Biotech Ink Insider, Vol. 3 No. 22

Open Jobs and Gigs for Medical Writers

Reports to:

President and COO

Position Description:

The General Manger will be responsible for driving business in the company's Virology and Gastroenterology specialty areas and for the Clinical Care Options Virology and GI products and manage the Virology and GI Team including sales, marketing, program development and program management. This individual will partner with other key functional areas including: Production, Technology, Editorial, Operations, and Finance and the senior management team to develop, implement and manage strategic initiatives and day-to-day activities to support the success of the Virology and GI business and for achieving bottom line projections (profitability) and managing to annual budgets. There is a potential for this position to oversee the development of business in new specialty areas including cardiology, neurology and psychiatry.

Responsibilities:

Develop strategy for optimal product offerings within the Virology and GI specialty areas including Online (collaborating with Technology), print and live meetings.

Oversee and manage program managers and vendors in the execution of all live programs in the Virology and GI space including CCO HIV Annual Meeting, satellites, dinner meetings, etc.

Responsible for establishment of budget, bottom line profitability and their achievement for all Virology and GI deliverables

Manage Virology and GI advisors in partnership with Editorial

Manage Virology and GI sales activities, hire sales persons (Director of CME Program Development) and their activities to develop optimal positioning and achieve sales objectives and quotas

Identify, close and manage business development relationships and alliances and responsible for managing partnerships within specialty area

Responsible for organizing and planning activities, leading meetings, managing vendors, ensuring effective program design and completion

Develop the strategy and implementation of the brand images, market position and competitive advantage for Clinical Care Options HIV, Hepatitis and GI.

Develop and implement with the Marketing group the Virology and GI marketing plans and programs

Help create product communications platforms, messages and vehicles for Virology and GI customers

Partner with editorial, marketing and other departments to create compelling proposals

Thoroughly understand the competitive landscape and communicate key competitive information within the company

Responsible for developing strategy to successfully compete against other companies in the competitive landscape

Develop and manage external facing marketing functions including press releases and the coordination with Marketing of CCO's presence at Virology and GI conferences and represent CCO at major Virology and GI conferences

Responsible for the development and delivery of new CCO products in the Virology and GI area

Assist with other responsibilities in other specialty areas as needed

Position Qualifications and Requirements:

Travel

Significant travel to commercial supporters and medical conferences both in the US and internationally is required in order to accomplish the goals of this position

Location

Home-based office is acceptable; however, a location convenient to a major airport is important. Travel to the corporate office in Reston, VA a few times a year will be required.

Experience Desired

Three to five years in senior sales, account management and/or direct responsibility for grant procurement role in a medical education company, ideally in online medical education programs. In addition, 3-5 years of developing grants and securing funds for educational and/or promotional programs in the field of gastroenterology and/or virology including, but not necessarily exclusive to, commercial, governmental and medical societies.

Skills and Knowledge

An advanced degree in healthcare or business is preferred but not required. However, must have a working understanding of current research and treatment of GI and/or HIV

Strong knowledge of the Internet and computers, including a sophisticated knowledge of existing Internet-based educational program models

Working knowledge of the ACCME and other regulatory agencies' guidelines and policies in relation to commercially supported educational activities

Excellent presentation, communication (oral and written) and interpersonal skills

Skill in working effectively on multidisciplinary teams and in decentralized work and communication environments

Contact:

The hiring company has engaged Jack Farrell & Associates (www.jackfarrell.com) to find the winning candidate for this position. Interested candidates should provide a resume by email to joan@jackfarrell.com. Thank you.

Regeneron is a biopharmaceutical Company that discovers, develops, and commercializes therapeutic medicines for the treatment of serious medical conditions. Regeneron currently markets ARCALYST™ (rilonacept) Injection for subcutaneous use for the treatment of a rare, inherited, inflammatory condition. The company has therapeutic candidates in clinical trials for the potential treatment of cancer, eye diseases and inflammatory diseases, and has preclinical programs in other diseases and disorders.

With a strong research base and product focus, Regeneron is able to understand thoroughly the biology of specific disease states, discover potential therapeutic candidates and evaluate product candidates in clinical trials. Regeneron has developed several proprietary platform technologies, which it has incorporated into a comprehensive system that allows it to accelerate the discovery and design of fully human antibodies and move these candidates rapidly into clinical development.

Position Summary:

The Principal Medical Writer works independently writing CSRs, CSPs, IBs, and Clinical Summaries. Contributes to document strategy in a therapeutic area, and can lead the Medical Writing effort in a clinical filing. Ensures adherence to regulatory guidelines, and works with senior members of the department to help set department document standards. Helps to coordinate the efforts of the consultant writers and vendors.

Essential Duties and Responsibilities include, but are not limited to, the following:

As the Medical Writing Lead, will provide guidance to the Medical Writers and Study Team for the content, format and organization of clinical filings.

Working with the clinical team, writes the following documents: Clinical Study Protocols, Clinical Study Protocol Amendments, Clinical Study Reports, Investigator brochures, Clinical Summaries and other documents, as needed.

Review documents related to the CSR, such as SAP, draft TFLs, ensuring that they provide the data necessary for an appropriate CSR.

Responsible for tracking all documents in a therapeutic area.

Ensure adherence to regulatory guidelines and works with senior members of the Medical Writing staff to help produce department guidelines, templates, standard timelines and SOP's.

Liaise with Study Director and/or Medical Monitors to shape and review content of the documents.

Resolve issues and escalates problems, as necessary.

Requirements:

At minimum, a Bachelor's degree (BS) from an accredited college or university, and 6 years of medical writing experience (CSR's, CSP's, IB, and Clinical Summaries).

Experience leading NDA/BLA filings and some management experience.

EMEA filing experience a plus.

Strong knowledge of the clinical research process and regulations/guidelines required.

Must have strong organizational, interpersonal, leadership, and communication skills.

Must be able to communicate effectively in large or small group settings.

Effective influence and relationship management skills required.

Working knowledge of one or more EDM systems.

Contact:

We offer an extremely competitive compensation and benefits package to all our employees, including stock incentives, 401k with company match as well as the expected health and welfare benefits. Comprehensive relocation benefits are available, as required.

To apply, please submit your profile and resume at www.regeneron.job - Job Req #1737, for immediate review and consideration.

The Medical Writer/Sr. Medical Writer will write standard Medical Writing documents. Tracks writing projects and adheres to regulatory guidelines and department document standards.

Essential Duties and Responsibilities include, but are not limited to, the following:

Works with the clinical team and/or other Medical Writers, to write or help to write the following documents: Clinical Study Protocols, Clinical Study, Protocol Amendments, Clinical Study Reports, Investigator brochure and Other documents, as needed.

Tracks writing projects, and ensures adherence to regulatory guidelines and department document standards.

Ensures maintenance of document standardization through use of model documents/templates and appropriate peer review.

Liaises with study director and/or medical monitors to shape and review content of documents. Follows up with other functional groups for materials needed for document completion.

Resolves issues and escalates problems, as necessary.

Requirements:

Basic knowledge of the clinical research process and regulations/guidelines required. Scientific and technical reading, writing and editing skills required. Strong organizational, interpersonal and communication skills. Must be able to develop and present varied and unique ideas. Effective influence and relationship management skills required.

Bachelor's degree (BS) from an accredited college or university plus minimum 3 years of medical writing experience.

Contact: