| November 23, 2008 | Vol. 1 No. 8 Published by Biotech Ink, LLC, and Word Angel Document Design Solutions | |
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Open Medical Writing Staff and Contract Jobs |
| CMC Editor I
South San Francisco, CA |
Job title: CMC Editor I 361853
Client: Genentech
Location: South San Francisco , CA 94080
Duration: December 01, 2008 through May 1, 2009 (extendable contract)
Shift: Monday to Friday (8 am to 5 pm)
DUTIES
The CMC Editor plays an integral part in the preparation of regulatory submissions at Genentech. He or she copy edits, formats, and coordinates the review of the CMC sections of regulatory documents to ensure the timely submission of high-quality applications to regulatory agencies.
In this role, he or she represents the CMC Editing department on cross-functional CMC teams; works closely with Regulatory Affairs CMC representatives; and communicates with authors and other team members to manage the review, adjudication, revision, and internal approval of draft documents. He or she copy edits complex text for clarity, consistency, grammar, punctuation, and adherence to house styles; edits and formats detailed tables; and provides authors with document training and support.
SKILLS
Three or more years of recent technical copy editing experience.
Thorough knowledge of grammar, punctuation, and usage as well as familiarity with technical or scientific language. Excellent organizational and time management skills and a tenacious approach to detail. The ability to manage multiple, often lengthy, documents simultaneously; communicate clearly and professionally, both orally and in writing; meet demanding deadlines; and collaborate with scientists and other subject matter experts. Advanced word-processing skills (Microsoft Word).
EDUCATION
BS or BA in biology, chemistry, English, or journalism or the equivalent.
Radiants system, Inc. 107B Corporate Boulevard South plainfield, NJ 07080 Radiant is preferred (Direct) vendor to several other Fortune 500 clients (HP, AT&T, Motorola, Novartis, Pfizer, Sanofi-Aventis, Caterpillar, Genentech, GE, Abbott, and Avaya, Lucent etc.). To know us a little better, please visit us at www.radiants.com |
| Regulatory Medical Writer
Connecticut |
12 month contract
Connecticut
$45-55/hr W2.
Connecticut based Pharmaceutical firm has a 12 month engagement for a talented Regulatory Medical Writer. Qualified candidates will have a Masters Degree in Science and 5+ years of Regulatory Medical Writing. Experience and knowledge of key concepts, practices, and procedures related to clinical research, development of clinical study reports, and medical research sections of U.S. New Drug Applications is required. Experience interacting with CRO's and various levels of clinical research is also desired.
Contact
Stephen Herrick
Recruiter
Kforce Technology Staffing
3 Corporate Drive, Suite 214
Shelton, CT 06484
(203) 225-1708
Fax: 203 225 1770 |
| Medical Writer, Regulatory
Stamford, CT |
Our Pharmaceutical client in Stamford, CT is looking for a Medical Writer for a 12 month contract. Candidate will be responsible for writing and/or editing clinical study reports, medical research
sections of regulatory submissions (e.g. ISS, ISE, clinical summaries), and clinical study reports for submission to the FDA.
Must work onsite a minimum of 3 days per week in Stamford,CT. The balance of the week may be worked remotely.
Requires a minimum of a Master's Degree in an associated scientific discipline and at least 5 years of recent regulatory writing. Will interact with CRO's and multiple levels of the clinical research
organization.
Reports to Executive Director, Scientific Communications.
Experience/Skills
- 5+ years of recent experience in regulartory, specifically, submissions to the FDA and clinical study reports
- Working knowledge of key concepts, practices, and procedures related to clinical research and development of clinical study reports, and medical research sections of U.S. Drug Applicaions is required
- Extensive experience and judgment to plan and accomplish goals
- Interact with multiple levels of the clinical research
organization.
Education
Master's degree in an associated scientific discipline
If qualified, please send updated resume in Word format.
Contact
Dilpreet Kaur
Search Consultant
Celerity Technology Services
a division of Howard-Sloan Professional Search 261 Madison Avenue, 11th Floor New York, NY 10016 Phone 412-490-7948 Fax 212-869-7999 www.celerityts.com
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| Senior Medical Writer
Northern New Jersey |
Location: Northern NJ (3 days on-site, 2 days off-site/home office) (Near Hackensack)
Job Purpose
We are seeking a senior level medical writer to support Phase 1 / Pharmacokinetic studies involving diabetes. This is a full-time 3 month contract position with possibility of renewal based on candidate performance and company need.
Key Responsibilities
1) Discuss, develop, produce, revise and/or update protocols and clinical study reports for preclinical and clinical studies
2) Responsible for developing IB's, components of Investigational New Drug, Clinical Trial Authorization, New Drug Application submissions, regulatory responses, and other clinical/regulatory documents.
3) Provide support to the assigned clinical development team to ensure clinical/regulatory document development needs and department standards are met, while completing projects within established schedules/timelines.
4) Mentor and train junior medical writers as required
5) Manage outside contractors as required
6) Facilitate conflict resolution across multi-disciplinary teams
Requirements
Minimum Bachelor's degree (BSN/MS/PhD/PharmD preferred) required in biological, nursing or medical sciences
5+ years of relevant medical writing experience including protocol writing
Project Management experience with a strong track record of planning and organizational skills with minimal supervision
Experience in pharmaceutical industry Phase I-II pharmacokinetic/pharmacodynamic research is required
Knowledge of the development, regulatory, quality, and compliance environment within the pharmaceutical and marketing environment
Strong interpersonal and communication skills
Familiarity with ICH and AMA guidelines
Proficiency in MSWord, Excel, and PowerPoint
Compensation
$85-100 per hour. Reasonable travel expenses will be reimbursed.
Contact
Shawn Varrin, M.Sc., M.B.A.
President
VinCro Clinical Management Services
6813 Sunset Blvd.,
Ottawa, Ontario, Canada
K4P 1M6
Ph - 613-526-4267
Fax 613-526-6200
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| Medical Editor
Northern New Jersey |
Location: Northern NJ (3 days on-site, 2 days off-site/home office) (Near Hackensack)
Job Purpose
We are seeking a medical editor to proofread and edit research protocols, clinical study reports, medical writing templates as well as check IB?s, IND, CTA, NDA, regulatory responses and other clinical/regulatory documents for accuracy and flow. This is a full-time 3 month contract position.
Key Responsibilities
1) Responsible for medical, technical and traditional editing and proofreading by ensuring correct grammar, spelling, and typography of approved documents
2) Preparation of medical writing templates
3) Proofread and edit protocols and clinical study reports for preclinical and clinical studies; Investigator?s Brochures; components of Investigational New Drug Applications, Clinical Trial Authorization, and New Drug Application submissions; regulatory responses; and other clinical/regulatory documents
4) Provide editorial support to the assigned clinical development team to ensure that clinical/regulatory document development needs and department standards are met, while completing projects within established schedules/timelines
5) May supervise and manage medical editing consultants in the absence of or as directed by Senior Manager, Medical Writing or Senior Director, Medical Writing
Requirements
Minimum Bachelor's Degree in Communication, Physical Sciences, Medical Sciences, advanced degree an asset
2 years of pharmaceutical industry experience in regulatory, medical writing or clinical development arenas
Strong interpersonal and communication skills
Familiarity with eCTD, ICH and AMA guidelines
Proficiency in MSWord, Excel, and PowerPoint
Compensation
$45-65 per hour. Reasonable travel expenses will be reimbursed.
Contact
Shawn Varrin, M.Sc., M.B.A.
President
VinCro Clinical Management Services
6813 Sunset Blvd.,
Ottawa, Ontario, Canada
K4P 1M6
Ph - 613-526-4267
Fax 613-526-6200
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| Editorial Director
New Jersey |
We are looking to hire a person to lead our editorial group of four writers, one copy editor, and two editorial assistants. The qualifications are as follows:
o Advanced degree: PharmD, PhD or Master's degree in a biomedical science, MD
o 5+ years of experience at a medical communications agency (not pharmaceutical company, ad agency, PR firm, or CRO)
o 5+ years of experience managing an editorial group, including:
- Recruiting qualified full-time medical writers
- Managing staff of writers and editors, including development, reviews, setting performance objectives and monitoring progress
- Managing editorial assignments on a weekly basis
- Managing resource needs both short- and long-term
- Identifying and managing freelance writing resources, including negotiating fees and timelines
- Reviewing content for overall accuracy, satisfaction of client objectives, and adherence to style guidelines
- Overseeing proofreading and copy-editing services, including setting and maintaining internal and external style guidelines
- Managing editorial services for a variety of programs, including events (advisory boards, roundtables, dinner meetings, symposia), print (journal articles, congress presentations, monographs, supplements), media (webcasts, CD-ROM), and strategic planning (publication plans, communication plans)
- Taking on writing assignments as needed
- Contributing to sales pitches, capability presentations, and account development
- Interacting with account services, project management, graphic services, sales, and finance
o Must be able to meet deadlines and work well under pressure
o Therapeutic category experience (cardiovascular, diabetes, vaccines, infectious disease, respiratory diseases, virology) plus a willingness and ability to learn new categories
o Ability to lead editorial group to maintain standards of excellence in writing, internal and external communications, client and KOL interactions, and internal teamwork.
o Person will work full-time on-site in our Collingswood office
o Some travel required.
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| Medical Writer
Kenilworth, NJ |
Duration: 6 Months
Minimum 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.
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.
Duties include
- 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.
- 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 also serve as a technical expert for the department and represent the department in cross-functional decision making teams and committees.
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| Medical Director
New York City |
The Medical Director is responsible for the review and development of all scientific content within a discipline and across multiple therapeutic areas. The Medical Director works independently, has greater than 5 years of experience in medical education or relevant experience and is fully responsible for all programs and Assistant/Associate Medical Directors within their discipline. The Medical Director is a highly visible individual engaging in frequent interaction with clients and internal staff. Primary responsibilities include review of scientific content for enduring materials, development of publication strategies, positioning of key data, communication with program directors, clients, key opinion leaders and faculty and leadership in business development. Some travel is required
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DISCLAIMER: Biotech Ink, LLC, and the Biotech Ink Insider provide the Insider jobs list on an "as-submitted basis," and neither assumes responsibility for, nor guarantees the quality or accuracy of, any listing or response. All listings are provided as a free service and courtesy to subscribers and users, and users assume all risk in using the information in the Insider.
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