|
|
| 4 June 2010 Published weekly by Biotech Ink, LLC | Vol 3 No 17 |
|
|
|
|
|
|
 |
|
|
| Of Pirates, Ghosts, and The Fool: Stumbling Toward a Unified Theory of Medical Writing
by Art Gertel (excerpt) |
An excerpt of Art Gertel's address, "Of Pirates, Ghosts, and The Fool: Stumbling Toward a Unified Theory of Medical Writing," is presented here that provides valuable insights into the practice and profession of medical writing. The speech accompanied Art's receipt of the Harold Swanberg Distinguished Service Award, given on 23 October 2009, at AMWA's 2009 Annual Conference in Dallas.
In his book, "How Soccer Explains the World: An Unlikely Theory of Globalization," Franklin Foer delves into soccer as a model for human conflict and cooperation around the globe. It is the spirit of cooperation that is so essential to success in the medical writing profession. I have played soccer all my life. It teaches many useful skills. Soccer is a sport that requires constant interdependence on one's teammates. You need to work as a unit, back each other up, and look for opportunities to distribut the ball (and potential glory) to your fellow players. Teamwork is an important characteristic of successful medical writing. You learn selflessness, you learn dedication, you learn commitment. You work with your teammates and very often distribute the glory (authorship?) to the center forward (principal investigator?). Sometimes one is required to make the great "save." In soccer, you aren't necessarily the star, but you can contribute; that's the way medical writing is-you are not usually the person who gets the credit, yet you are instrumental in providing the skills, knowledge, and wherewithal to succeed. So you are distributing those opportunities to your fellow teammates in order to have a successful outcome. That's a very important characteristic. We have had a lot of debate recently about authorship and what qualifies one to be an author and what qualifies one for acknowledgment. Acknowledge your teammates, even if they were not the goal-scorer. It is teamwork with rules that leaves room for individual creativity, and the result is that the whole is greater than the sum of its parts.
About the Author
|
|
Open Jobs and Gigs for Medical Writers |
 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.
Because of the tough job market, the Insider now lists open jobs 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. |
|
Senior Manager Medical Writer Gaithersburg, MD |
Note: In last week's newsletter, this position was erroneously presented as a contract job. Our apologies for the error; this is a permanent (staff) position.--S Caldwell
MAIN PURPOSE OF ROLE: To lead the medical writing function for our client's clinical development. A strategic and proactive role with responsibility for ensuring the function is professionally led and represented both within and external to the company, providing support and expertise to members of the clinical team. This role includes providing and overseeing medical writing aspects of several outsourced clinical research programs securing quality and best value at all times.
Key Responsibilities:
Author clinical submission documents and manuscripts, including: clinical study reports (CSRs); clinical study protocols; informed consent forms; investigational brochures; statistical analysis plans; safety monitoring committee/data safety monitoring committee charters; summary documents (including integrated summary of safety [ISS], integrated summary of efficacy [ISE], clinical overview, clinical summary CTD sections); risk management plans; summary of product characteristics and US package circulars; clinical sections of integrated product reviews; clinical development plans; manuscripts and abstracts for publication; clinical sections of grant and contract proposals to NGO and government partners; regulatory meeting briefing packages; IND and EU Annual Safety Updates; responses to agency questions; and other documents that may be assigned.
Detailed Responsibilities:Ensure critical review and interpretation of clinical efficacy and safety data for appropriate medically relevant and Standard Operating Procedure (SOP)/Good Clinical Practice (GCP)/International Conference on Harmonisation (ICH) compliant presentation Manage review and approval process of clinical submissions documents, which includes authoring documents in a team environment, generating consensus among reviewers, and facilitating discussions in an efficient manner Provide process, content, and submission/document planning expertise; advise team on resource utilization, efficiencies, timelines and interdependencies Oversee preparation of clinical submission documents for a program; review and provide feedback on clinical submission documents to maintain consistent content, messaging and style Reviewing protocols, statistical analysis plans and tables figures and listings Prepare abstracts and articles Ensure adherence to established regulatory, company SOP, and house styles, general quality, and ICH/GCP guidelines Write, review, and update company SOPs and related templates (eg CSR, protocol, narratives, IB) Prepare and represent Medical Writing for internal (QA) and external audits (MHRA, FDA) Participate in and/or lead the development of processes and tools related to authoring and reviewing of clinical documents; continually share best practices in an effort to create higher quality documents more efficiently Summarise clinical trial data and analyse and interpret clinical data, discussing results with internal teams and KOLs Liaise with vendors/external contractors as assigned; ensure timelines and quality of product when the writing of a document is outsourced Mentor, coach, and/or otherwise assist in the training and development of other medical writers Contact:
Susan L Valdes
Principal Staffing Consultant
BioTech Resources LLC
|
|
Project Manager, Document Management/Regulatory Submissions Dallas/Ft Worth, TX |
Client Background:
My client is the world's leading eye care company with sales of $6.3 billion. The company's more than 15,000 employees worldwide, work in 75 facilities around the world to research, develop, manufacture and sell products in more than 180 countries. My client provides an extremely generous benefits package which includes a 401(k) Plan which matches employee contributions up to 5% of eligible pay at the rate of $1.00 for each dollar contributed, and a Retirement Plan (ARP) in which the company contributes 7% of eligible pay to the accounts of all eligible employees. By combining the company's contributions to the 401(k) and ARP, employees can receive up to 12% of eligible pay from the company toward retirement. The company also offers medical, dental, vision, life and disability coverage, an on-site fitness center, and much more. Qualifications:
Experienced project manager with experience in document management and publishing, especially a pharma background working with regulatory submissions. Skills and experience with electronic submissions, including submission planning and document analysis; regulatory affairs systems, and document management software. Project Management Experience Experience with eCTD Familiarity with Insight Publisher a plus Bachelor's degree is strongly preferred PMP certification strongly preferred
Position Duties: This is an Information Technology role within a Research and Development department and will involve supporting three to four publishers. Initially this person will be supporting software, such as Insight Publisher, but will later architect and define the support model which will be used globally. There will be a great deal of coordinating upgrades, new releases, patches, etc. with the software vendors and rolling those out within the R&D department. This person will report to the Manager of R&D Lifecycle Systems. My client will provide funds for relocation to the Dallas/Ft Worth area. Contact:Steve Brown The Brown Group, LLC 6325 Mercedes Ave Dallas, TX 75214 Tel: 214-213-4842 Email: steveb@browngroupllc.com
|
|
|
|
|
|
|
|
|
