The following excellent career opportunities were posted this week at DNAjobs.com. For each position, I have listed a short description and a link for more information.

I have also included an article by Cindy Kraft, Certified Career Management Coach, titled "5 Mistakes That Can Kill Your Job Search".

As always, I wish you tremendous success in your searching!

Jason

Medical Writer (New Jersey)

- Writing sections of Clinical Trial Reports, NDAs or other regulatory summary documents, and a variety of other clinical research related documents.
- Identifying and organizing materials, and interpreting data in preparing the above-referenced documents.
- Additionally, assisting in establishing the format and content of the above-referenced documents, ensuring adherence to regulatory guidelines.
- BS/BA in Life Sciences required.
- Minimum 2 years experience in scientific environment, in a pharmaceutical or CRO environment necessary.
- Medical writing experience and familiarity with ICH-compliant study reports necessary.

Click here for more information.

Director of Parentage Testing (Tennessee)

The Director of Parentage Testing is a technical management position within MPLN. The Director is responsible for the daily activities and productivity of the Parentage Testing Laboratory, and its technicians. In addition, the Director participates in management level planning and decision making processes within the MPLN organization. The Director is expected to direct or conduct on-going parentage testing/human ID R&D activities, and would preferably be willing to participate also in the molecular clinical R&D activities of MPLN. The successful applicant for Director would have a Ph. D. in a relevant field, and would preferably have considerable experience with nucleic acids, and the PCR process.

Click here for more information.

Medical Director (Boston, MA or Raleigh, NC)

One of the largest CROs in the world is looking for a top notch Medical Director to develop and implement new research clinical programs, monitor clinical trials, provide guidance for clinical protocol, and collaborate with other departments. Requirements:
·Medical Degree and Board Certified or Board Eligible in Rheumatology
·2+ years of clinical trials experience in pharma/biotech/CRO industry
·Experience with medical service area and medical safety
·Experience with direct trials
Compensation includes competitive salary of $140,000 -$180,000, plus performance bonus, stocks & company benefits.

Click here for more information.

Clinical Pharmacologist (Florida)

Position Description: Develops strategies for clinical pharmacology study requirements as part of overall drug development plan. Designs protocols for pharmacological studies and prepares clinical pharmacology sections of NDA's.
Position Requirements:
·M.D. with Clinical Pharmacology specialization or Ph.D. in Clinical Pharmacology
·Minimum 5 years of drug development experience, preferably with a pharmaceutical company. Will consider academic and CRO experience.
·Familiarity with standard protocols for clinical pharmacology studies, including first-in-man, drug interactions and pk/pd studies
·Clinical specialty area or excellent knowledge base in oncology, CNS, and/or respiratory is preferred

Click here for more information.

Pharmacokineticist (Florida)

Position Description: Designs and analyzes clinical pharmacology studies. Estimates the dose and regimen for first-in-man studies.
Position Requirements:
- Ph.D. in Pharmacokinetics. Will consider a Pharm.D.
- Minimum 3 years drug development experience
- Familiar with strategies for estimating doses in first-in-man studies
- Experience with pop-pk modeling techniques using Nonmem or WinNonmix
- Familiar with use of modeling and simulation techniques for optimizing dose and regimens
- Proficient in use of WinNonlin, WinNonmix, Nonmem, Trial Simulator or equivalent

Click here for more information.

Director of Pharmacovigilence (Florida)

Position Description: Responsible for Serious Adverse Event (SAE) management, medical review of final reports and NDA's, and SAE reporting. Responsible for receipt, collection, processing, evaluation and reporting of adverse event reports.
Position Requirements:
- M.D. degree or Ph.D. in Clinical Pharmacology
- Minimum 5 years pharmaceutical or related contract research organization (CRO) experience, including management of safety reporting
- Knowledge of global pharmacovigilence regulatory requirements
- Computer literate with good knowledge of SAE reporting systems, and coding systems such as MedDRA and CoStart

Click here for more information.

Contract Technical Writer (Massachusetts)

Writes/edits technical copy for product operation and service manuals. Focuses on incorporating input from Engineers, distilling very technical information for a wider audience. Gathers information/materials from a variety of resources, and pulls it all together into one document. Candidate must be familiar with Pagemaker. Responsibilities to help accomplish this goal the candidate will write and update text for service/operation manuals. Meets with engineers to gain understanding of how product works. Meets with Product Managers to gain understanding of products. Coordinate the review of service manuals, run demo programs on the instruments in effort to familiarize oneself with product Research information about a technology, application, chemistry, or type of product that he/she is writing about.

Click here for more information.

Director of Clinical Oncology (Maryland)

Join a leader in genomic research as the Director of Clinical Oncology. This position will provide input to project teams during pre-IND development. Responsible for managing the design, planning, execution, interpretation, and communication of clinical trials/research results. The Director will recruit investigators, negotiate study designs/budgets, monitor programs for safety, approve clinical protocols, data collection systems and final reports. REQUIREMENTS:
- Medical Degree; Board Eligible or Certified in oncology
- 5+ years industry experience
- Past experience in developing methods, techniques, and evaluation criteria
- Excellent knowledge of FDA regulatory requirements and documentation

Click here for more information.

Medical Director for Clinical Operations (Massachusetts)

Join a leader in neurological medical devices as the Medical Director for Clinical Operations. This position offers a Board Eligible or Board Certified Neurologist or Physiatrist an opportunity to manage the day-to-day clinical operations for this developer of neurological diagnostic and therapeutic solutions. In addition to managing the clinical support staff, this position will assist in new product development, basic research, and interact/support the sales, marketing and customer support departments. REQUIREMENTS:
- Medical Degree; Board Eligible or Certified Neurologist or Physiatrist
- Excellent understanding of never conduction and electromyography techniques
- Ability to work with external clinical and scientific advisors

Click here for more information.

Regulatory Affairs Specialist (Minnesota)

Our client, a leader in the medical device industry, has an immediate opening for a Regulatory Affairs Specialist. This position requires a person who can work independently to prepare US and international regulatory submissions and registrations AND be able to collaborate with the Clinical Affairs group, interact/negotiate with FDA and international regulatory agencies regarding product approvals. The successful candidate will represent Regulatory Affairs on project teams and establish strategies for obtaining product approvals. This position will be responsible for complaint handling procedures, maintaining regulatory records, manage/generate SOP's, comply with all safety policies and implement the Quality System as it applies to regulatory activities.

Click here for more information.

Sr. Clinical Scientist (Michigan)

Will be responsible for the implementation and execution of clinical trials under the supervision of the Director of Clinical. Responsibilities include: Working with the Director and Senior Director to design, prepare and implement clinical protocols and amendments; direct the protocol specific activities of outside contractors, and report protocol results. Candidates will participate on development teams and will interact with internal and external experts during individual, investigator and expert meetings. The candidate will also plan investigator meetings, identify, evaluate, and recruit clinical investigators, and supervise ongoing CRO relationships and performance. Candidate will resolve patient/subject eligibility and protocol deviation issues, monitor subject safety and participate in addressing issues from regulatory agencies.

Click here for more information.

BIOSTATISTICIAN (Missouri-Kansas City)

The ideal candidate will come from a Pharmaceutical company or a company that is involved in Clinical Trials. RESPONSIBILITIES:
1. Participates as lead biostatistician on single or multi-protocol projects and/or team biostatistician on large, complex, multi-protocol projects (such as NDAs or BLAs).
2. In lead biostatistician role (on projects with two or more biostatisticians), provide general direction of work of other biostatisticians to ensure efficiencies and to ensure consistency across studies (or across NDA components, as appropriate)
3. Interprets analyses and writes statistical and/or joint clinical and statistical study reports, as well as ISE, ISS, and Section 10 components of NDAs.

Click here for more information.

SR BIO-STATISTICAL PROGRAMMER (California)

Work with Biostatisticians, Statistical Programmers, and other RDQC staff members, and may work with Pharmacokineticists, Clinical Data Programmers, Regulatory and Technical Services, and other staff members in the accurate development and delivery of products. This includes providing SAS programming support and other technical assistance in the accurate development and delivery of all internal and external deliverables, as well as those intermediate steps required. QUALIFICATIONS: Education - B.S. in mathematics, statistics, computer science, or other analytical field including functional knowledge of SAS programming, or equivalent.

Click here for more information.

BIO-STATISTICAL PROGRAMMER (California)

Looking for a skilled SAS programmer with experience in the Clinical Drug development process. A Statistical background is required, along with knowledgeof SAS/SQL, SAS MACRO language and advanced knowledge of Base SAS.
Excellent organizational, interperpersonal, communication and technical database skills are essential. Client offers excellent benefits, which include medical, vacation, bonus and a stock purchase plan. There is a opening for two canidates immediately. Please note that the candidate must have direct Pharmaceutical experience.

Click here for more information.

BEHAVIORAL MEDICINE NURSE (California)

A 350 bed teaching Hospital is looking for a Behavioral Medicine Nurse immediately. The facility is looking for a nurse that has at least 2 years of experience as a Psych Nurse. There is both lockdown and non lockdown area's. There are excellent benefits which include medical, dental ,life insurance, 401k , disability and many more. The facility is located near downtown LA. Being a teaching hospital the newest and latest techniques and equipment are used.This is a Charge Nurse position for the night shift. 50K-70K

Click here for more information.

Coaching Lesson: "5 Mistakes That Can Kill Your Job Search"

In today's competitive job market, it is imperative that a job search candidate be FLEXIBLE, COMPELLING, and VALUABLE. If you consider that an estimated 20 million resumes fly through cyberspace and the traditional mail system daily, how are you distinguishing yourself from the pack? Job seekers who rely solely on traditional job search methods tend to stay unemployed longer than job seekers using more creative and riskier job search methodologies.

There are many ways job seekers sabotage their search efforts. As humans and creatures of habit, we tend to get in our comfort zone and stay there. The biggest mistake for all of us is to keep doing the same thing we've been doing - even when we keep getting the same results - NONE!

If you are not getting the kinds of interviews and job offers you feel you should be getting, perhaps one of these common mistakes is the culprit.

Click here for Cindy's complete article.

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