By Don Monroe, on April 4th, 2013 Job Title:
Medical Writer (BLA experience)
Full time, location not specified
Job Description:
Our device sponsor client is looking for a medical writer to join their team.
Responsibilities include:
- Lead/oversee medical writing efforts for clinical portions of a BLA product currently in Phase III, working closely with Clinical and Regulatory groups.
- Approach issues from a number of perspectives, summarizing data to draw a conclusion. Ensure all documents are well organized, accurate, consistent, and in compliance with applicable company SOP’s and regulations.
- Systematically perform activities in a timely and accurate manner.
Candidate should have a BA/BS, preferably in the field of (bio-medical) science. This position will be full time for 2013, and will continue into at least first half of 2014.
Contact:
Laura Walton – lwalton@aerotek.com
By Don Monroe, on April 4th, 2013 Job Title:
Team/Collaborative Writer
Freelance, Wherever You Are — Online & Skype
Job Description:
Write a 500 to 1000 words “audition piece” for a “research-based self-help book” & website focused on the “collaborative nature” (“team nature”) of us human beings.
The research support for this project includes: Evolutionary Psychology; Child Development (primarily Attachment Theory) Research; Interpersonal Neurobiology; Self Determination Theory and Social Psychology in general. (You don’t need to be familiar with any of this research, but you do need to be seriously interested in brain science, social science, cognitive science, attention science, any science related in some way to “human nature science”)
We provide audios (45-60 mins) outlining-developing the “raw material”
for your audition piece, plus optional follow up interviews to ask questions and check out your ideas (90 minutes max).
We will pay for the audition piece.
* In your application specify your bid. We recommend you quote us a fee of 20 to 50% of your usual fee. We think the possibility of working with us on the development of this project (and possible future projects) is a valuable enough opportunity for you to offer a
reduced fee for this audition piece
* If you have substantial demonstrated science writing success for a broad audience (especially successful book), don’t hesitate to quote us your going rate for doing this audition piece if you would not otherwise apply.
* If you’re an unpublished writer (or very limited published work) you have a better chance of being chosen for the audition if you agree do the audition for nominal or no pay.
Full Description of our “Audition Process” available upon request.
Contact: tsoul9@yahoo.com
By Don Monroe, on March 19th, 2013 Job Title:
Regulatory Medical Writer
Full Time, Homebased, however local to PA
POSITION SUMMARY
The Medical Writer is responsible for the management and preparation of a variety of clinical documents including protocols, clinical study reports, narratives, and investigator brochures for Phase I to IV clinical trials. The Medical Writer is expected to deliver high quality regulatory documents that meet ICH standards, FDA and EMEA (if necessary) guidelines, project timelines, and client specifications.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Writes and/or edits clinical study reports (CSRs), investigator brochures, informed consent forms, patient information, clinical summary documents including Integrated Summaries of Safety and Efficacy, study protocols, and clinical/preclinical sections of INDs, NDAs, etc., in accordance with FDA and ICH guidelines.
- Serves as the primary contact for the customer and the sponsor (if not the same entity) for all project-specific medical writing tasks awarded to company.
- Participates in the development of scientific manuscripts and abstracts describing clinical/preclinical study data, as well as slide and poster presentations.
- In cooperation with the Project Manager attends meetings and teleconferences with the study sponsor, clinical project team and other reviewers to understand and resolve the initial requirements to the document(s), and any further comments and issues.
- Performs quality control review of medical documents.
- Assists in developing strategies for organizing and preparing regulatory documents.
- Converts CSRs, appendices, and other regulatory documents to eCTD submission format.
QUALIFICATIONS
- BS/BA in life sciences or health-related discipline; PhD, PharmD, or advanced degree in a life science strongly preferred.
- Minimum 2 years medical writing experience at a biopharmaceutical company, CRO, or university medical center compiling clinical study reports (CSRs), protocols, and clinical summaries.
- Demonstrated knowledge of scientific/medical terminology and principles as well as domestic/international regulatory requirements.
- Must possess sound scientific and clinical judgment and be able to convey complex issues effectively through written and oral communication.
- Has significant oncology experience (or other complex therapeutic area experience)
Contact: Nicole Ambrose, nambrose@aerotek.com
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