Pharma, Life Science, Healthcare and Clinical Research Jobs

Tuesday, 21 October 2014

Opening for the post of Regional Sales Manager @ Naticon Research Labs "D10"

Opening  for the post of Regional Sales Manager @ Naticon Research Labs

Naticon research labs were established in 1999. It was registered as a private limited company in the year 2003. We are into manufacturing of pharmaceutical & unique herbal preparations. Business of 25 crore per year. We are the first in India to launch a prebiotic & probiotic vegetarian capsule. Recently we launched a research backed herbal preparation for pih, low foetal wt. Inadequateamneotic fluid. We will soon be launching a herbal product for regenuation of uterus after d & c. We are exporting our products to ciscontries.
1. Pharma company with special enzyme preparations of bromelain, trypsin, rutin, papain, 2. Veg capsules probiotics, veg capsules prebiotics, 3. Iron with stool softners. Herbal products for pregnancy induced hypertension, low foetal weight, low amneotic fluid.

Post: Regional Sales Manager

Job Description:
• To generate business in the entire allocated region with the help of team of ASM and Medical Representatives.
• Handling distribution channel.
• Motivating & guiding team to achieve their targets.
• Maintaining MIS of the area.
• Developing the relations with key customers / doctors of the region

Required Qualification
Education:
D Pharm. Or  Science Graduate
Experience:
Candidate should have 3 years Experience as ASM and 2 years Experience as RSM  in  Pharmaceutical industry

Salary not disclosed.

Additional Information:
Qualification: D.Pharm, B.Sc
Location: Pune
Industry Type: Pharma
Functional Area: Sales
Last Date: 15th Nov., 2014
Interested candidates mail their resumes at indiandrugs.communication@gmail.com

Opening for Associate Regulatory Affairs @ Parexel Gurgaon "D9"

Opening for Associate Regulatory Affairs @ Parexel
 
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.

Post: Associate Regulatory Affairs

Job Description
• Experienced with preparation/review of Clinical Trial Authorisation Packages for Asian countries including India.
• Awareness of regulatory requirements
• Responsible for the coordination and the preparation of /packages for MAA.
• Review and evaluate technical and scientific data and reports required for submission
• Monitor applicable regulatory requirements; assure compliance with the company’s and external standards Co-ordinate with global team for documentation
• Responding to queries raised by regulatory authorities
• Maintain regulatory files in a format consistent with requirements
• Label reviews
• Tracking submissions
• CTRI registration

Qualifications:
1-2 years experience in regulatory affairs with preparation of CTAs for Asian countries

Additional Information:
Experience: 1-2 years
Location: Gurgaon- Haryana
Functional Area: DRA
Requisition: pare-10038194
Industry Type: Pharma/ Biotech/Clinical Research
Employment Type: Full Time
Job Type: Regular
End Date: 15th November, 2014
Apply directly from here

NEWS : Government imposing ban on use of plastic containers in liquid oral preparations "D8"

Government imposing ban on use of plastic containers in liquid oral preparations

 Now in the near future, you may not see liquid orals in plastic containers because central government prohibits use of Polyethylene Terephthalate or Plastic containers for primary packaging of drug formulations in certain cases.


As per the rules published in G.S.R. 701(E) notification, 'No manufacturer shall use the Polyethylene Terephthalate or Plastic containers in liquid oral formulations for primary packaging of drug formulations for paediatric use, geriatric use and for use in case of pregnant women and women of reproductive age group.'

Central Government proposes to make, in exercise of the powers conferred by clause (i) of sub-section (2) of section 33 read with section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), on the recommendation of the Drugs Technical Advisory Board. These rules may be called as Prohibition of Use of Polyethylene Terephthalate or Plastic containers for primary packaging of drug formulations for using in certain cases Rules, 2014. 

Ministry is also highlighted that any manufacturer who contravenes the provisions shall be liable to penalty under the provisions of the Drugs and Cosmetics Act, 1940. These rules are likely to come in force after 180 days of publication of rules in Official Gazette.

Plastic containers are widely used in Indian pharmaceutical industry for liquid formulations and it will be surely affect all manufacturers. Now only future can tell on how industries react or follow the new stunning rules by government.

MANAGER, GLOBAL MEDICAL COMMUNICATION @ Abbott Laboratories - Mumbai, Maharashtra "D7"

MANAGER, GLOBAL MEDICAL COMMUNICATION @ Abbott Laboratories - Mumbai, Maharashtra

Responsible for providing global medical information and performing global medical review of

advertising and promotional materials for designated complex therapeutic areas within the

Established Pharmaceuticals Division (EPD). This includes providing expert medical responses to

unsolicited requests for medical information , and managing the development, approval, and

maintenance of medical and technical responses to inquiries on EPD products from internal

customers (such as affiliate medical staff and other global scientific colleagues) as well as from

external customers (such as health care professionals and consumers). This also includes ensuring

accurate and detailed medical review of global commercial advertising and promotional materials

against supporting documentation in compliance with global regulatory requirements. The

incumbent combines therapeutic knowledge and business acumen to develop strategies and

tactics to support the medical communication needs of EPD and affiliates.
Job Duties:

 Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

 Responsible for providing timely and accurate medical information to internal (medical

affairs, regulatory, affiliate staff) and external (consumers and healthcare professionals)

customers in response to unsolicited requests for medical information on EPD products.

 Provides timely and accurate medical review of advertising and promotional materials for

designated areas within EPD in accordance with established corporate, departmental, and

regulatory guidelines, with recognition of legal ramifications.

 Works closely with global affiliates to support medical communications strategies for their

area. Serves as contact point for key affiliates regarding medical information support needs,

and creates requested deliverables.

 Provides training to affiliates and other colleagues on medical information and medical review

skills to support their business objectives.

 Provides onboarding and training to new GMC team members on EPD products and GMC

processes.

Qualifications

Bachelor’s degree and graduation from an accredited Pharmacy, PhD in Health Sciences, or MD/DO program. Advanced degree preferred. Achieved licensure for professional practice, if appropriate for field.

Strong knowledge of industry trends and processes, clinical data, statistical concepts, and regulatory requirements regarding medical communications, advertising and promotion. Experience in both medical information and promotional review is preferred.

Minimum of 2 years work experience or 2 years postgraduate training in the pharmaceutical industry. OR Minimum of 4 years of licensed clinical practice experience.

Job Classification : Experienced
Job : CLINICAL RESEARCH
Primary Location : India-Maharashtra-Greater Mumbai

Organization : EPD-EstPharmDiv
Schedule : Full-time
Shift : Day
Travel : Yes, 15 % of the Time
Click here to apply

Govt. Job : Multiple positions opening @ Punjab pollution control board ( PPCB ) "D6"

Multiple positions open @ Punjab pollution control board ( PPCB )

Position1

Post Name : Assistant Scientific Officer
No of posts : 6
Eligiblity : Post graduate degree in first class in Basic Science or Life Science or Microbiology or
Meteorology or Environment Science or any other related Science from recognized University.
Experience :  at least five years’ experience as Junior Scientific Officer or an equivalent post in Environment related field in any Govt. organization / public sector undertaking.
Salary : Rs.10300-34800/- + 5000/- Grade Pay
Position 2

Job Title : Junior Scientific Officer
No of posts : 11
Eligiblity : Class Master’s Degree in Life Science or Basic Science or Environment Science or Biotechnology or Hydrology or Microbiology
Experience : three years’ experience in analytical work in the Govt. Department / Public Sector Undertaking Organization or a concern of repute.
Knowledge of Computer : The candidate must have  undergone a computer course of six months duration from a reputed institute.
Salary : Rs. 10300-34800/- + 4200/- Grade Pay
Position 3

Job Title : Scientific Assistant
No of posts : 13
Eligiblity : B. Sc. Degree or M.Sc. degree in Basic Science or Life Science or Environmental Science or Microbiology from a recognized university/ Institute.
Salary : Rs. 10300 -34800/- + 3200Grade Pay
How to Apply :

Eligible applicants are invited to personally submit online applications on all days during
October 8th 2014 to November 5th 2014 (up to 5.00 p.m.) in the prescribed online format
available at www.thapar.edu for the following categories of posts with payment, mode as prescribed
Click here for more details

Apply for the post of Senior Medical Writer @ Parexel "D5'

Apply for the post of Senior Medical Writer @ Parexel

Job Description :
The Senior Medical Writer researches, creates, and edits all documents associated with clinical research. Responsibilities also include: acting as primary client contact for medical writing projects, working with other PAREXEL departments and clients to set and meet internal and external deliverable timelines, leadership, training and support of junior medical writing staff.
Key Accountabilities
Write clinical documents for submission to regulatory authorities, including but not limited to: briefing documents, clinical development plans, previous human experience summaries, human pharmacology summaries, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, common technical document (CTD) clinical overviews and summaries, safety update/aggregate reports, integrated summaries of safety and efficacy.
Act in the capacity of project manager/lead for medical writing projects. This may entail serving as the primary client contact, negotiating deliverable timelines, and resolving project-related issues. Project management of contractual and financial aspects may only be performed with the guidance of medical writing management.
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.
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.
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.
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.
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.
Review statistical analysis plans and mock statistical output to assist in determining appropriateness of content/format for clinical writing.
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.
Initiate and participate in departmental or interdepartmental process improvement and training initiatives.
Initiate and manage development of formats, templates and general guidelines for clinical documentation and workflow procedures. Assist in the development of departmental SOPs.
Keep abreast of professional information and technology through workshops and conferences, and ensure the appropriate transfer of that information to the department.
Skills
Excellent interpersonal, verbal and written communication skills.
A flexible attitude with respect to work assignments and new learning.
Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.
Extensive clinical/scientific writing skills.
Advanced word processing skills, expertise in Word for Windows, ability to understand and adapt to various IT systems.
Education
Bachelor's degree in Life Sciences/Health Related Sciences or equivalent.
Language Skills
Fluent in written and spoken English.

Qualifications :
Extensive experience in clinical research/medical writing mandatory: independent writing experience with CTD documents and submissions for marketing authorisation. Phase III experience in writing multiple clinical study reports, protocols and other advanced and complex regulatory documents.

pare-10036754
Click here to apply

Medical Writing Document Manager @ Quintiles Transnational - Bangalore, Karnataka "D4"

Medical Writing Document Manager @ Quintiles Transnational - Bangalore, Karnataka

JOB DESCRIPTION 

Manage and support a team of Quality Control (QC) or Publishing staff to ensure accuracy of documents. Participate in and lead project teams and may provide service as an independent expert. Serve as QC reviewer or Document Publishing Lead for complex projects. Supports the preparation of study reports, submissions, or other documents for either internal Quintiles customers or external clients by providing quality control review, collecting appendices for documents, document preparation and publishing, and providing general assistance with document compilation. 


Opening for Associate Director Records Management @ Parexel "D3"

Associate Director Records Management @ Parexel

Job Description : 
The Associate Director is responsible for the oversight of a team of high level individual contributors or a group of Managers. This includes ensuring successful delivery of his/her organization’s project deliverables, on time with high quality. The Associate Director is an experienced leader capable of working
independently, under supervision of the Director or Sr. Director and may deputize for the Director or Sr. Director as needed.
Manage and oversee departmental activities including appropriate resourcing of staff, staff
assignments, and quality control of project deliverables and timely delivery of project
deliverables.
• Maintain an agreed level of productivity/billability and staff turnover.
• May be responsible to coordinate client or account activities for department or function.
• May serve as GMBA for a location or country.
• Participate in and contribute to project bids, including client presentations.
Ensure client and business needs are met and that all projects are optimally resourced with
suitably experienced staff.
• Ensure direct reports meet departmental and project productivity and quality metrics by
efficient execution of their project in line with project plan.
• Meet percentage of travel and billability guidelines for department, region or function, where
appropriate.
• Produce accurate resourcing plans in conjunction with appropriate Project Team Members.
• Provide expertise and consultation, facilitate metrics collection and develop action plans in
conjunction with Director/Project Leader/Lead to keep projects on time and within budget.
Drive team members to improve their efficiency and effectiveness at prioritizing work and
improving performance evidenced by the work produced, client feedback, audit results and QC
measures.
• Take appropriate action following regular feedback sessions from client’s technical groups.
• Act as executive oversight of a large project where applicable.
• Act as the client contact for local business when required.
• Implement process improvements, in conjunction with Management team and Quality
Management Group, in response to client and team feedback and quality audits.
• Follow up departmental metrics, drive team members to meet departmental goals
• Ensure management team check quality of department deliverables (e.g., site visits, Central File
documentation) and take appropriate remedial action
• Revise, implement and monitor departmental compliance with SOPs.
• Participate in committees, task force groups as needed.
• Work with senior departmental management in developing managers and ensuring a talented
pipeline of management staff within the department or function.
• Performs a leadership role in ensuring managers and staff are communicating and coordinating
efforts to provide superior line management services to staff.
• Demonstrate excellent leadership skills within department, function or location. This includes
taking an active role in departmental, functional or location activities (e.g., management
meetings), ensuring employees adhere to corporate policies and following up with management
as appropriate.
• Train and mentor new managers
• Undertake the full range of duties relevant to the leadership, management and development of
the team to ensure their performance meets and or exceeds both the business and their own
personal goals/objectives.
• Participate in PXL and department system/standards improvement activities.
• Travel as needed

Qualifications : 
Education
• Educated to a degree level (biological science, pharmacy or other health related discipline
preferred) or relevant clinical or business equivalent.
Language Skills
• Competent in written and oral English and local language
Minimum Work Experience
• Substantial monitoring/data management experience or equal experience in clinical research role.
Applicable experience in a management position.

pare-10036355

Opening for MANAGER, GLOBAL MEDICAL COMMUNICATION @ Abbott Laboratories - Mumbai, Maharashtra "D2"

Opening for MANAGER, GLOBAL MEDICAL COMMUNICATION @ Abbott Laboratories - Mumbai, Maharashtra

Responsible for providing global medical information and performing global medical review of

advertising and promotional materials for designated complex therapeutic areas within the

Established Pharmaceuticals Division (EPD). This includes providing expert medical responses to

unsolicited requests for medical information , and managing the development, approval, and

maintenance of medical and technical responses to inquiries on EPD products from internal

customers (such as affiliate medical staff and other global scientific colleagues) as well as from

external customers (such as health care professionals and consumers). This also includes ensuring

accurate and detailed medical review of global commercial advertising and promotional materials

against supporting documentation in compliance with global regulatory requirements. The

incumbent combines therapeutic knowledge and business acumen to develop strategies and

tactics to support the medical communication needs of EPD and affiliates.
Job Duties:

 Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

 Responsible for providing timely and accurate medical information to internal (medical

affairs, regulatory, affiliate staff) and external (consumers and healthcare professionals)

customers in response to unsolicited requests for medical information on EPD products.

 Provides timely and accurate medical review of advertising and promotional materials for

designated areas within EPD in accordance with established corporate, departmental, and

regulatory guidelines, with recognition of legal ramifications.

 Works closely with global affiliates to support medical communications strategies for their

area. Serves as contact point for key affiliates regarding medical information support needs,

and creates requested deliverables.

 Provides training to affiliates and other colleagues on medical information and medical review

skills to support their business objectives.

 Provides onboarding and training to new GMC team members on EPD products and GMC

processes.

Qualifications

Bachelor’s degree and graduation from an accredited Pharmacy, PhD in Health Sciences, or MD/DO program. Advanced degree preferred. Achieved licensure for professional practice, if appropriate for field.

Strong knowledge of industry trends and processes, clinical data, statistical concepts, and regulatory requirements regarding medical communications, advertising and promotion. Experience in both medical information and promotional review is preferred.

Minimum of 2 years work experience or 2 years postgraduate training in the pharmaceutical industry. OR Minimum of 4 years of licensed clinical practice experience.

Job Classification : Experienced
Job : CLINICAL RESEARCH
Primary Location : India-Maharashtra-Greater Mumbai

Organization : EPD-EstPharmDiv
Schedule : Full-time
Shift : Day
Travel : Yes, 15 % of the Time
Click here to apply

Opprtunity to work as Project Assistant @ PPD - Mumbai, Maharashtra "D1"

Opprtunity to work as Project Assistant  @ PPD - Mumbai, Maharashtra


Due to continued growth, PPD is recruiting a Project Assistant (PA) for our Brussels office. As a Project Assistant, you will be responsible for providing project administrative support to the Belgian Clinical Management teams to support global clinical research projects.

Duties include:
Maintaining of project files and documentation in an orderly manner

Coordinating travel

Assisting in the organisation of meetings

Maintain tracking databases

Other ad hoc tasks associated with clinical trials and office administration as required

Qualifications

Previous work experiences in an administrative function

Understanding of clinical Research business is desired

Ability to handle multiple tasks effectively, often within strict deadlines

Ability to work independently and prioritise your own work

Self motivated, flexible and professional attitude

In-depth knowledge of Microsoft Word, Excel and preferably PowerPoint

Fluent English

The successful candidate can look forward to job stability with a leading CRO that has experienced year-on-year growth. With future expansion plans, there is the opportunity to progress in your career with PPD. This position is full time, office based in our Mumbai location.

Job

Clinical Management

Primary Location

Asia Pacific-India-Maharashtra-Mumbai

Organization

Clin Dev-India (CLDIN)

Recruiter

Dinesh Reddy
Click here to apply

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