Associate
Director - Healthcare Alliance Development
A pharmaceutical company located in Connecticut is seeking
an Associate Director, Healthcare Alliance Development
to coordinate with the Executive Director of Healthcare
Alliance Development to develop and implement strategic
plans for healthcare alliance development activities,
initiatives, and programs. This position will be responsible
for management of assigned alliance development activities
with national organizations and their identified state
chapters.
1. Strategic development and tactical implementation
of healthcare alliance development activities, initiatives
and programs.
2. Timely and effective communication with key internal
stakeholders surrounding alliance development and thought
leader activities.
3. Alliance development and relationship management
of assigned national organizations, key state organizational
stakeholders, and thought leaders.
4. Provide technical support and healthcare alliance
development information at the request of third party
organizations and internal departments to assist them
in achieving their goals.
5. Assist in the development of enduring healthcare
alliance development materials that support the company's
goals and objectives.
6. Actively participate in BBU teams and activities
as requested (i.e. the Product Informational Programs).
7. Actively lead or participate in assigned committees
as requested.
8. Manage the day to day aspects of the Healthcare Alliance
Development department including:
a. Establish and maintain database and contacts with
key thought leaders and advocates to be kept on shared
drive
b. Establish and maintain a key informational guide
and budgeting expenditures on each identified association/society
/foundation/organization to be kept on shared drive
c. Assist with development and execution of special
projects for external audiences and training for internal
audiences (e.g. Sales Training).
d. Assist in production of enduring materials for the
use of internal and external thought leaders and advocates.
This includes but is not limited to advocacy e-newsletters
and resource guides, advocacy toolkits, etc.
This position requires a well grounded understanding
of clinical, public health, and/or the pharmaceutical
industry. Excellent written and oral communication skills
(for document development & editing and interactions
with both internal & external contacts) are mandatory.
Extensive involvement and demonstrated leadership in
professional relations, association management, or consumer
advocacy is required. The incumbent may in the future
supervise and manage staff and/or consults. The position
will serve as a liaison between the company and assigned
healthcare alliance development organizations/relationships.
This position requires excellent interpersonal written
and oral communication skills. As a liaison for the
company, frequent oral & written communications
with practicing physicians, nurses, ancillary healthcare
professionals & consumers are required. In addition,
this person serves as an internal consultant on healthcare
alliance development initiatives.
A Bachelor's degree or higher in business, nursing,
pharmacy, or medicine is highly recommended. Previous
sales and marketing experience is recommended. Extensive
knowledge of consensus building, facilitating and working
with teams, engendering support, empowering others,
identifying mission match and mutually agreeable goals
is essential.
Travel is required for attending meetings, hearings,
committee meetings, scientific programs, media events,
etc. In order to comply with stated objectives it is
estimated that travel will range between 40 - 60 % of
the time. Nights or weekends will be included in activities.
Flexibility is essential for success.
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Associate
Director / Director Medical Science Liaison
An expanding pharmaceutical company centrally located
in New Jersey seeks an Associate Director/Director of
Medical Science Liaisons (MSL) to directly manage a
team of field-based MSLs and assist in setting the priorities
for proposed Investigator Initiated Clinical Research
studies and ensure that the MSL activities are entirely
consistent with current legal and regulatory guidelines.
The MSL team is responsible for providing field-based
implementation of product supportive strategies with
target customers. Emphasis is placed on professionally
and ethically developing relationships, enhancing awareness
of a disease state in which the company has interest,
and enhancing awareness of the value of products and
services marketed. Specifically, the MSL team is responsible
for the establishing, cultivating, and maintaining long-term
relationships with influential members of the medical
community within a specific geographic area. Identifying
and supporting advocates in disease states in which
the company has interest. Promoting awareness of medical/scientific
developments and issues related to disease states of
company interest and company products and facilitating
various company educational initiatives. Fostering research
collaborations (Investigator Initiated Clinical Research)
with leading academic researchers
Requirements:
An M.D., Pharm.D., or Ph.D. with 3-5 years experience
as a Medical Science Liaison. The candidate should have
exceptional communication, presentation, and leadership
skills; strong knowledge of OIG and Pharma guidelines;
effective management skills, expertise in clinical investigation
and the ability to develop productive working relationships
with external clinicians.
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Medical
Services Specialist
A pharmaceutical company located in Connecticut is seeking
a Medical Services Specialist. The Medical Services
Department is a fast-paced drug information center that
responds to medical inquiries from healthcare professionals
and patients regarding products. Qualified candidates
must have excellent communication and interpersonal
skills as well as strong organization, time management
and project management skills. Candidates should be
team-oriented, have a professional demeanor, and a proven
ability to effectively interpret, assess and communicate,
in writing and verbally, medical/scientific data.
Responsibilities include providing accurate, unbiased,
balanced, and timely responses to spontaneous medical
and pharmaceutical inquiries regarding company products
from health care professionals, patients, managed care
organizations, company sales force including field representatives,
account executives, and medical liaisons as well as
internal company customers. Additionally, the Medical
Services Specialist will be responsible for creating
written responses to inquiries, evaluating the medical
literature and compendia for assigned products and therapeutic
areas, providing product training to other departments
as needed, and function as a resource for the Marketing,
Sales Training, Regulatory, and Clinical Departments.
The Medical Services Specialist is also responsible
for verifying medical data in promotional and sales
training materials.
Experience
PharmD. Drug information experience preferred. 1-2 years
of experience in drug information role in pharma company
preferred.
Technical Skills
Ability to effectively interpret, assesses, and communicates
medical/scientific data. Proficient in Microsoft Office
Applications
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Director
Medical Information and Affairs
Location: Northern New Jersey
Reports to: Sr. Director, Medical Affairs
Well known pharmaceutical company that has experienced
rapid growth in recent years and well poised for future
growth expected has created a new position within Medical
Affairs. This is an attractive opportunity which will
enable this individual to make a major contribution
to the organization and be involved in the growth of
this relatively new department.
Position will lead Medical Affairs activities supporting
company products through developing and delivering innovative
and integrated programs and activities within the Oncology
therapy area. Provide essential support to and work
closely with the business organization (Marketing, Marketing
Research, Business Development and Licensing, sales)
as well as Regulatory Affairs and Clinical Research
groups. Develop and implement strategies and tactics
to support products throughout their life cycle partnering
with Development and commercial teams as appropriate
fostering an optimal strategic and operational synergy
between medical affairs and the commercial organization.
Ensuring that the Medical Affairs activities and programs
are conducted within an optimal regulatory compliance
framework
-Prepare comprehensive written responses for medical
information inquiries using scientific medical literature
(published and clinical study reports). Analyze and
evaluate data to compose scientific written responses.
-Serve as Medical expert for company products, providing
relevant scientific insight and support, developing
and substantiating claim support and providing oversight
and medical sign off to all related product messages
and copy.
-Coordinate with industry and professional bodies to
support commercial, Scientific and regulatory objectives
and maintaining proactive communication with colleagues
in R&D, Legal and Marketing.
-Participate in tactical and strategic project teams;
collaborating with the drug safety team to optimize
pharmacovigilance activities, including evaluation of
reports on spontaneous and clinical adverse events and
monitoring product labeling.
-Review and approve marketing and promotional materials.
- Provide support and/or presentations to Speaker Training
programs and Advisory Boards and field sales force.
-Assist in the selection of outside experts and maintaining
productive relationships with key opinion leaders in
the areas relevant to the business.
- -Seeking out opportunities to introduce and expand
position and influence in the health care environment
through appropriate targeted activities with key customers
and selective affiliations with key professional organizations.
PharmD, Ph.D or MD with 5+ years pharmaceutical industry
experience within Medical Affairs, Medical Information,
Clinical Research and or Regulatory Affairs. Minimum
of 3 years Medical Affairs experience with demonstrated
understanding of the integration of Medical information
into the commercial environment. Therapeutic area knowledge
within Cancer required with additional experience within
Anti-Infectives, AIDS, Nutrition and or Geriatric a
plus. Knowledge of Regulatory guidelines, IND/NDA requirements,
procedures and documents. Well developed research, data
analysis and summarization skills. Exceptional verbal
and written communication skills and accomplished presentation/public
speaking skills. Demonstrated project management and
coordination ability. Strategic planning, leadership
and management skills.
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Investigator-Initiated
Research/Competitor Intelligence Manager
Pharmaceutical company located in New Jersey is seeking
an Investigator-Initiated Research/ Competitor Intelligence
Manager who will have primary responsibility for management
of investigator-initiated research projects in support
of the Lipid Franchise, as per the plans and priorities
established by the Director, Clinical Applied Sciences.
In addition, this position will fulfill as a secondary
focus the responsibility for gathering, cataloging,
and disseminating scientific and competitor intelligence
relevant to the Lipid Franchise.
Position Scope: This position will directly manage Lipid
Franchise investigator-initiated research and will interact
primarily with Clinical Applied Sciences leadership.
Other key internal contacts will include leadership
of Medical Affairs, Commercial Operations-Marketing,
R&D, Legal, and Regulatory External relationships
will include outside investigators and coordinators
at centers conducting company-sponsored investigator-initiated
research.
Secondarily, this position will directly manage Lipid
Franchise scientific and competitor intelligence activities
with Clinical Applied Sciences leadership and other
Medical Affairs personnel (leadership and Medical Liaisons).
Other key internal contacts will include Commercial
Operations-Marketing, R&D, Investor Relations, and
BD&L. External relationships will include regular
contact with outside experts who possess relevant intelligence.
Responsibilities:
Maintain monthly contact with investigators/coordinators
for each trial that is active and conduct live site
visits at least once per year per study for monitoring/troubleshooting
purposes.
Serve as liaison between investigators and internal
stakeholders and resolve any issues identified by either
through making necessary connections to responsible
decision-maker(s).
Prepare and disseminate quarterly progress reports for
all trials ongoing in the program.
Coordinate internal review process for all proposed
investigator-initiated studies.
Coordinate approved new study start-up tasks and annual
study renewals with Legal, Clinical Supply, Accounting,
and other Clinical Applied Sciences.
Execute program maturation/development projects under
the direction of supervisor.
Receive, catalog, summarize, and prepare investigator-initiated
research proposals for internal review, making sure
that all required the investigator completes information
and elements.
Provide input into the development of investigator-initiated
research and scientific/competitor intelligence strategy
and budget.
Competitor Intelligence
Seek, retrieve, interpret, summarize, and catalog in
relational database from internal and external sources
all new scientific and competitor intelligence relevant
to the Lipid Franchise on a daily basis.
Prepare and disseminate quarterly summaries of key developments
on the scientific intelligence front, as well as prepare
and disseminate ad hoc briefs/communiques of time-sensitive
intelligence, to need-to-know internal stakeholders
and leadership
Attend and report on relevant medical/scientific/business
meetings of high values in terms of competitor intelligence;
coordinate with other internal personnel to gather key
information for meetings they attend
Requirements:
Minimum of BS or MS degree in a relevant health or basic/life
science; although a Pharm.D., M.D., or Ph.D. would be
preferred
Minimum basic knowledge in lipid metabolism and lipid
pharmacotherapy, and the lipid/cardiovascular disease
prevention marketplace
Experience as either an investigator or coordinator
of investigator-initiated or multicenter clinical studies
through completion; or viewed medical abstracts and
manuscripts, or significant work experience (³1-2
years) in research trial management in the pharmaceutical
industry or contract research organization
Previous relevant experience in provision of Competitor
Intelligence a plus
Demonstrable knowledge of available internet and print,
public and private domain medical information data sources,
including news, public/investor relations, clinical
trial, and medical literature retrieval services
Well-developed Internet, electronic database, and medical
literature retrieval/drug information skills
Strong written and verbal communication
Strong project management skills
Competency with Microsoft Office software (Word, Excel,
PowerPoint, Access). Competency in MS Project a plus.
Familiarity with Good Clinical Practice standards, including
Human Subjects Protection
Basic understanding of research design methodology and
proposal/grant development
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Medical
Director Clinical Research
A pharmaceutical company in Florida is seeking a Medical
Director, Clinical Research to be responsible for the
strategy and execution of global clinical development
programs for
pipeline products and clinical life cycle initiatives
Responsibilities:
- Oversight of the global clinical development program
for specific
pharmaceutical agents and formulations
- Provide clinical direction and leadership to the design
and conduct of multiple studies,
US and ex-US, leading to the registration of developmental
compounds.
- Proven capability to select and manage multinational
Scientific Advisory Boards
- Ability to lead complex global clinical programs,
with oversight of clinical trial
design, selection of appropriate clinical endpoints,
protocol design, review and
interpretation of data, and presentation of results
at scientific meetings.
- Review study timelines, resources, budgets, grants,
and grant payments with study
managers
- Ensure that clinical studies proceed on schedule,
within budget
- Work with Biometrics, Clinical Operations and Data
Management to help ensure that all data collection,
data corrections and monitoring are being performed
in accordance
with appropriate SOPs and consistent with protocol design
- Medical/clinical input into the IND/NDA process and
global regulatory interactions
- Oversight of all program ARO/CRO relationship issues
- Serve as an integral member of the global project
team, and head the clinical subteam
- Responsibilities will also include safety monitoring
and review of adverse experiences
All facets of clinical research (Phase II-IV) for pipeline
products and life cycle initiatives
Requirements:
MD, board certification in metabolism or cardiology
preferred. A minimum 3-4 years of
pharmaceutical clinical research experience strongly
preferred. Experience in diabetes
clinical research and development would be ideal. Candidate
must have a clear
understanding of the clinical and regulatory issues
regarding new product development.
Ability to manage all aspects of clinical research,
Phase II-IV inclusive. Demonstrable
leadership of multiple global clinical studies leading
to registration. Previous IND/NDA
filing experience, having played a major role in a successful
NDA application and successful management of US/EU regulatory
interactions, is a plus. Skillful management of and
interaction with scientific community, advisory boards,
and key opinion leaders
essential.
Excellent organizational skills, good verbal and written
communication skills,
professional attitude, good interpersonal skills, deadline-oriented,
delegate
efficiently, good problem-solving skills, able to work
independently, good decision-making skills, good leadership
skills.
Thorough understanding of relevant FDA regulations including
GCPs
Efficiently identify issues, secure relevant information,
and make decisions based upon logical assumptions and
factual information.
Microsoft Word, Outlook, Windows, Excel.
Ability to manage many professionals and work in a team
environment with other management personnel
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Director, Medical Affairs, Oncology
A well known branded pharmaceutical company in New
Jersey seeks a Director, Medical Affairs to be responsible
for global oversight and strategy for the medical affairs
aspects of the brand. Liaising within the company infrastructure
as well as national and international partners, to facilitate
and foster scientific exchange and development within
the international community. Strategic planning and
operational oversight of medical affairs functions.
Work in collaboration with the life cycle team leader
to develop strategic plans, in collaboration with all
international partners, and in consideration of all
ongoing and planned registration activities. Oversee
competitive intelligence efforts. Continually develop
relationships within therapeutic discipline. Team development
and ongoing training of the specialty field staff in
North America. Strategic planning and management of
mature, dynamic, and expanding Investigator Initiated
Study program. Strategic planning and operational implementation
of robust Publication Plan (30 publications, 15 abstracts,
5 oral presentations). Primary liaison to international
partners for medical affairs functions. Expert support
to specialty field staff, internal infrastructure and
associated vendors. Primary liaison to national/international
regulatory agencies for brand. Liaison to international
KOL, thought leaders, cooperative and working groups
in HSCT Clinical oversight of pharmacokinetic program
Strategic planning and operational initiation of IND
programs to explore expansion of product labeling Participate,
as needed, in review of new product acquisitions.
MD, - Oncology with 5 yrs experience in the pharmaceutical
industry. Must have 5 years experience in hematopoietic
stem cell transplantation. Knowledge of US and OUS requirements
for conduct of clinical trials and knowledge of ICH
guidelines Excellent oral, written communication and
interpersonal skills The successful candidate will also
have knowledge of effective competitive strategies as
well as an in-depth understanding of clinical product
development in the pharmaceutical industry. High analytical
skills, especially with regard to understanding and
interpreting scientific research and literature are
essential. Ability to anticipate industry trends, emerging
issues and competitive strategy is essential, as is
the appreciation of the complexities of cross-functional.
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Associate Director, Medical Development
A newly created position within an expanding pharmaceutical
company in New York State.
Primary Responsibilities:
Oversees the direction, planning, execution & interpretation
of clinical trials/research and the data collection
activities
Establishes & approves scientific methods for design
& implementation of clinical protocols, data collection
systems & final reports
May recruit clinical investigators & negotiate study
design & costs
Responsible for direction of Phase IV human clinical
trials for post-marketed products including investigator
sponsored Trials (1sts) & Registries
Uses strategic ability to take brand strategy &
translate into medical development program
Responsibilities will also include adverse event reporting
safety monitoring, and Medical, Legal & Regulatory
review of promotional & non-promotional materials
Coordinates & develops reporting information for
reports submitted for the FDA
Monitors adherence to protocols & determines study
completion
May act as a consultant/liaison with other corporations
when working on licensing agreements or intercompany
studies
Interacts with Clinical Development Team, Medical Science
Liaisons, Translational Research Investigators, and
Thought Leaders
Education/Experience Required:
Pharm D., MD, Ph.D., RN, PA degree in a scientific discipline
7+ years experience in the pharmaceutical industry
5+ years experience in oncology
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Associate Medical Director
A major branded pharmaceutical company located in New
Jersey seeks an Medical Director to oversee the medical
review of Periodic Safety Update Reports for the EU
and FDA. US IND and NDA alert reports and clinical trial
and post marketing adverse events. Adverse events and
safety reports received and prepared by DSS. Advertising
materials for marketed US product(s). Respond to queries
from internal and external Health Care Professionals.
Manage follow-up activities for post-marketing AE reported
by external Health Care Professionals, as needed. Identify,
develop and implement timely Medical Affairs strategies
with strong scientific approach and reliable clinical
judgment to create enhanced value for relevant products
Strive to gain quality data from scientific projects
for access in the worldwide markets (product profiling,
reimbursement, funding, promotional use). Work to develop
and maintain strong relationships with pharmaceutical
business partners, relevant scientific societies and
opinion leaders
Industry experience with PSUR's from the standpoint
of reviewing, interpreting and evaluating aggregate
data; Demonstrated excellence in oral and written English
communication; Ability to analyze, edit and review clinical
medical data used to prepare FDA; MedWatch & CIOMS
AE reports for medical content and International exposure.
You must be a proven leader and have supervisory experience.
Excellent communication and presentation skills.
Experience in interacting with key opinion leaders and
advisory boards. Ability to analyze complex scientific
concepts. Excellent project and time management, strategic
planning skills. Good team player interacting with different
internal departments in research and business. Problem
solver with high degree of initiative and independence.
Excellent computer skills; Ability to prioritize and
handle multiple projects simultaneously with tight deadlines
and high pressure; Ability to quickly learn products;
Ability to make decisions.
Education: Medical Doctor (M.D.) o MD from an accredited
medical school with US licensure and/or board certified
or US Educated not licensed.
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Senior Medical Information Specialist
A very progressive expanding branded pharmaceutical
company in Northern New Jersey seeks a Senior Medical
Information Specialist to deliver in an organized, timely,
responsive fashion specific answers to 'expected' requests
for information. Can recognize when the request goes
beyond this and source additional help or information
quickly and reliably including referral to medical directors.
Recognize patterns of queries that may have customer
impact and brings them to the attention of marketing
or possibly drug safety. Triage and respond to verbal
and written medical information inquiries from health
care professionals, and sales reps. Critically evaluate
and interpret data and literature to compose written
responses for dissemination to health care providers
and to provide accurate and balanced responses to inquiries.
Review promotional material to ensure that the material
is supported by scientific data, consistent with product
labeling, and is accurate; fair balanced and fulfills
regulatory requirements. Actively participate in Review
and Approval of Promotional Materials. Evaluate and
process adverse events and product complaints in compliance
with GMP and FDA regulations. Participate in other projects
including: market and competitive product research,
support of on-going clinical trials, sales training
and field liaison support as directed.
Candidate must have a PharmD or US MD with 1-5 years
experience in medical information and communication
for pharmaceutical industry and/or relevant residency
or fellowship. Candidates with a strong clinical background
and knowledge of cardiovascular medicine preferred.
Flexible, pro active, team spirited, excellent verbal
and written communication skills. Excellent verbal and
written communications skills coupled with outstanding
customer service and people skills are essential.
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Medical
Director
A pharmaceutical company located in Connecticut is seeking
a Medical director to plan, design and direct assigned
clinical research programs. Manage clinical portions
of NDA submissions. Participate in the development of
long-range plans and budgets for new products and new
indications for existing products that have been determined
to satisfy a medical need and/or offer a commercial
potential. Work within a clinical research group which
operates in compliance with Good Clinical Practices
and develop relevant formal training programs. Participate
in new product acquisitions. Candidate may function
as the clinical leader on one or more product team.
May interact with marketing to plan strategies for product
life cycle and for clinical research to support these
strategies. Promotional and other marketing materials
review.
PRINCIPAL ACTIVITIES
Plan, design and direct Phase 2 & 3 clinical development
programs and serve as Project Core Team Leader or Member.
Function as clinical leader and medical monitor on
one or more clinical study teams including managing
clinical research scientists and CRO's and other responsibilities
attended thereto.
Ensure that all studies are designed and conducted
according to GCP's and internal SOP's.
Represents company at FDA as needed and with key opinion
leaders in the field.
Evaluate and recommend clinical development plans for
new clinical candidates that come forward through internal
discovery or as in licensed opportunities.
Interact effectively with all disciplines including
regulatory affairs, bio-statistics, clinical operations,
discovery research and marketing.
REQUIRED EXPERIENCE AND EDUCATION
Requires a minimum of a medical degree and specialty
certification preferred with a minimum of 5 years experience
in the pharmaceutical industry. A strong foundation
in clinical trial design, clinical data analysis, bio-statistics
and adverse event and safety reporting is required.
Some managerial experience/training would be advantageous.
Good communication and writing skills are required.
A thorough knowledge of FDA regulations and GCP is required.
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Director, Medical Writing
Pharmaceutical company located in Florida is seeking
a Director, Medical Writing to support the writing needs
of the Research and Development division.
Position Summary:
Provide leadership and daily managerial support for
the Medical Writing department. Assign and track writing
projects. Review performance on an ongoing basis and
provide constructive feedback to staff. Assure timeliness
and accuracy of written documents. Assure compliance
with SOPs.
Responsibilities:
- Provide guidance and managerial support to Medical
Writing staff.
- Act as a liaison with Regulatory/Compliance, Clinical
Research, Clinical Pharmacology, Safety, for their medical
writing needs.
- Train all Medical and Technical Writers.
- Develop, maintain, and assure compliance with SOPs.
- Track expenditures, assist with budget preparations,
RFPs, and assure expenditures
are within budget.
- Collaborate with other members of the respective project
team(s) to gather
information, establish timeframes and priorities, and
assign and manage individual
writer roles and responsiblities in preparation of documents.
- Manage outside contracts with consultant writing groups
or other vendors
- Identify and lead writing project teams.
- Oversee the writing of Clinical Research Study Reports,
Investigator's Brochures,
Clinical Pharmacology and Clinical Research protocol
templates or full protocols upon
request as well as other projects to support various
regulatory submissions such as
portions of NDAs, NDA supplements, INDs, NDA Safety
Updates, pre-IND or pre NDA packages, as needed by Regulatory
Affairs.
- Review, edit, and assist with writing documents as
needed.
Requirements:
Post-graduate degree in a biomedical science (PharmD,
PhD, MSN, MD)
Minimum 3 years experience, as a primary author, writing
regulated scientific documents in the pharmaceutical
industry. Minimum 2 years experience managing or supervising
staff of professionals.
- AMWA certification or membership with goal of obtaining
AMWA certification.
Regulatory: Thorough understanding of relevant US FDA
and ICH guidelines for various
scientific documents; working knowledge of CTD format.
Computer: Microsoft Word, PowerPoint, Outlook, Windows,
Excel
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