Advanced Clinical Announces Bernice Welles as a Core Member of its Strategic Advisory Ecosystem

Advanced Clinical, a leading provider of clinical research services, announces Bernice Welles as a core member of its strategic advisory ecosystem.

Bannockburn, Ill. (Vocus) September 30, 2010

Advanced Clinical, a leading provider of clinical research services, announces Bernice Welles as a core member of its strategic advisory ecosystem.

As a strategic advisor, Bernice Welles has contributed to Advanced Clinical’s Industry Leading R&D Performance (ILRDP) framework that seeks to make the “business of R&D” more effective and efficient for Life Sciences companies. Bernice has been a key driver in the development and regulatory approval of drugs, biologics, devices as well as combination therapies across multiple therapeutic areas. “Moving a drug and/or biologic from development to approval is, possibly, the hardest earned process in the Life Sciences industry,” says Bernice Welles, Advanced Clinical Strategic Advisor.

Welles’ accomplishments span several leadership roles in companies at different stages of growth. At Genentech, Welles was appointed to several management positions to drive the drug and biologics development portfolio across multiple therapeutic areas. Two of Welles positions included: Senior Director of the Specialty Therapeutics Unit and Vice President of Product Development. One important program that Welles progressed was the Lucentis injection for wet age-related macular degeneration (AMD). AMD is a disease of the eye that is the leading cause of blindness in older Americans and causes loss of the ability to see straight ahead and may make it more difficult to read, drive, or perform other daily activities. By moving forward this program, several thousand patients were able to be treated.

Welles held a Venture Partner position at MPM Capital LLP, where she participated in discussions on medical devices and helped assess device instruments. At MPM, Welles also took the lead on several investments and helped portfolio companies such as CoTherix maneuver the regulatory process leading to an early approval for Ventavis®, a new therapy for pulmonary hypertension.

Welles currently holds executive positions as CEO of Alquest Therapeutics Inc. and Vice President, Clinical and Regulatory, of Enject Inc., both innovative biotechnology startup companies.

With years of experience heading teams across functional areas, Welles credits integration as being one of the keys to her success. Using her capability to integrate the knowledge she has gained during her career, Welles is able to pull together all of the elements of clinical and regulatory as well as leverage the science behind development programs to create a significant, positive impact on the Life Sciences industry.

“I am proud to be working with Advanced Clinical,” said Bernice Welles. “Being part of this expert strategic advisory team allows me to continue to work with a topflight team to create new levels of R&D Productivity for companies in Life Sciences and bring much needed treatments to the market for those who need them.”

About Advanced Clinical: Advanced Clinical provides consulting services, strategic sourcing (CRO), talent management, and technology solutions to the Life Sciences industry. With 15+ years of experience, Advanced Clinical is an established presence in the clinical research field, providing services specifically for Pharmaceutical, Biopharmaceutical, Biotechnology and Medical Device organizations. Advanced utilizes a value-based, “One Team” approach. To learn more, visit http://www.advancedclinical.com/.

Contact:
Rosemarie Truman
rtruman@advancedclinical.com
1200 Lakeside Drive
Bannockburn, IL 60015
Ph: 202-438-2208

Advanced Clinical is Making a Difference in Talent Management

We are pleased to provide vital talent for companies and meaningful career opportunities for clinical research professionals.

We offer talent management services through contract staffing, direct hire placement, executive search, and payrolling (“asset transfer”). These different talent acquisition paths allow Advanced Clinical to effectively and efficiently connect talent to career opportunities within the clinical research industry. Our ability to provide and manage talent directly impacts their clients’ R&D success. For candidates, we offer a “career platform,” giving them not only employment, but also the chance to:

• Make a difference
• Become a star
• Provide insight
• Be part of an exceptional, topflight team
• Pursue their dreams
• Grow personally and professionally

Some of our consultants’ experiences are described below:

Tim, whom we placed as a Clinical Project Manager, said, “[Advanced Clinical is] very much focused on building relationships, finding out where my interests lie, and where my needs are.”

Buddy, whom we placed into Clinical Data Management, said, “I’ve been very pleased to work with Advanced Clinical because I feel that they are very well connected and understand the industry. Advanced Clinical has helped me not just find the next gig, but they have helped build my career.”

See live examples of our refreshing approach to talent management and career placement: http://www.youtube.com/user/advancedclinicaljobs#p/u/7/WCM-KdbGmE4

Advanced Clinical believes that creating positive experiences for candidates is cornerstone to building a vibrant, loyal workforce. Successful talent management positively impacts clinical research companies through lower overhead, more productive teams, and stronger retention of critically needed talent.

To learn more, visit http://www.advancedclinical.com

Writing the Future of Clinical Research

The past several years have seen the rapid growth of the Medical Writing field, with the market more than doubling from an estimated $345 million in 2003 to $694 million in 2008, according to a Centerwatch Monthly report. Membership in the American Medical Writers Association, which sets the profession’s standards, increased 14% in the same time to nearly 5,700 members globally. Additionally, two dozen colleges and universities have recently established either certificate or degree programs in medical or scientific communication. Across the industry, Medical Writers are being highly prized for their ability to communicate scientific data effectively and efficiently, as well as taking on additional roles, such as transnational trial coordination and quality assurance, in the drug development process.

What do Medical Writers do?
Medical Writers both have a thorough background in scientific areas and are adept at communicating this information to various audiences. They perform numerous important functions, including the following:
• Communicate scientific and clinical data to a range of audiences in a wide variety of formats
• Combine scientific knowledge and their research skills to present information for targeted audiences
• Write clinical trial protocols, clinical study reports, and other documents for submission to the FDA
• Prepare journal articles, conference posters/presentations, internet content, and training/marketing materials

Is Medical Writing for me?
Before you consider entering the Medical Writing field, know that there are several key attributes that make the field a fit for individuals:
• Interest in scientific fields and writing
• Excellent written and oral communication skills
• High-level detail orientation
• Good interpersonal skills and “team player” attitude
• Ability to multi-task, learn “on-the-job”, and meet project deadlines

Additionally, Medical Writers are expected to have a level of technical knowledge and skills such as:
• Current scientific writing and editing techniques
• Software and systems, such as document management software, Microsoft Office suite, as well as reference, literature, and publishing software
• Company policies, procedures, and tools
• Industry guidelines
• Scientific area background with statistical knowledge preferred

Who do Medical Writers work for?
• Pharmaceutical companies
• Medical communication agencies
• Contract Research Organizations (CRO)
• Freelance Publishers
• Academic Medical Centers, Medical Associations, Publishers, Magazines, Websites

What are the benefits?
• High involvement with the latest scientific research and information
• Rewarding work that makes a difference
• Can have flexible work hours
• Current high market demand for Medical Writers
• A number of opportunities for career development
• High entry level compensation (~$50-60,000) and employee benefits
• Flexibility to switch jobs

What jobs are available?
Advanced Clinical has a number of exciting Medical Writing opportunities available across a wide range of experience, including:

Senior Medical Writing Program Manager (Oncology) – Northern Suburbs of Chicago, Illinois
One of our clients is seeking a Senior Medical Writing Program Manager (Oncology) also known as Global Medical Writing Lead, generally for early- to mid-stage development global project teams and may act as a back-up/supporting GMWRL for several projects.

The individual will provide:
• Project leadership with respect to program documents and writing activities commensurate with experience
• Review of work and manage/coordinate writing activities across an entire program, and may review and amend the work plans developed by a Document Working Group Facilitator (DWGF; lead medical writer in a working group) for a particular document
• Intellectual leadership and contributes document knowledge and expertise to the project team

Associate Director, Medical Writing – Princeton, New Jersey
A client in the Princeton NJ area is looking to add a permanent Associate Director of Medical Writing to their team.

The individual’s responsibilities include:
• Deliver high quality regulatory documents in accordance with regulatory guidelines that meet ICH standards, project timelines, and specifications set forth for the projects
• Prepare clinical summary documents, including (but not limited to) Integrated Summaries of Safety and Efficacy for NDAs, MAAs, and/or NDA Supplements/Type II variations in eCTD format
• Coordinate and prepare Meeting Content Packages, and responses to regulatory authorities as well as the management and preparation of a variety of clinical documents including clinical study reports, narratives, investigator brochures for Phase I to IV clinical trials, and drug safety related documents such as Periodic Safety Update Reports

Senior Medical Writers/Writing Team Leaders – Worldwide
A client is seeking experienced medical writers to serve as Team Leaders at their office locations around the world.

Team Leaders are strategic consultants, project leaders, and hands-on writers who:
• Serve as subject-matter experts for clients, guiding and advising them on strategies and best practices for achieving approval from health authorities
• Serve as subject-matter experts for team writers, providing leadership, advice, and continual mentoring
• Actively participate in development and writing of documents
• Ensure quality, adherence to budgets and timelines, and compliance with SOPs, policies, and other guidance as required by the company, regulatory bodies, and individual clients

See www.advancedclinical.com