Basking Ridge
NJ
Skills/Requirements
Core Competencies / Knowledge & Skill Requirements
• Experience of working with multidisciplinary groups (internal & external) and ability to work within a matrix environment.
• Manage multiple Clinical Programs
• An understanding of the drug development process and a good knowledge of the pharmaceutical industry.
• Excellent Leadership skills and capability to work within a team as leader and team player
• Excellent knowledge of regulatory requirements (ICH, GCP, Legal constraints)
• Excellent organizational and management skills.
• Excellent verbal and written communication skills.
• Strong proficiency with Microsoft software (Word, Excel, PowerPoint and Outlook).
• Excellent attention to detail, organizational and time management skills to prioritize and coordinate workload with minimal supervision.
• Strong verbal, written, and communication skills.
• Ability to work as part of a team and within a multidisciplinary environment
Education, Experience & Training Required
Experience and Education (minimums)
Substantial relevant experience of pharmaceutical drug development including project management of domestic and international clinical studies for at least 5-8 years (Pharma or CROs) for the CPM role and at least 7-10 years for the Sr. CPM role.
• Bachelors degree
• Substantial relevant experience of pharmaceutical drug development including project management of domestic and international clinical studies for at least 7-10 years (Pharma or CROs)
• Experience in team management
• Excellent knowledge of GCP/ICH regulations.
• Experience of preparing clinical study documentation.
• Experience of managing and developing relationships with CROs.
• Experience of compiling and managing clinical study budgets
Communication & Interpersonal Skills
-Written: excellent
-Verbal: excellent
-Interpersonal: excellent
Significant Contacts
-Internal – business partners across all functional areas
-External – vendors, consultants, investigators
Essential Functions – Physical Position Requirements: Machines and/or Equipment Used
-PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
-Regularly required to operate standard office equipment (personal computer, photocopy machine, fax machine, etc.)
-Ability to work on a computer up to 7 hours a day.
-Regularly required to sit for long periods of time, and occasionally stand and walk.
-Regularly required to use hands to operate computer and other office equipment.
-Close vision required for computer usage.
-Occasionally required to stoop, kneel, climb and lift up to 25 pounds.
- Up to 25% domestic travel and occasional international travel as required.
NOTE: As part of its pre-employment screening process, Ipsen Biopharmaceuticals, Inc. conducts background screening, reference checks, and drug testing. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned.
Posted On -
5/21/2013 6:46:14 AM
Basking Ridge
NJ
Skills/Requirements
Qualifications:
• Advanced and/or bachelor’s degree in a scientific discipline with a minimum of 12 years experience in the biotech/pharmaceutical industry with a minimum of 10 year in regulatory affairs.
• Proven NDA track record.
• Experience with peptides or proteins preferable.
• Experience in endocrinogy and/or oncology desired.
• Expert knowledge of regulations and drug development guidelines with some technical experience in aspects of drug development.
• Solid experience with Clinical, Non-clinical and Regulatory submissions.
• Recognized as leader, yet team player, who possesses a cross-functional collaborative skill set.
• Ability to interact effectively across all levels of the organizations; integrates functional expertise with development knowledge to solve problems, meet priorities and deadlines in alignment with corporate goals and objectives.
• Demonstrated experience leading face-to-face and other formals interactions with senior regulatory agency representatives.
• Demonstrated proficiency in organizing and planning.
• Demonstrated ability to work both independently and in a team environment.
• Excellent oral and written communication and regulatory skills with strong attention to detail and clarity.
• The ability to manage complex activities or projects.
Other:
• Some international travel required.
Posted On -
5/7/2013 6:57:55 AM
Basking Ridge
NJ
Skills/Requirements
Education and Training
• Minimum BA/BS, preferably in a scientific discipline.
• Minimum 5 years pharmaceutical/biotechnology industry experience with at least 3-5 years regulatory affairs experience.
• Experience and knowledge in the preparation of global regulatory submissions (e.g., original IND/IND amendments, CTAs, NDA/BLA/MAA).
• Knowledge and understanding of applicable global regulations, guidance documents and regulatory pathways.
• Knowledge of eCTD content/format requirements.
• Experience in Endocrinology with peptide or protein products is preferred.
• Ability to work both independently with direction and within project teams.
• Excellent verbal and written communication skills are essential.
• Strong organizational skills, including the ability to prioritize workload.
• Strong interpersonal skills and the ability to deal effectively with a variety of personnel. including medical, scientific, and manufacturing staff.
NOTE: This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned.
Posted On -
5/7/2013 6:55:07 AM
Basking Ridge
NJ
Skills/Requirements
Core Competencies / Knowledge & Skill Requirements
• Well developed scientific analytical skills so as to present complex data in an accurate and understandable manner.
• Responsible, flexible and accountable with a proactive approach and ability to work to deadlines.
Education, Experience & Training Required
Experience and Education (minimums)
• Bachelor’s degree; advanced degree preferred or equivalent in a scientific or healthcare field
• 5 - 10 years' experience in post marketing regulatory affairs including significant DDMAC compliance and interaction experience
• Experience preparing and filing Periodic Safety Update Report’s (PSUR’s) under Post Marketing Drug Risk Assessment (PMDRA).
Communication & Interpersonal Skills
-Written: excellent
-Verbal: excellent
-Interpersonal: excellent
Significant Contacts
List entities not specific names for example: vendors, FDA
-Internal –business partners
-External ––vendors, consultants
Essential Functions – Physical Position Requirements: Machines and/or Equipment Used
-PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
-Regularly required to operate standard office equipment (personal computer, photocopy machine, fax machine, etc.)
-Ability to work on a computer up to 7 hours a day.
-Regularly required to sit for long periods of time, and occasionally stand and walk.
-Regularly required to use hands to operate computer and other office equipment.
-Close vision required for computer usage.
-Occasionally required to stoop, kneel, climb and lift up to 25 pounds.
Working Conditions
Work independent
Standard office environment without unpleasant or hazardous conditions. Work entails typical physical demands involved in office work.
NOTE: As part of its pre-employment screening process, Ipsen Biopharmaceuticals, Inc. conducts background screening, reference checks, and drug testing. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned.
Posted On -
4/9/2013 8:23:38 AM
Hartford
CT
Skills/Requirements
Core Competencies / Knowledge & Skill Requirements
• Excellent sales (listening) skills
• Competitive Nature (as demonstrated in previous sales successes)
• Technical sales person, ability to analyze and discuss clinical data and articulate messages in a clear, concise fashion
• Excellent decision making skills
• Results oriented
• Business planning ability.
• Successful strategic planning and execution experience
• Ability to organize weekly/monthly sales reports
• Creative problem solver
• Takes initiative
• Excellent written and oral communication skills.
• Strong presentation skills
• Excellent leadership skills
• Proven ability to coach and mentor peers
• Strong analytical and interpretive skills
• Aptitude for learning complex scientific information
• Team player
Education, Experience & Training Required
Experience and Education (minimums)
• B.S/B.A. (advanced degree a plus) desired, equivalent experience will be considered
• 5 years Pharmaceutical/Biotech sales
• 1-2 years Endocrine Therapeutics sales experience
• Niche/orphan drug experience a plus.
• Reimbursement experience and knowledge
• Track record of sales success in the specialty Pharma/ Bio-Pharma area.
Communication & Interpersonal Skills
-Written: excellent
-Verbal: excellent
-Interpersonal: excellent
Significant Contacts
List entities not specific names for example: vendors, FDA
-Internal – business partners
-External – customers – healthcare organizations - physician
Essential Functions – Physical Position Requirements: Machines and/or Equipment Used
-PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
-Regularly required to operate standard office equipment (personal computer, photocopy machine, fax machine, etc.)
-Ability to work on a computer up to 7 hours a day.
-Ability to operate an automobile.
-Ability to travel on an airplane
-Regularly required to sit for long periods of time, and occasionally stand and walk.
-Regularly required to use hands to operate computer and other office equipment.
-Close vision required for computer usage.
-Occasionally required to stoop, kneel, climb and lift up to 25 pounds.
NOTE: As part of its pre-employment screening process, Ipsen Biopharmaceuticals, Inc. conducts background screening, reference checks, and drug testing. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned.
Posted On -
4/5/2013 8:30:08 AM
Milford
MA
Skills/Requirements
Education:
B.S. in a scientific discipline such as Biology and/or Chemistry
Required Experience and Skills:
·3-5 years of experience in the pharmaceutical industry with specific experience in a Research setting
·Informatics technical background
·Project management exposure and practical experience (PMBOK and/or SCRUM knowledge is a plus)
·Strong programming skills and web development/knowledge including HTML, JavaScript and scripting language (PHP, Perl, etc).
·Expertise with relational databases such as Oracle and PL/SQL
·Knowledge of scientific tools & standard technologies used in pharmaceutical research including expertise with Pipeline Pilot from Accelrys
·Excellent interpersonal skills, particularly the ability to communicate in an international context with multicultural/disciplinary teams and various suppliers
·Willingness and ability to travel occasionally (primarily to Ipsen’s Paris headquarters)
Preferred Qualifications:
·Demonstrated experience as a Project Manager or Leader
·Practical experience dealing with ontology, annotations notions, and knowledge network
·Knowledge of some/all of the following: Oracle Apex, Net and Java, Windows/Linux servers, Citrix, VMware
·eNotebook from CambridgeSoft (Perkin Elmer), Nautilus, Waters SMDS
·Familiarity with the French language
Physical Demands: (The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.)
·Ability to sit at a desk and use computer for extended periods of time
·Ability to speak publicly and hear in an environment with a normal level of noise
·Ability to occasionally lift items associated with an office environment, not to exceed 10 lbs.
Working Conditions: Standard office environment
Environmental, Health and Safety Requirements:
·Comply with all corporate and facility Environmental, Health and Safety policies and procedures. Attend all mandatory EHS meetings and complete all EHS training requirements.
·Intervene in potentially unsafe situations and report any incident, unsafe acts, conditions or equipment. Report any emergency situation (medical emergency/chemical spill/security concern) by following established emergency programs and procedures.
Posted On -
2/26/2013 2:19:31 PM
|