Thank you everyone, for your support: 2012 in review

The WordPress.com stats helper monkeys prepared a 2012 annual report for this blog.

Here’s an excerpt:

600 people reached the top of Mt. Everest in 2012. This blog got about 4,800 views in 2012. If every person who reached the top of Mt. Everest viewed this blog, it would have taken 8 years to get that many views.

Click here to see the complete report.

Manager of Medical Writing opening

Manager of Medical Writing

Education and Related Experience

BS degree or higher in a scientific field with 10 years of experience in pharmaceutical medical writing.

 

Manages outsourced medical writing projects, primarily clinical submission documents for the FDA and other regulatory authorities worldwide. This includes but is not limited to:

-     Review of deliverables against quality and in-house standards.

-     Coordination of development activities with the company Operations Team members.

-     Issue resolution.

-     Quality control of non-published and published deliverables.

-     Vendor assessment and day-to-day vendor oversight.

-     Project needs assessment (time and materials).

-     Timeline management.

-     Training of external vendors on company SOPs and business processes.

-     Budgeting and contract management.

-     Dispute resolution with vendors.

10%

•    Authors and/or edits key regulatory documents as needed, including but not limited to protocols, clinical study reports, investigator’s brochures, annual reports, briefing packages, and integrated data reports.

10%

•    Represents Medical Writing on project teams, including but not limited to attendance at team meetings, communication of project status and critical path issues, and provision of projected and actual dates to project management team for input into the timeline management system.

10%

•    Provides relevant and timely project information to the functional area head, ensuring that adequate coverage of medical writing needs is maintained in accordance with the company’s goals and objectives.

5%

•    Adheres to and helps maintain departmental SOPs and working practices, including the necessary model documents and style guidelines, for standardized processes and style expectations across projects.

5%

•    Provides backup support to other Medical Writing Managers.

 

Knowledge

•    Solid knowledge of the clinical development process, good clinical practices, and the medical writing process.

•    Solid understanding of the requirements of regulatory writing, including ICH guidelines.

 

 

Skills

•    Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook) and Adobe Acrobat.

•    Strong communication skills.

•    Knowledge of how/when to apply organizational policy and/or procedures to a variety of situations.

Contact Edward if interested:

Edward A. Giorgi

Clinical Research Recruiter

Medical Staffinf Network Healthcare, LLC

5515 Security Lane, Suite 1109, Rockville, MD 20852

W: 301-945-9056 |C: 804-496-8886| F:  301-468-3485| edwardgiorgi@msnhealth.com

 

Senior Medical Writer opening in Rockville MD

 

Senior Medical Writer

Location: Rockville, MD

Profession: Clinical Research

Specialty: Medical Writing

Salary: Open

 

Our client is a leading, global pharmaceutical company seeking to add a qualified Senior Medical Writer to their team in Rockville, MD!

 

The Senior Medical Writer will be responsible for providing management and oversight of contracted staff in the preparation of clinical research submission to the United States Food and Drug Administration (FDA) and other regulatory authorities worldwide in support of investigational new drug and marketing authorization applications.  This includes protocols, phase 1 to 4 clinical study reports, integrated summaries (eCTD Module 2 and 5), annual reports, investigator´s brochures (IBs), etc.  Will also author and edit briefing documents, and manuscripts and abstracts.  Serve as the functional area representative on a therapeutic project team.  Supervise writing contractors, as well as mentor and review the work of Medical Writers I and II.

 

Job Requirements

·          Bachelor’s Degree in a relevant field

·         10 years of medical writing experience within pharmaceutical clinical trials

·         Must have experience with global eCTD submissions

·          Experienced in supervising other medical writers

·         Excellent oral and written communication skills

If interested, contact Edward at:

Edward A. Giorgi

Clinical Research Recruiter

Medical Staffinf Network Healthcare, LLC

5515 Security Lane, Suite 1109, Rockville, MD 20852

W: 301-945-9056 |C: 804-496-8886| F:  301-468-3485| edwardgiorgi@msnhealth.com

 

Comment: An Introduction to Common Bacterial Skin Disorders, a guest post by Valerie Johnston

Your skin is your body’s first defense against bacteria. Skin that is healthy is effective in protecting the rest of the body against infection from bacteria. However, skin itself is a vulnerable organ and skin disorders caused by bacteria are not all that uncommon. While most skin disorders are not serious, proper treatment is necessary in order to alleviate associated symptoms.

There are two types of bacteria—Streptococcus and Staphylococcus aureus—that are the primary culprits of bacterial skin disorders. There are also several types of skin bacterial infections that are more common than others, including cellulitis, folliculitis, furuncles and carbuncles, erysipelas, erythrasma, and impetigo.

Cellulitis

Cellulitis is a skin disorder that, unfortunately, can develop on normal skin that does not have any scrapes, cuts, or other wounds. It is an infection of the skin’s deeper layers, including the subcutaneous tissue and the dermis. Symptoms may include red, swollen skin that feels warm and is painful. Swollen lymph nodes and red streaks near the affected area may also appear. A person with cellulitis may also experience fatigue, fever, and chills.

Folliculitis

As the name suggests, folliculitis is a bacterial infection of the hair follicles. This type of skin disorder appears as small, red bumps and, in some cases, the bumps may be filled with pus. Standard folliculitis should not be confused with “hot tub folliculitis,” which is a skin disorder that is contracted in hot tubs or pools. Folliculitis is caused by S. aureus, while hot tub folliculitis is caused by Pseudomonas aeruginosa.

Furuncles and Carbuncles

Furuncles and carbuncles are follicular infections. Furuncle is a more extensive infection than folliculitis since it affects both the follicles and the sebaceous gland. This type of bacterial skin disorder commonly affects the face, neck, buttocks, and armpits. Symptoms include small, red nodules that may be painful. A carbuncle is characterized by multiple furuncles that are grouped together. This type of skin disorder may appear as a large, red nodule that may include areas of pus beneath the skin’s surface. The area may feel hot.

Erysipelas

This skin disorder is considered a superficial skin infection that usually involves the lymphatic system. This condition commonly occurs in areas of the body where there is an obstruction in the lymphatic system. Most cases now involve symptoms in the lower extremities of the body. At first, symptoms such as fatigue, fever, vomiting and chills may be experienced. These symptoms are usually followed by a skin rash.

Erythrasma

This bacterial skin disorder occurs where the skin comes into contact with skin, such as in the armpits, between the toes, and in the groin area. The condition is commonly mistaken for a fungal infection since its dark appearance is similar to fungal infections such as jock itch. If symptoms are not reduced with anti-fungal treatments, it is important to seek a proper diagnosis from your doctor.

Impetigo

The bacterial skin infection known as impetigo affects the skin’s top layer (epidermis). This infection appears as a crust that is honey-colored. It most often occurs where there are minor breaks in the skin’s surface. Cuts, insect bites, or skin conditions such as scabies, eczema, herpes, or chickenpox can also make a person more susceptible to contracting impetigo.

When to See Your Doctor

Anytime that you notice aberrations in your skin that you haven’t experienced before, it is a good idea to schedule an appointment with your doctor. While most skin conditions can be resolved in a relatively short period of time, it is better to be safe than sorry. It’s important to not risk spreading the infection to others, and to ensure that your symptoms do not become worse. With a proper diagnose, you will be able to benefit from the most effective form of treatment.

Image: Impetigo, from bupa.co.uk

Valerie Johnston is a health and fitness writer located in East Texas. With ambitions of one day running a marathon, writing for Healthline.com ensures she keeps up-to-date on all of the latest health and fitness news.

Comment: Diabetes treatment and risks, a guest post by Elizabeth Carrollton

Diabetes refers to a condition that occurs when blood sugar levels are higher than normal, which is around 90 on a glucometer reading. The disease classifies as a metabolic disorder, since it affects the way in which glucose is converted into energy.

Individuals who develop or are born with diabetes are more at risk for various medical conditions. Kidney problems are oftentimes synonymous with diabetes. In some cases, the kidneys do not work as well as they should. In other cases, the kidneys fail completely. Other problems include nerve damage, sores, eye problems and infection.

Cardiovascular problems are another serious problem linked to the disease. According to the American Diabetes Association (ADA), patients with the disease are more than twice as likely to develop heart problems. Two out of three people living with the metabolic disorder end up dying from a heart attack or a stroke, and patients with diabetes also experience an earlier onset of heart disease or stroke.

Unfortunately, certain medications to treat diabetes are also associated with heart disease, and stroke. Actos and Avandia are two name brand drugs used to treat hyperglycemia that have these risky side effects. Due to this, several thousand patients have filed an Actos Lawsuit. In the U.S., the FDA requires that patients may only take Avandia if they have already been on it, or if they have not had any signs of improved glucose levels while taking other medicines. In some parts of the U.S,  both of these medications have been taken off the shelves completely.

The best way of managing heart disease and diabetes is to maintain a healthy weight, eat nutritious food such as fruits and vegetables, and stick to an exercise program.

Elizabeth Carrollton writes about defective medical devices and dangerous drugs for Drugwatch.com.

Summertime is here

Everyone,

It is that time of year when people have travel plans. They leave the hot and humid discomfort of an east-coast city and head to cooler climes. This is what I’m about to do. As a consequence, I won’t be posting new blogs until September.

I hope that everyone has a wonderful summer, and expect to see something new in this space come the first week of September.

Adherence to a low-risk, healthy lifestyle and risk of sudden cardiac death among women

Sudden cardiac death (SCD) is responsible for over half of all deaths due to heart disease. Unfortunately, SCD is usually the first manifestation of heart disease, especially among women.  At the moment, the most popular way of preventing SCD is to implant defibrillators into patients with severe left ventricular dysfunction. The problem with this approach is that only 25% to 30% of SCDs occur among this high-risk subgroup. Clearly, prevention strategies are needed to reach lower risk populations.

With this in mind, the authors analyzed data from the Nurses Health Study that was begun in 1976, when 12,700 female nurses aged 30 to 35 years provided information on lifestyle and medical history. The authors analyzed data from June 1976 to June 2010 to determine what role modifiable lifestyle factors, such as smoking, BMI, diet, and alcohol intake played in preventing SCD.

There was a clear association between healthy lifestyle – including no smoking, a BMI less than 25, a mediterranean diet, and moderate alcohol intake – and lower risk of SCD.

To read more, click here, or go to JAMA, July 6, 2011 – Vol. 306, No. 1, pp. 62-69.

-–Cynthia Haggard is a medical writer by day, and a novelist by night..  To see more about her medical writing business, go to clarifyingconcepts. To see more about her creative writing, go to spunstories.com (c) 2011 All rights reserved.