- Pharmacovigilance Medical Writer II -- Baxter International Inc., Deerfield, IL
- Senior Medical Writer -- Real Pharma, Switzerland
Now, a colleague sent me a link to a chart illustrating the risks of the HPV vaccine. Very telling. See it here.
Saturday, October 24, 2009
Jobs and Cool Risk Communication Graphic
Saturday, October 17, 2009
Did you miss the CME Webinar?
We had a great response from attendants to the Free Webinar "CME Opportunities for Medical Writers." But many said they couldn't attend because of schedule conflicts. That's why we are offering the seminar again on Sunday, October 25th at 11:00 AM EST.
Don't miss this opportunity to learn how to expand your medical writing business. Register for the FREE Webinar at the link below:
https://www1.gotomeeting.com/register/127287417
Don't miss this opportunity to learn how to expand your medical writing business. Register for the FREE Webinar at the link below:
https://www1.gotomeeting.com/register/127287417
Medical Writing Position in NJ
Sr. Manager, Medical Writing Job Description:
"Growing Pharmaceutical Company located in Princeton, NJ is seeking for a Sr. Manager, Medical Writing to join their organization"Duties and Responsibilities:
-Serve as the medical writing (MW) representative on Project Teams.
-Provide input to the development of strategy for multinational clinical activities associated with registration and market support of a product.
-Review medical documents generated outside of MW (e.g. Study Protocols, Statistical Analysis Plans, Tables and Listings).
-Prepare/coordinate clinical documents as required (e.g. Clinical Trial Reports (Phase I – IV) and associated appendices, Investigator’s Brochures, Periodic Safety Update Reports, Annual Safety Reports, Ad Hoc Safety Reports, clinical sections of IND/IMPD/NDA/MAA/CTD). Resolve conflicting comments among reviewers and collate comments for submission to consultants/CRO as necessary.
-Prepare/coordinate clinical sections of submission (IND/IMPD/NDA/MAA//CTD) and responses to regulatory authorities, and implement medical writing activities. Interact with multi-disciplinary team members (regulatory, physicians, statisticians, clinicians, data managers and drug safety group) as applicable. Discuss the objectives, timelines, and documents to be generated; coordinate contributions from other groups and pull together the documents in a efficient, non-disruptive manner for submissions to regulatory authorities.
-Manage the activities of internal/external resources and medical writing vendors (i.e. individual consultant medical writers and contract research organization (CRO) medical writers).
-Prepare/review SOP’s and document templates.
-Manage projects within pre-defined budget, pre-defined internal resources and time constraints
-Providing status reports for ongoing projects
Core Competencies:
-Demonstrated medical writing skills and high level interpersonal skills to interact effectively within team and matrix work settings. Sensitivity to cultural differences.
-Excellent written/oral communication skills and highly proficient word processing skills.
-Working knowledge of worldwide registration document requirements including ICH guidelines, EMEA requirements and FDA guidelines and requirements.
-Ability to multi-task, deal with competing priorities, meet aggressive timeline expectations.
-Ability to think clearly, get appropriate input from different disciplines as needed, provide focused answers.
-Team player who is cost conscious, adaptable to change, excellent organization skills, quality focused, with proven analytical and problem solving abilities.
Education and/or Experience Required:
-B.S. degree, advanced degree/Life Sciences preferred.
-7-10 years experience in regulatory writing or equivalent within the pharmaceutical industry, including managing 2-3 global registration dossiers
-Experience with contrast medical and imaging modalities preferred.
-Experience with an electronic based document management system.
-Vendor/consultant management experience preferred
Other:
-International travel, generally to European countries required, approx. 15%.
Required Skills:
MEDICAL WRITING, PHARMACEUTICAL MEDICAL WRITING
Join Aerotek Scientific LLCSM, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries are equal opportunity employers.
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Thursday, October 15, 2009
Free Webinar Tonight
| CME Opportunities for Medical Writers | ||||||||||||||||||||||||||||
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Monday, October 12, 2009
Medical Writing Publications Manager Position
Title: Medical Writing Publications Manager
Location: MD Gaithersburg - Corporate Headquarters
Req: 01879
Position Summary:
Major Duties and Responsibilities (including supervising others):
• Ensures the timely presentation/dissemination of clinical data from investigational pipeline products according to budget timelines strategic publication plans and tactical approaches.
• Ensures that strategically aligned scientific communication points are delivered and that statements and conclusions in publications (manuscripts abstracts posters oral presentations etc.) are accurate and supported by appropriate data.
• Oversees the entire publication development process working closely with authors thought leaders medical writers and other cross-functional publication team members.
• Ensures the quality and transparency of clinical publications by maintaining and promoting familiarity with ICMJE CONSORT AMA and other external standards as well as MedImmune’s publication policy and procedures.
• Creates and maintains publication records in the e-publication system and related files in the document management system ensuring that all author feedback and publication versions are archived.
• Leads cross-functional publication development team meetings and communications among team members.
• Participates in the development of strategic publication plans and tactics attends publication planning team meetings.
• Manages contract resources in the development of publications to meet objectives in a cost efficient and timely manner effectively using project management skills.
• Develops and actively manages relationships with journals sponsor congress organizations and publishers; prepares cover letters and response to journal letters and submits publications for review.
• Creates publication timelines and provides regular publication project status reports to Director Publication Writing and to publication planning teams.
• Develops and improves industry best practice in publication management; participates in the preparation or revision of SOPs and WPDs.
• Oversees the maintenance of database of bibliographic references across assigned therapeutic areas.
Experience:
• 5+ years writing/editing publication experience in pharmaceutical industry communications agency or academic setting relevant to clinical publication development.
• Lead author of 8+ clinical/scientific publications or formal medical writing acknowledgment in 8+ clinical publications.
• Previous experience with management of publication-related vendors required; supervisory experience for direct reports a plus
• Strong track record (5+ years) in publication management required.
Special Skills/Abilities:
• Previous experience writing and editing peer-reviewed clinical publications (manuscripts abstracts posters oral presentations review articles etc.) required.
• Demonstrated ability to manage several projects simultaneously.
• Ability to analyze critically and synthesize complex scientific information from a broad range of scientific disciplines and clinical therapeutic areas.
• Ability to think strategically; demonstrated negotiating skills and resourcefulness.
• Demonstrated leadership qualities to gain credibility and influence cross-functional publication teams and external authors and thought leaders; high degree of influencing skills in shaping and developing publication content and wording.
• Demonstrated ability to make effective decisions even in the absence of complete information and when under pressure.
• Demonstrated ability to drive performance—holds others accountable for high standards and clarifies what needs to be accomplished and the consequences for the individual and/or the organization.
• Demonstrated ability to work collaboratively—seeks input and demonstrates an appreciation for diverse views by incorporating them into decisions/proposals.
Educations:
Requirements/Qualifications:
Education:
• MS degree in a biomedical discipline required; doctorate level (PharmD MD or PhD) preferred.
• AMWA BELS and/or ISMPP certification a plus.
CLICK HERE TO APPLY
Location: MD Gaithersburg - Corporate Headquarters
Req: 01879
Position Summary:
Major Duties and Responsibilities (including supervising others):
• Ensures the timely presentation/dissemination of clinical data from investigational pipeline products according to budget timelines strategic publication plans and tactical approaches.
• Ensures that strategically aligned scientific communication points are delivered and that statements and conclusions in publications (manuscripts abstracts posters oral presentations etc.) are accurate and supported by appropriate data.
• Oversees the entire publication development process working closely with authors thought leaders medical writers and other cross-functional publication team members.
• Ensures the quality and transparency of clinical publications by maintaining and promoting familiarity with ICMJE CONSORT AMA and other external standards as well as MedImmune’s publication policy and procedures.
• Creates and maintains publication records in the e-publication system and related files in the document management system ensuring that all author feedback and publication versions are archived.
• Leads cross-functional publication development team meetings and communications among team members.
• Participates in the development of strategic publication plans and tactics attends publication planning team meetings.
• Manages contract resources in the development of publications to meet objectives in a cost efficient and timely manner effectively using project management skills.
• Develops and actively manages relationships with journals sponsor congress organizations and publishers; prepares cover letters and response to journal letters and submits publications for review.
• Creates publication timelines and provides regular publication project status reports to Director Publication Writing and to publication planning teams.
• Develops and improves industry best practice in publication management; participates in the preparation or revision of SOPs and WPDs.
• Oversees the maintenance of database of bibliographic references across assigned therapeutic areas.
Experience:
• 5+ years writing/editing publication experience in pharmaceutical industry communications agency or academic setting relevant to clinical publication development.
• Lead author of 8+ clinical/scientific publications or formal medical writing acknowledgment in 8+ clinical publications.
• Previous experience with management of publication-related vendors required; supervisory experience for direct reports a plus
• Strong track record (5+ years) in publication management required.
Special Skills/Abilities:
• Previous experience writing and editing peer-reviewed clinical publications (manuscripts abstracts posters oral presentations review articles etc.) required.
• Demonstrated ability to manage several projects simultaneously.
• Ability to analyze critically and synthesize complex scientific information from a broad range of scientific disciplines and clinical therapeutic areas.
• Ability to think strategically; demonstrated negotiating skills and resourcefulness.
• Demonstrated leadership qualities to gain credibility and influence cross-functional publication teams and external authors and thought leaders; high degree of influencing skills in shaping and developing publication content and wording.
• Demonstrated ability to make effective decisions even in the absence of complete information and when under pressure.
• Demonstrated ability to drive performance—holds others accountable for high standards and clarifies what needs to be accomplished and the consequences for the individual and/or the organization.
• Demonstrated ability to work collaboratively—seeks input and demonstrates an appreciation for diverse views by incorporating them into decisions/proposals.
Educations:
Requirements/Qualifications:
Education:
• MS degree in a biomedical discipline required; doctorate level (PharmD MD or PhD) preferred.
• AMWA BELS and/or ISMPP certification a plus.
CLICK HERE TO APPLY
Thursday, October 1, 2009
Medical Writing Position in Los Angeles
Scientific Communications Executive
Position Profile
Scientific Communications Executives work with public relations account teams to provide tactical counsel to clients and implement a variety of projects related to the communication of scientific or medical information. They also provide counsel to other healthcare offices within the agency network and assume responsibility for relevant projects and initiatives led by other teams.
Primary Responsibilities
Account/Overall
- Interpret and translate complex clinical or scientific data for lay and science press
- Develop proposals, fact sheets, handbooks, animated tutorials (scripts), web sites/copy, press releases and other materials
- Communicate credibly with professional (e.g., scientific) audiences
- Ensure scientific accuracy of documents other team members prepare
- Instruct staff in the areas of science writing and editing as necessary
- Contribute to the development of strategic client plans (e.g., data communication strategies and tactics)
Client
- Demonstrate a solid understanding of clients’ business and industry (typically pharmaceutical, biotechnology, medical device or other life science industries)
- Provide client counsel on tactical matters, linked to strategic plans and communication of scientific or clinical data
- Interact with clinical/scientific leaders on the client side
- Prepare and deliver tutorials on relevant scientific subjects
- Generate new ideas and opportunities to ensure client program success
- Assist with development of client presentations
Media
- Understand industry issues that directly and indirectly affect the client
- Demonstrate a well-developed knowledge of relevant media (e.g., science magazines, major healthcare reporters)
- Draft media relations materials (see above)
Qualifications
Education
Ph.D. in life sciences (biology, biochemistry, molecular biology, physiology, genetics, biophysics, etc.).
Professional Experience/Requirements
Proficiency with Word, PowerPoint, Excel
Excellent writing and speaking/presentation skills
1-2 years of related professional experience (PR agency or pharmaceutical/biotechnology company preferred); or
1-2 years continuing medical education/medical advertising experience; or
1-2 years experience as a journalist
Contact:
Frank Orrico, PhD
Senior Vice President, Director of Scientific Communications
P 312.397.6632
forrico (at) webershandwick.com
Position Profile
Scientific Communications Executives work with public relations account teams to provide tactical counsel to clients and implement a variety of projects related to the communication of scientific or medical information. They also provide counsel to other healthcare offices within the agency network and assume responsibility for relevant projects and initiatives led by other teams.
Primary Responsibilities
Account/Overall
- Interpret and translate complex clinical or scientific data for lay and science press
- Develop proposals, fact sheets, handbooks, animated tutorials (scripts), web sites/copy, press releases and other materials
- Communicate credibly with professional (e.g., scientific) audiences
- Ensure scientific accuracy of documents other team members prepare
- Instruct staff in the areas of science writing and editing as necessary
- Contribute to the development of strategic client plans (e.g., data communication strategies and tactics)
Client
- Demonstrate a solid understanding of clients’ business and industry (typically pharmaceutical, biotechnology, medical device or other life science industries)
- Provide client counsel on tactical matters, linked to strategic plans and communication of scientific or clinical data
- Interact with clinical/scientific leaders on the client side
- Prepare and deliver tutorials on relevant scientific subjects
- Generate new ideas and opportunities to ensure client program success
- Assist with development of client presentations
Media
- Understand industry issues that directly and indirectly affect the client
- Demonstrate a well-developed knowledge of relevant media (e.g., science magazines, major healthcare reporters)
- Draft media relations materials (see above)
Qualifications
Education
Ph.D. in life sciences (biology, biochemistry, molecular biology, physiology, genetics, biophysics, etc.).
Professional Experience/Requirements
Proficiency with Word, PowerPoint, Excel
Excellent writing and speaking/presentation skills
1-2 years of related professional experience (PR agency or pharmaceutical/biotechnology company preferred); or
1-2 years continuing medical education/medical advertising experience; or
1-2 years experience as a journalist
Contact:
Frank Orrico, PhD
Senior Vice President, Director of Scientific Communications
P 312.397.6632
forrico (at) webershandwick.com
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