| 22 July 2011 Published by Biotech Ink, LLC | Vol 4 No 14 |
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Inside the Insider | |
Open Jobs and Contract Opportunities
Regulatory Affairs Specialist (Medical Writer); Minneapolis, MN
Medical Writer, Publications; Plainsboro, NJ
Medical Writer, Medical Affairs; South San Francsico, CA |
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Jobs and Contract Opportunities |
 The jobs listed in the Biotech Ink Insider weekly newsletter come to Susan Caldwell mostly by word-of-mouth and contact with hiring managers and recruiters.
The Insider lists job and contract opportunities worldwide that are closely related to medical writing, or that have a strong writing role, regardless of their titles. Examples include biostatistician, director of clinical research, and other clinical research titles. If you receive calls about staff or contract medical writing or related positions that you aren't interested in, please forward the job information to Susan Caldwell at caldwell@biotechink.com. We'd be delighted to publish such positions in the next issue of the Insider. |
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Regulatory Affairs Specialist (Medical Writer) Minneapolis, MN |
A Major Pharmaceutical Company is currently seeking a Regulatory Affairs Specialist for their location in Minneapolis, MN
In-house, relocation candidates OK; 4-month extendable contract
Description:
- Medical Writer is needed to write a Spinal Cord Stimulation accessory kit Clinical Evidence Report for submission to European Regulatory Authority.
- Ensure compliance to the FDA Quality System Regulations, European Requirements, and other regulatory requirements.,
- Prepare required documentation [510(k)s, technical files, dossiers] for domestic and foreign submissions and registrations.
- Attend design review meetings regarding design controls. Interacts with other departments to assist in determining the Regulatory pathways required for products that are in the development process.,
- Research medical literature, regulatory documents and related information for inclusion into clinical articles and regulatory submissions and for evaluating manuscripts for accuracy, completeness, and adherence to regulatory requirements.
- Qualifications:
- This person must have excellent understanding of clinical research processes and be able to analyze clinical risks and benefits of a new product.
- Person will work with engineers responsible for design, validation/testing, and risk analysis of new product and to compile their contributions to the report and will evaluate the clinical risks of the new product in close collaboration with Regulatory Affairs personnel writing the US and European submissions and the Clinical Core Team member.
- Person must be skilled in review and selection of relevant literature for inclusion in CER and able to summarize clinical data from literature articles.
Education Level: Undergraduate Degree
Industry Experience: Greater than 5 Years
Written Communication: Good Legible Handwriting
Education Level: Post Graduate Degree, Master of Science
Contact:
Amy E. Fink, Clinical Recruiter
MedFocus, LLC
8600 W. Bryn Mawr, Suite 700
Chicago, IL 60631
O:(773) 632-1785
F:(866)439-9491
M:(847)636-0770
afink@medfocus.com |
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Medical Writer, Publications Plainsboro, NJ |
Job Description / Requirements:
- Advanced degree - MD, PharmD, or PhD; Experience working for a publication agency or a pharmaceutical company preferred
- Medical writing experience with a minimum of 2 years experience with the writing focus on scientific publications
- Demonstrated strong writing skills as evidenced by good quality writing in 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 journals.
- 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.
- Distill, share and apply publication best practices to ensure publications are developed with the highest degree of integrity, quality and transparency, thus enabling the safe and appropriate use of medicines.
Contact:
Amy E. Fink, Clinical Recruiter
MedFocus, LLC
8600 W. Bryn Mawr, Suite 700
Chicago, IL 60631
O:(773) 632-1785
F:(866)439-9491
M:(847)636-0770
afink@medfocus.com
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Medical Writer, Medical Affairs South San Francisco, CA |
In-house, potential for contract-to-hire; 6-month extendable contract; must be local to the area OR relocation from West Coast only
Responsibilities:
- The Medical Writer is responsible for writing and editing high-quality manuscripts, posters, presentations, review articles, slide kits, and other educational materials mostly from clinical study data
- Proofreading layouts of publication materials, including galleys
- Verifying scientific accuracy of publications by data checking information against original source
- Editing and formatting slide presentations
- Facilitate comment resolution with contributing authors/reviewers
- Participate actively in monthly meetings providing relevant publication and communication updates to the other team members
- Prepare documents according to specific guidelines mandated by the journal or publishing agency
- Provide review and substantive editing of documents
Requirements:
- A minimum of three years of experience writing/preparing abstracts, manuscripts, and reviews for clinical trials for a pharmaceutical, biotechnology, contract research company, medical education company, medical communication company or advertising agency
- MS or higher degree in a scientific discipline
- Must have a strong scientific/clinical background.
- Prior experience in the therapeutic areas of nephrology is highly desirable
- Skilled in MS Office (excellent word processing skills), tools managing bibliographical references (Endnote) and presentation (PowerPoint)
- Experience in data handling and data analysis
- Attention to Detail: produces accurate work, even when under pressure; checks the accuracy of information before using it or passing it on to others.
- Ability to work within tight timelines while maintaining accuracy.
- Must have excellent writing, editing, and oral communication skills.
- Ability to research and review clinical content effectively and translate information into clear and concise messages using AMA style in the English language.
- Ability to successfully organize and manage multiple simultaneous projects from conception to completion, working collaboratively with other members of the Medical Affairs team.
Contact:
Amy E. Fink, Clinical Recruiter
MedFocus, LLC
8600 W. Bryn Mawr, Suite 700
Chicago, IL 60631
O:(773) 632-1785
F:(866)439-9491
M:(847)636-0770
afink@medfocus.com
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