico-legal-regulatory review
2. Responsible for engaging with the creative team to develop visually engaging emodules
3. Develop scientific content for assigned tasks/assignments/modules to meet the needs of pharma clients
4. Responsible to ensure tasks are completed as per the timelines assigned
5. Responsible to follow the best practices in the department and ensure compliance with all defined processes

Interested people send your resumes to namratha.paramashiviah@indegene.com
Reference ID: HC#IND/1526/07
Contact Person name: Namratha
Phone #: 91-80-71034007

Opening for Senior Medical Writer @ PPD - Mumbai, Maharashtra "D2"

Opening for Senior Medical Writer @ PPD - Mumbai, Maharashtra

Maintain knowledge of and understand PPD SOPs, Client SOPs/directives, and current guidelines regarding clinical trials, documents and other submissions
Prepare presentation materials using the company standard graphics software
Assist with business development and pricing of projects for Medical Writing in the company
Manage Project budgeting/forecasting
Assist in identifying and recognizing out of scope activities in a contract in a timely manner
Liaise with C&PD to follow through on all aspects of contract modification
Assist business development and senior management in securing new business by making presentations to clients, developing and reviewing proposal texts and budgets, in collaboration with Proposal & Contracts Development, and conducting contract negotiations
Participate as required in project Launch Meetings, Review Meetings and Project Team meetings
Qualifications

Education and Experience:
Suitable, relevant experience working in the pharmaceutical/CRO industry is preferred

Prior experience within medical writing is required

Proven administrative and organizational skills, good computer literacy and experience

Advanced word processing, template and document management skills

Good level of experience within a broad range of Medical Writing projects, a good knowledge of global / regional Medical Writing/Regulatory Affairs for clinical trials, marketing authorization and late phase procedures

Knowledge, Skills and Abilities:
Excellent working knowledge of biomedical and statistical concepts
Excellent grammatical, editorial, and proofreading skills
Excellent problem solving capabilities and organizational skills
Ability to interpret and present extremely complex data in preparing a coherent written document
Proficient with Microsoft Word and other applicable software packages
Ability to prioritize and be adaptable to changes in work duties, responsibilities and requirements

PPD is an Equal Opportunity Employer

Job Medical Writing
Primary Location Asia Pacific-India-Maharashtra-Mumbai - Home Based

Organization Clin Dev-India (CLDIN)

Recruiter Adrian Pang
Click here to apply

Opening for Officer Quality Assurance opening for M.Pharmacy people @ Finecure Pharma "D1"

Opening for Officer Quality Assurance opening for M.Pharmacy people @ Finecure Pharma

Education: M.Pharmacy
Experience: 1-3 years
Salary: INR 1,50,000 - 3,00,000 P.A
Job location: Pantnagar, Rudrapur
Company name: Finecure Pharma
Job posted on: 22nd Oct
Skills Required: Candidate should be smart and dedicated candidate with good communication skill and individual having mindset for growth and excellence.
Job duties: Documentation, SOPs, IPQC activities-process control, coordination with other departments like production, store, QC, engineering and establishing QA systems.

Clic here to apply

Thursday, 30 October 2014

Opportunity for M.Pharm as Research Scientist (2-3 years of experience) @ Fresenius Kabi Oncology "D6"

Opportunity for M.Pharm as Research Scientist (2-3 years of experience) @ Fresenius Kabi Oncology

Fresenius Kabi Oncology Limited is a public listed company primarily operating in the field of Research & Development and manufacturing of world-class oncology drugs. The company strives to provide most advanced third generation chemotherapeutic drugs right from development to manufacturing & marketing across the globe. It is fast emerging as a leading player in oncology generics on the strength of its comprehensive product portfolio of injectables, oral cytotoxics, cytostatics, intermediates and active pharmaceutical ingredients (APIs).

Post: Research Scientist



Job 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.

Educational Qualification: M.Pharm 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

Additional Information:
Experience: 2-3 yrs
Location: Gurgaon
Qualification: M. Pharm in Pharmaceutics
Functional Area: R&D
"Industry Type: Pharma/ Biotech/Clinical Research
End Date: 30th November, 2014

Click here to apply

Opening for freshers for the post of Pharmacist @ My Health Pharmacy "D5"

Opening for the post of Pharmacist @ My Health Pharmacy


My Health Pharmacy is a first-of-its-kind pharmacy chain. Its unique value proposition is that it is not just a pharmacy store, but a health partner to its varied customers. Started in 2012, it is currently running with 14 outlets and has big plans of expansion. My Health Pharmacy assures quality health care along with having customer friendly home delivery and counseling services The employees here are the Health Partners, who are qualified and professional pharmacists.

Post: Pharmacist



No.of post: 25

Job Description
1. It’s a Role of a community pharmacist
2. Includes patient counseling
3. Customer engagement
4. Store maintenance
5. Sales



Candidate Profile
Qualification: B-Pharmacy/M-pharmacy
Experience: Only Freshers

Additional Information:
Exprience: Fresher
Qualification: B.Pharm, M.Pharm
Salary: 8-9 K per month+ incentives
Location: Hyderabad
Industry Type: Pharma
Last Date: 7th November, 2014


My Health Pharmacy is a first-of-its-kind pharmacy chain. Its unique value proposition is that it is not just a pharmacy store, but a health partner to its varied customers. Started in 2012, it is currently running with 14 outlets and has big plans of expansion. My Health Pharmacy assures quality health care along with having customer friendly home delivery and counseling services The employees here are the Health Partners, who are qualified and professional pharmacists.

Post: Pharmacist



No.of post: 25

Job Description
1. It’s a Role of a community pharmacist
2. Includes patient counseling
3. Customer engagement
4. Store maintenance
5. Sales



Candidate Profile
Qualification: B-Pharmacy/M-pharmacy
Experience: Only Freshers

Additional Information:
Exprience: Fresher
Qualification: B.Pharm, M.Pharm
Salary: 8-9 K per month+ incentives
Location: Hyderabad
Industry Type: Pharma
Last Date: 7th November, 2014

My Health Pharmacy

APPLY ONLINE
AND IF YOUR PROFILE WILL SHORT-LISTED,
YOU WILL GET CALL FROM MY HEALTH PHARMACY

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