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 | Location  | City | Job Type | Job Title | Category | Status |  |
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| CT | Wallingford | Temporary | Clinical Medical Writer | Clinical | Open | | | Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together.
Come be a part of our success story!
Job Title
Position Description
- Assess scientific data contained in Clinical Study Reports, Medical Writer Experience Preferred.
Position Responsibilities
- Assess scientific data contained within the Clinical Study Reports
- Problem solve complex issues on how the data is to be displayed in the NIH system (www.ClinicalTrials.gov) by developing recommendations for the medical monitor and statistician to evaluate, enter results data into NIH database
- Meet with the clinical teams to provide guidance on reporting requirements
- Liaise w/ Statisticians & Medical Monitors
- Assist with the creation of job aides.
Position Requirements
- 5-10 years of medical writing experience
- Ability to interpret complex scientific documents
- Liaise with statisticians and medical monitors about scientific data
- Ability to be flexible, handle a high workload, work independently, be a critical thinker and problem solver, have strong communication skills and strong attention to detail and follow up skills.
Benefits
- Blue Cross/Blue Shield Medical and Vision
- Delta Dental
- 401K with Company Match
- Holiday and Vacation Pay
- Relocation Assistance
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| | | DE | Wilmington | Temporary | Clinical Medical Writer | Clinical | Open | | | The primary accountability and responsibility for this position is the development of US publication strategies and plans and the delivery of US-focussed medical, scientific and technical publications. Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together.
Come be a part of our success story!
Job Title
Position Description
- The primary accountability and responsibility for this position is the development of US publication strategies and plans and the delivery of US-focussed medical, scientific and technical publications.
- Candidates for this position must be able to lead cross functional teams to develop innovative publications strategies and plans, work with senior colleagues and external investigators and authors to deliver publications to time and quality, represent US team interests globally to ensure alignment of global and US publications strategies and plans, ensure compliance with the company Publications Policy and efficiently manage our external agencies and suppliers.
Position Responsibilities - Delivers the US-specific publication plans
- Ensures that statements and conclusions in publications are supported by appropriate data
- Provides leadership of cross-functional US Product Publications
- Delivery Team charged with delivering the US Publication strategy and plan
- Consults and liaises with external authors on matters related to publications activities
- Identifies and manages publications agencies through the effective use of project management skills to ensure the delivery of quality documents
- Edits, as appropriate, publications deliverables (eg, manuscripts, abstracts, posters)
- Participates in the negotiat ion and management of US publication budgets with US product team
- Works closely with the Global Publication Manager on all aspects of publication planning and delivery, eg, directs and manages the US review of non-US components of the global publication plan
- Contributes US perspective to the definition of the global product publication strategy and plan (in conjunction with the US and global publications teams for a product)
- Interprets and monitors current and emerging clinical communication issues and guidelines and advises the US Product Team on these issues
Position Requirements - Baccalaureate degree in biomedical discipline or equivalent
- Knowledge of the drug development process and human patho-physiology and diseases
- Excellent written and oral communication skills, manifested as the ability to express medical information accurately, clearly, and succinctly
- In depth knowledge of, and experience (5 to 7 yrs) in, the preparation of a wide range of publication types (eg, peer-reviewed journals, scientific meetings and congresses)
- Demonstrated ability to manage several projects simultaneously, including dealing with risk and issue management
- Knowledge of external publication guidelines and standards
- Ability to travel nationally and internationally
- Ability to work effectively in a cross-cultural business environment
- Influencing and negotiating skills
Preferred Background - Advanced biomedical degree
- In depth experience (7 to 10 yrs) in publication management
- Demonstrated budget and resource management skills
- Previous experience in TA areas of company product
- Awareness of pharmaceutical business practices
- Knowledge of competitors and competitor products
- Editor in Life Sciences (ELS) certification
Benefits - Blue Cross/Blue Shield Medical and Vision
- Delta Dental
- 401K with company match
- Holiday and Vacation Pay
- Relocation Assistance
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| | | IL | Deerfield | Temporary | Clinical Medical Writer | Clinical | Open | | | Sr. Level Medical writer will be working on IND submissions. Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together.
Come be a part of our success story!
Job Title
Position Description
- Sr. Level Medical writer will be working on IND submissions.
Position Responsibilities - Writing regulatory documents including, IND, NDA, IBs, Briefing Documents
Position Requirements - Bachelors Degree, preferably in the life sciences or healthcare field
- Experience writing INDs (greater than 4)
- Ability to work onsite
Benefits - Blue Cross/Blue Shield Medical and Vision
- Delta Dental
- 401K with Company Match
- Holiday and Vacation Pay
- Relocation Assistance
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| | | IL | deerfield | Permanent | Clinical Medical Writer | Clinical | Open | | | The Medical Writer III is responsible for the coordination, preparation, and completion of Periodic Adverse Drug Reports (PADERs), Periodic Safety Update reports (PSURs), and other ad hoc safety documents for submission to regulatory agencies around the world. The Medical Writer III is also a team leader providing guidance in safety writing procedures and training. Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together.
Come be a part of our success story!
Job Title
- Medical Writer III - PSUR
Position Description
- The Medical Writer III is responsible for the coordination, preparation, and completion of Periodic Adverse Drug Reports (PADERs), Periodic Safety Update reports (PSURs), and other ad hoc safety documents for submission to regulatory agencies around the world. The Medical Writer III is also a team leader providing guidance in safety writing procedures and training.
Position Responsibilities - Assist in the management of safety writing report timelines, resources, and project workload
- Assist in the training of safety writing team members, providing functional expertise and guidance
- Write and prepare standalone postmarketing aggregate safety documents for regulatory submission, such as PSURs and associated documents, and PADERs
- Ensure all safety regulatory documents are processed and submitted according to regulatory requirements
- Ensure data issues are addressed and resolved prior to document sign-off
- Facilitate document review by other contributors
- Assist with the creation and maintenance of standardized departmental procedures concerning the writing of Safety reports and processing of the reports for regulatory submission
- Participate in ongoing safety data review and analysis for products in designated therapeutic areas
- Collaborate with medical reviewers, epidemiology, and risk management concerning safety issues relative to safety writing activities
- Interface with other functional groups such as Regulatory Affairs, Quality, Information Technology, business units, as needed
- Lead or participate in project teams and committees as assigned
- Act as therapeutic area team leader
- Demonstrated leadership in a team environment
- Experience preparing postmarketing safety regulatory documents such as PSURs and associated documents, and PADERs
- Knowledge of global postmarketing safety reporting regulations and guidances
- Experience with coding dictionaries such as MedDRA
- Excellent scientific writing skills
Position Requirements - Bachelor’s degree in a medical / scientific field plus at least four (4) years pharmacovigilance experience, or a Master’s degree plus at least two (2) years pharmacovigilance experience
- Previous experience writing PADERs and/or PSURs
- Exposure to a working relationship with FDA and other regulatory authoritiesmeeting expectations of regulatory authorities for aggregate safety reports
- Experience writing in an academic research, clinical research, scientific/analytical, or medical affairs setting is a plus
- Proficiency for the following competencies are key to success in the Risk Management Group.
- Scientific and Technical Analysis - Provide Guidance to internal project teams in the area of design and analysis for more complex or high risk projects
- Submission Project Mgmt – Provide direction and guidance to more junior staff in response to complex AE reporting and content, documents, timeline
- Product/Process Quality Standards - Oversee the education of internal stakeholders on implications of regulations
Benefits - Blue Cross/Blue Shield Medical and Vision
- Delta Dental
- 401K with Company Match
- Holiday and Vacation Pay
- Relocation Assistance
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| | | NJ | Plainsboro | Temporary | Clinical Medical Writer | Clinical | Open | | | Looking for Medical Writer with experience in developing scientific publications, manuscripts, posters, abstracts and oral presentations. Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together.
Come be a part of our success story!
Job Title
Position Description
- Looking for Medical Writer with experience in developing scientific publications, manuscripts, posters, abstracts and oral presentations.
Position Responsibilities
- To work with authors to develop complex scientific manuscripts, abstracts, posters, oral presentations and other printed materials to support the clear scientific communication of products.
- Coordinate and integrate scientific and medical input from internal and external authors to meet publication deadlines with peer-reviewed journals and international congresses.
- To provide professional, expert advice to the medical and clinical teams on all matters relating to the production of publications.
- To distill, share and apply best practices so that achieves industry-leading status in speed and quality of publication production.
Position Requirements - Advanced degree: MD, PharmD, or PhD plus 2- 3 years medical writing experience
- Immunology experience preferred
- Demonstrated strong writing skills as evidenced by publications in peer-reviewed journals.
- Analyzed and interpreted complex data from a broad range of scientific disciplines
- Knowledge of statistics and their application to the interpretation and presentation of clinical data
- Demonstrated ability to manage timelines and quality of work using strong organizational, communication, facilitation and interpersonal skills in a cross-functional team
- Understanding of documentation requirements related to submission of manuscripts to scientific and medical journal
Benefits - Blue Cross/Blue Shield Medical and Vision
- Delta Dental
- 401K with Company Match
- Holiday and Vacation Pay
- Relocation Assistance
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| | | PA | Exton | Temporary | Clinical Medical Writer | Clinical | Open | | | Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together.
Come be a part of our success story!
Job Title
- Medical Director, Clinical
Position Description
- Identify, assess and appropriately manage safety signals Phase 1- Phase 4.
Position Responsibilities
- Review safety reports and safety sections for labels. Possess familiarity with biostatistics and computer data processing techniques. Must have strong interpersonal and leadership skills, self motivation, integrity, ethics and a solid commitment to drug safety.
- Review and evaluate serious event reports
- Communicate safety assessments
- Medical review for safety sections of protocols, study reports, labels and investigator brochures.
- Work with Quality Assurance, Document Management, Clinical teams, Legal,and Regulatory Affairs
Position Requirements - Associate Director- 1 to 3 years of clinical experience within a private practice or academic medical setting.
- Medical Director- 2 years of drug safety experience:
- Senior Medical Director requires 5 years.
- MD/DO board certified in internal medicine or family medicine is preferred.
- Clinical pharmacology or clinical trial experience is also preferred.
Benefits - Blue Cross/Blue Shield Medical and Vision
- Delta Dental
- 401K with Company Match
- Holiday and Vacation Pay
- Relocation Assistance
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| | | We currently do not have any other open positions that match your criteria, but new positions could become available at any time. Below is a sampling of the type of positions that we have had available in the past that match your search criteria. | | |
| | | CA | South San Francisco | Temporary | Clinical Medical Writer | Clinical | Filled | | | Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together.
Come be a part of our success story!
Job Title
- Medical Information Associate I
Position Description
- Cover our daily operational needs when the CO8 data is revealed at the beginning of May. We anticipate a doubling of calls and requests coming to our department, which will increase the regular daily work, therefore we require coverage so that our business can continue to function optimally.
Position Responsibilities - The primary focus of the Med Info Associate is to support the Medical Communications Scientists in communicating relevant and timely clinical information on our marketed products and compounds in late development.
- Independently coordinate and supervise all aspects of the fulfillment of a Medical Communications request, including the coordination of written responses, de novo literature searches, searches of the post-marketing study data base, adverse event searches and do other information searches.
Position Requirements The top three skills we require include:
- 1. Knowledge and competence with databases (if possible, specifically Reference Manager or EndNote, call center database, Livelink)
- 2. Strong verbal and written communication skills
- 3. High level proficiency with Windows 2003 - including Word, Excel, PPT.
- 4. BS degree in the life sciences or equivalent combination of education and experience. Minimum of 2 years experience.
Benefits - Blue Cross/Blue Shield Medical and Vision
- Delta Dental
- 401K with Company Match
- Holiday and Vacation Pay
- Relocation Assistance
|
| | | CT | Wallingford | Temporary | Clinical Medical Writer | Clinical | Filled | | | Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together.
Come be a part of our success story!
Job Title
· Clinical Trial Transparency Analyst - NIH liaison
Position Description
· Need individual with extensive clinical research experience to act as NIH Liaison.
Position Responsibilities
- Job requires the ability to assess scientific data, to problem solve complex issues on data presentation, and to recommendation presentation options to the medical monitor and statisticians in order to most effectively convey the results of a clinical trial.
- Entering results into NIH database
- Meeting with the clinical teams to provide guidance on NIH reporting requirements
- Liaising w/ Statisticians & Medical Monitors
- Assisting with the creation of job aides and training materials
Position Requirements · Masters Degree · More than 7 years Experience · Medial Writing/Scientific Publication Experience · Strong clinical research background, critical thinking skills, problem solving skills and excellent people skills Benefits · Blue Cross/Blue Shield Medical and Vision · Delta Dental · 401K with Company Match · Holidayand Vacation Pay · Relocation Assistance
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| | | DE | Wilmington | Temporary | Clinical Medical Writer | Clinical | Filled | | | Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together.
Come be a part of our success story!
Job Title
- Medical Communications Scientist
Position Description
- The Contract Medical Communications Scientist provides medical communication expertise in the production of regulatory documentation (including regulatory dossiers, Investigator Brochures, protocols, FDA Briefing documents) across product life cycle to ensure timely registration and to sustain competitive company products in the US.
Position Responsibilities
- Prepares regulatory documents (Investigator Brochures, clinical trial reports, NDA sections) according to agreed standards.
- Critically assesses, interprets, and accurately summarizes medical data.
- Contributes to the underlying strategy for achieving the most persuasive and effective presentation of data to the FDA to help ensure the optimal label for a product.
- Promotes and exploits global working in the preparation of clinical contributions to regulatory dossiers.
- Provides innovative advice and guidance on planning and resource forecasting for dossier and document production to enable competitive deadlines.
- Interprets and monitors current and emerging communication issues and guidelines.
- Manages contract resources through the effective use of project management skills to ensure the delivery of quality documents.
Position Requirements - Baccalaureate degree in biomedical discipline.
- Knowledge of the drug development process and human pathophysiology and diseases.
- Excellent written and oral communication skills, manifested as the ability to express medical information accurately, clearly, and succinctly.
- Demonstrated ability to manage several projects simultaneously, including dealing with risk and issue management.
- Knowledge of regulatory requirements and guidelines and standards.
- Influencing, interpersonal skills.
- Ability to travel nationally and internationally
Preferred Background: - Advanced biomedical degree.
- Budget and resource management skills.
- Previous experience in TA areas of the company product.
- Knowledge of competitors and competitor products.
- Editor in Life Sciences (ELS) certification.
Benefits - Blue Cross/Blue Shield Medical and Vision
- Delta Dental
- 401K with Company Match
- Holiday and Vacation Pay
- Relocation Assistance
|
| | | DE | Wilmington | Temporary | Clinical Medical Writer | Clinical | Filled | | | Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together. Come be a part of our success story! Job Title- Medical Communications Scientist
Position Description- The Contract Medical Communications Scientist provides medical communication expertise in the production of regulatory documentation (including regulatory dossiers, Investigator Brochures, protocols, FDA Briefing documents) across product life cycle to ensure timely registration and to sustain competitive products in the US.
Position Responsibilities- Prepares regulatory documents (Investigator Brochures, clinical trial reports, NDA sections) according to agreed standards.
- Critically assesses, interprets, and accurately summarizes medical data.
- Contributes to the underlying strategy for achieving the most persuasive and effective presentation of data to the FDA to help ensure the optimal label for a product.
Position Requirements- Baccalaureate degree in biomedical discipline.
- Knowledge of the drug development process and human pathophysiology and diseases.
- Excellent written and oral communication skills, manifested as the ability to express medical information accurately, clearly, and succinctly.
Benefits- Blue Cross/Blue Shield Medical and Vision
- Delta Dental
- 401K with Company Match
- Holiday and Vacation Pay
- Relocation Assistance
|
| | | IL | Deerfield | Permanent | Clinical Medical Writer | Clinical | Filled | | | Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together.
Come be a part of our success story!
Job Title
Position Description
- The PSUR Medical Writer is responsible for the coordination, preparation, and completion of Periodic Adverse Drug Reports (PADERs), Periodic Safety Update reports (PSURs), and other ad hoc safety documents for submission to regulatory agencies around the world.
Position Responsibilities
- Write and prepare standalone postmarketing aggregate safety documents for regulatory submission, such as PSURs and associated documents, and PADERs
- Ensure all safety regulatory documents are processed and submitted according to regulatory requirements
- Ensure data issues are addressed and resolved prior to document sign-off
- Facilitate document review by other contributors
- Assist with the creation and maintenance of standardized departmental procedures concerning the writing of safety reports and processing of the reports for regulatory submission
- Participate in ongoing safety data review and analysis for products in designated therapeutic areas
- Collaborate with medical reviewers, epidemiology, and risk management concerning safety issues relative to safety writing activities
- Interface with other functional groups such as Regulatory Affairs, Quality, Information Technology, business units, as needed
- Lead or participate in project teams and committees as assigned
- Assist in the training of new safety writing team members
Position Requirements- Experience preparing postmarketing safety regulatory documents such as PSURs and associated documents, and PADERs
- Knowledge of global postmarketing safety reporting regulations and guidances
- Experience with coding dictionaries such as MedDRA
- Excellent scientific writing skills
- Scientific / medical knowledge
- Excellent verbal and written communication skills
- Excellent analytical and problem-solving skills
- Excellent interpersonal skills
- Proficiency working in Microsoft Office applications and medical / scientific publication databases / resources
Benefits - Blue Cross/Blue Shield Medical and Vision
- Delta Dental
- 401K with Company Match
- Holiday and Vacation Pay
- Relocation Assistance
|
| | | IL | Deerfield | Permanent | Clinical Medical Writer | Clinical | Filled | | | Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together.
Come be a part of our success story!
Job Title
- Pharmacovigilance Medical Writing Manager
Position Description
The manager will supervise the Global Pharmacovigilance Medical Writing team in the coordination, preparation, and completion of Periodic Adverse Drug Reports (PADERs), Periodic Safety Update Reports (PSURs), and other ad hoc safety documents. The Manager will also write, and prepare aggregate safety documents.
Position Responsibilities- Manage, and oversee the preparation of safety documents and submissions, including complex stand alone documents as needed for submission to Regulatory Authorities for all Sponsor drug and biologic products
- Write safety documents as needed
- Owner of the report schedules
- Lead projects, establish project deadlines and monitor project progress
- Provide department metrics to senior management, including but not limited to, metrics on PADER regulatory compliance, and initiating appropriate corrective actions as necessary
- Collaborate with the other managers in safety writing to implement standardized global safety writing processes and to maximize efficiencies of the global writing team.
- Collaborate with other safety Writing managers to identify, propose, and implement improvements in safety data evaluation and report writing procedure
- Facilitate issue resolution between the safety writing team and other groups
- Partner with PVIM to facilitate data search strategies for PSURs and PADERs
- Act as the technical expert for the preparation of safety documents
- Provide guidance, coaching, and training to safety writers
- Manage, and oversee the preparation of safety documents and submissions, including complex stand alone documents as needed for submission to Regulatory Authorities for all Sponsor drug and biologic products
- Write safety documents as needed
- Owner of the report schedules
- Lead projects, establish project deadlines and monitor project progress
- Provide department metrics to senior management, including but not limited to, metrics on PADER regulatory compliance, and initiating appropriate corrective actions as necessary
- Collaborate with the other managers in safety writing to implement standardized global safety writing processes and to maximize efficiencies of the global writing team.
- Collaborate with other safety Writing managers to identify, propose, and implement improvements in safety data evaluation and report writing procedure
- Facilitate issue resolution between the safety writing team and other groups
- Partner with PVIM to facilitate data search strategies for PSURs and PADERs
- Act as the technical expert for the preparation of safety documents
- Provide guidance, coaching, and training to safety writers
Key Success Factors - Scientific and Technical Analysis –Use technical medical expertise to analyze safety data in broad terms
- Submission Project Mgmt – Oversee communication with key internal stakeholder groups and Regulators
- Product/Process Quality Standards – Influence and train others intra-departmentally on pharmacovigilance compliance
Benefits - Company Sponsored Benefits
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| | | Ma | Cambridge | Temporary | Clinical Medical Writer | Clinical | Filled | | | Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together.
Come be a part of our success story!
Job Title · Medical Writer Position Description - As a Lead Writer, will lead other writers, including developing strategies/ plans and managing projects, in order to complete multiple documents for regulatory submissions.
Position Responsibilities - Demonstrate mastery of complex writing assignments (e.g., Phase III CSRs, CSS, CSE, Background Packages, etc.) across therapeutic areas and/or multiple projects
- Participate in relevant filing subteam(s) and ensure effective planning and management of timelines for all components of assigned documents
- Lead or co-lead (with Doc Lead) teams to define content and data displays for CSR prototypes and shells
- Able to collaborate with project team to respond to health authority questions, requests
Position Requirements - PhD/MD/PharmD in a relevant scientific discipline or MS / BS with a minimum of 3 years (MS) to 5 years (BS) in pharmaceutical regulatory documentation, or equivalent, and good understanding of requirements for regulatory submission documents.
- Provide departmental management with adequate information to help assess resource needs
- Demonstrated strong writing skills as evidenced by good quality writing in pharmaceutical regulatory documentation and/or publications in peer-reviewed journals
- Good understanding of global pharmaceutical drug development and requirements for submission of regulatory dossiers to global health authorities
- Demonstrated ability to manage timelines and quality of work using strong organizational, communication, facilitation and interpersonal skills in a cross-functional team
- Working knowledge of a document management system and basic knowledge of document publishing process
- Analyzed and interpreted complex data from a broad range of scientific disciplines
- Author regulatory documents (e.g. phase I/II clinical study reports, Investigator’s Brochure) ensuring the coordination and integration of the scientific, medical and regulatory input from development team members.
Benefits · Blue Cross/Blue Shield Medical and Vision · Delta Dental · 401K with Company Match · Holidayand Vacation Pay · Relocation Assistance |
| | | NJ | Lawrenceville | Temporary | Clinical Medical Writer | Clinical | Filled | | | Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together.
Come be a part of our success story!
Job Title· Junior Publications Associate
Position Description· The position will focus on managing publication related systems and processes to ensure timely and transparent development of high quality scientific publications.Position Responsibilities · Responsible for providing project management oversight to the integration of publication management technology (PubSTRAT) to the US Medical Organization. · Assist internal and external publication team members with technical / system related questions and serve as a liaison between team members and technical support teams for relevant systems. · As publication system administrator, the selected individual will utilize systems to support internal medical communication scientists in the effective planning and management of timelines for writing deliverables; will develop, manage and track publication timelines; and will provide monthly publication performance scorecards to senior management. Position Requirements :· Minimum of 3 years project management experience in a fast paced professional environment. · Experience in biopharmaceutical industry or publication/communication agency preferred. · Demonstrated ability to navigate web-based systems and strong working knowledge of Microsoft word, PowerPoint and excel. · Possesses excellent verbal and written communication skills and ability to communicate relevant and important information across departments and outside of the company.· Demonstrates strong interpersonal skills in dealing with all levels of management. · Possesses excellent problem solving skills and demonstrates diplomacy in dealing with difficult situations; works effectively as a team member, utilizing contributions of other team members to complete projects Benefits · Blue Cross/Blue Shield Medical and Vision· Delta Dental· 401K with Company Match· Holiday and Vacation Pay· Relocation Assistance
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| | | NJ | Plainsboro | Temporary | Clinical Medical Writer | Clinical | Filled | | | Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together.
Come be a part of our success story!
Job Title
· Drug Information Manager Position Description · Provides product information support within the MedicalInformationCenter, Medical Information Department Position Responsibilities - Individual will be responsible for providing product information to both health care practitioners and patients, as well as providing medical information for the entire Pharmaceutical portfolio of products as needed.
- As part of the Medical Information team, this individual will be responsible for the oversight and assurance of credibility and balance for medical information for specific disease state and products.
- Individual will need to demonstrate superior skills in communication, collaboration and alignment when disseminating medical information.
- Has general knowledge of information technology and integrates potential applications to assess medical information delivery.
- When necessary, captures and reports adverse event and product quality complaints to Global Pharmacovigilance.
- Updates and ensures compliance to medical information standard work practices and procedures.
- In addition, the individual must have appropriate training and sensitivity to legal and regulatory issues for medical information.
Position Requirements - Thorough working knowledge of medical information development and delivery.
- Understanding of diseases and pharmacotherapy in therapeutic area.
- Knowledge of business planning and experience developing and executing strategy.
- Working knowledge of electronic communication vehicles/automated platforms.
- Must effectively manage others within the area to provide optimal service to external customers.
- Provide team support to Sales, Marketing and other areas within USP Medical Affairs. B.S. Pharmacy or Pharm.D. with a minimum of 3-5 years pharmaceutical industry experience in medical information or medically related responsibilities.
Benefits · Blue Cross/Blue Shield Medical and Vision · Delta Dental · 401K with Company Match · Holidayand Vacation Pay · Relocation Assistance |
| | | NJ | Kenilworth | Temporary | Clinical Medical Writer | Clinical | Filled | | | Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together.
Come be a part of our success story!
Job Title
Position Description
- Will be responsible for the preparation of clinical documents for worldwide submissions to regulatory authorities and for leading medical writing teams assembled to support large projects.
- Will support Managers within Medical Communications by providing technical guidance to junior members of the department.
Position Responsibilities - Independent preparation of clinical study reports, integrated clinical summaries, overviews, and other regulatory documents on investigational drugs in various stages of clinical development.
- Lead medical writing teams assembled for large projects, e.g. submissions; coordinate and direct work of internal or external medical writers assigned to the writing team.
- In conjunction with Director and MedCom Managers, will coordinate resource allocation and identify projects that exceed capacity of internal Medical Writing staff.
- Will serve as liaison between outside writing sources and will review documents prepared by those outside resources.
- Will serve as department’s representative for assigned therapy team/working groups; and will participate in determining submission-level timelines.
- Will review, update and communicate the operational and functional procedures utilized by the department with regard to document creation, review, quality control and publishing/archiving.
- Will also serve as a technical expert for the department and represent the department in cross-functional decision making teams and committees.
Position Requirements - An advanced degree in Life Sciences – PhD or PharmD preferred.
- 10 plus years in Pharmaceutical Research & Development, with at least 5 of those years in Senior-Level Medical Writing.
Benefits - Blue Cross/Blue Shield Medical and Vision
- Delta Dental
- 401K with Company Match
- Holiday and Vacation Pay
- Relocation Assistance
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| | | NJ | Plainsboro | Temporary | Clinical Medical Writer | Clinical | Filled | | | Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together. Come be a part of our success story!
Job Title- Drug Information Associate
Position Description- Represent complete and accurate Drug Information to customers
Position Responsibilities- Solid oral and written communication skills.
- Ability to Work with call center to develop relevant, unbiased, and timely responses to customer inquiries in order to meet or exceed customer satisfaction objectives.
- Ability to critically evaluate the published medical and scientific literature and write and update relevant, unbiased custom and standard response documents and product profiles to ensure information provided to customers represents the most complete and accurate information.
Position Requirements- Pharmacist
- 1-3 years of Drug Information, internships included
Benefits- Blue Cross/Blue Shield Medical and Vision
- Delta Dental
- 401K with Company Match
- Holiday and Vacation Pay
- Relocation Assistance
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| | | NJ | Lawrenceville | Temporary | Clinical Medical Writer | Clinical | Filled | | | Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together. Come be a part of our success story!
Job Title
- Medical Publications Writer
Position Description
- To develop complex scientific manuscripts, abstracts, posters, oral presentations and other printed materials to support the clear scientific communication of products.
Position Responsibilities - Coordinate and integrate scientific and medical input from internal and external authors to meet publication deadlines with peer-reviewed journalsand international congresses.
- To provide professional, expert advice to the medical and clinical teams on all matters relating to the production of publications
- To distill, share and apply best practices
Position Requirements - Advanced degree: MD, PharmD, or PhD plus medical writing experience.
- Transplant or immunology experience preferred
- Demonstrated strong writing skills as evidenced by good quality writing in publications, in peer-reviewed journals or in pharmaceutical regulatory documentation
- Analyzed and interpreted complex data from a broad range of scientific disciplines
- Knowledge of statistics and their application to the interpretation and presentation of clinical data
- Demonstrated ability to manage timelines and quality of work using strong organizational, communication, facilitation and interpersonal skills in a cross-functional team
- Understanding of documentation requirements related to submission of manuscripts to scientific and medical journals
Benefits - Blue Cross/Blue Shield Medical and Vision
- Delta Dental
- 401K with Company Match
- Holiday and Vacation Pay
- Relocation Assistance
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