Showing posts with label Regulatory Affairs. Show all posts
Showing posts with label Regulatory Affairs. Show all posts

Wednesday, February 8, 2012

alt-lib Suggests: Information Specialist for NDA / Regulatory Submission Job -Morristown NJ, 07960

imho, it's pretty absurd that a job with the following requirements does not require a graduate library degree. I hope an army of librarians applies to this position. It might make the recruiters think twice, the next time.
-alt-lib

- 3+ years of relevant industry or research experience, with pharmaceutical / medical experience is necessary.
- Extremely proficient on OvidSP/Medline and Embase in order to perform clinical and nonclinical literature searches.
- Experience with the most recent Medline and Embase databases.
- Keen understanding of the drug regulatory process such as NDA/IND/Periodic Safety Update annual reporting process.
- Familiar and comfortable with pharmaceutical industry and drug / chemical nomenclature
- Advanced bibliographic expertise in searching and managing information.

 Morristown Information Specialist for NDA / Regulatory Submission Job - NJ, 07960

Saturday, January 21, 2012

alt-lib Suggests: Solutions Specialist Job - Philadelphia PA, 19019 Thomson Reuters

Take a look at: Philadelphia Solutions Specialist Job - PA, 19019

EXCERPTS BELOW:

Solutions Specialist Job

Date: Jan 6, 2012
Location: Philadelphia, PA, US

Title: Solutions Specialist
ID: SAL00006861

Description

Solutions Specialist

Our life sciences knowledge and information are essential for drug companies to discover new drugs and get them to market faster, for researchers to find relevant papers and know what's newly published in their subject, and for businesses to optimize their intellectual property and find competitive intelligence.

Main Purpose for a Job:
We are looking for a Solution Specialist with a strong background in pharmaceutical regulatory procedures and requirements, who will be responsible for pre and post sales support of our IDRAC and other related products and services within the Life Sciences portfolio.

Primary job responsibilities include technical and scientific demonstrations to customers (pharmaceutical companies, biotech, academics), customer support, customer visits, training and presentations at scientific and industry meetings.

The Solution Specialist is to be motivated and articulate individual who can quickly learn and demonstrate various software tools with a high level of scientific and technical expertise. The position demands a great level of flexibility and "on-the-fly" thinking in order to relate IDRAC and Thomson Reuters Cortellis for Regulatory Intelligence tools and philosophy to professionals and academics of diverse backgrounds.

The role holder will have the ability to demonstrate fluid reasoning skills by applying the most relevant scientific and technical knowledge at any level of drug discovery, development, safety assessment, worldwide regulatory requirements and guidelines and commercialization.

....
QualificationsRole responsibilities:

Pre and Post Sales Support

- Help Sales by articulating the benefits of the Life Science products to customers with a particular focus on the IDRAC and Cortellis for Regulatory Intelligence.
- Participate in presales activities including: gathering and responding to technical questions, product presentations and sharing of best practices.
- Supporting the sales cycle for the product portfolio of Life Sciences.
- Understand how to tailor presentations to economic, technical and user buyers.
- Identify opportunities and work closely with the account teams in order to maintain and further develop client satisfaction and retention.
- Proactively initiate, design and deliver workshops and events for customers and prospects.
- Provide onsite and web-based demonstrations, training and workshops in support of sales activities to clients.
- Contribute to the development and enhancement of training and sales support materials and strategies.
- Participate in multi-client technical conferences and trade shows.
- Provide feedback to product management and sales on clients' use of products, and additional service needs.
- Deliver and organize workflow based training sessions for customers.
- Use CRM as an activity planning tool and to capture all client related activity.
- Offer strong customer service skills as demonstrated by ability to anticipate and meet customer needs and build relationships.
- Work on case studies and develop application notes

Knowledge, Skills, and Abilities Required:

- Strong background and depth of knowledge in drug regulatory procedures and processes.
- Basic knowledge and understanding of drug development lifecycle.
- Grounding in a comparable role.
- Excellent oral and written communication and presentational skills.
- General computer aptitude and quick software learning skills is an absolute must.
- Candidate should be an efficient multi-tasker, as he/she will be working in a very high-pace, dynamic environment.
- Ability to gain and retain customer confidence and respect.
- Good time management skills to plan and prioritize workload and demands.
- Ability to work with remote cross-functional and cross-cultural teams.
- Builds strong relationships internally and externally with core stakeholders.
- Customer focused and an active listener.
- Consistently delivers on commitments.

Qualifications and languages:

- Bachelor's of Science in Business, Biology, Chemistry or related fields.
- Preferably a minimum of 2 years experience in a global regulatory affairs environment.
- Experience with IDRAC and/or other similar products/competitors.
- Additional language skills is a plus.

...
Job: Sales
Primary Location: US-PA-Philadelphia
Other Locations: US-MA-Boston
Organization: Prof Science - ALL
Schedule: Full-time
Education Level: Bachelor's Degree (±16 years)
Job Type: Standard
Shift: Day Job
Travel: Yes, 50% of the time

alt-lib Suggests:Regulatory Publications Associate Job -Wilmington DE, 19801- Yoh.com (Contract)

Here's some examples of how a librarian's skills fit into this position:

Requirement: Collect necessary information and requirements from the submission team.
Skill: Reference Interview
Requrement: Compile and publish regulatory submissions in accordance with current standards and processes using agreed upon tools.
Skill: Document management.. (wide variety of skills in this one, all of which we have.)
Requirement: Ensure printing and distribution of regulatory submissions, paper and electronic, to all concerned markets, as required.
Skill: Information Management
Requirement: Perform searches on submission life-cycle information, as required.
Skill: Advanced Information Retrieval
-alt-lib

Wilmington Regulatory Publications Associate Job - DE, 19801

[EXCERPTS FOLLOW]

Regulatory Publications Associate Job

Date: Jan 10, 2012
Location: Wilmington, DE, USA
Yoh has a contract opportunity for a Regulatory Publications Associate to join our client in Wilmington, DE.

Job Responsibilities:

    - Effectively communicate submission format requirements to the submission team. - Collect necessary information and requirements from the submission team. - Compile and publish regulatory submissions in accordance with current standards and processes using agreed upon tools. - Manage assigned regulatory status information for assigned markets. - Ensure printing and distribution of regulatory submissions, paper and electronic, to all concerned markets, as required. - Analyze submissions, track and record life-cycle information in accordance with standards. - Perform searches on submission life-cycle information, as required. - Take responsibility for and ensure regulatory submissions meet all mandatory health authority validation requirements. - Participate on project teams (e.g., skill work, standards, or harmonization).

Job Qualifications:

    - University degree or relevant experience - Regulatory Publications experience is required - Strong computer skills

....
Yoh is a professional staffing provider with over 70 years of experience in the short- and long-term staffing services industry; visit our website to learn more about our company.


Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.


J2W: CLINICAL


MONJOB



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Ref: 978956