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| 29 January 2010 Published weekly by Biotech Ink, LLC |
Vol 3 No 3 | |
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| Greetings! |
 This week, one of my medical writer colleagues asked me what I do about overlapping medical writing projects. That is, if one project is winding down and another client's project is ramping up, what happens when the older project gets extended? All of a sudden, life is no longer simple, and handling this timing conflict between old and new projects can be tricky. Tricky for the writer to get the work done. Tricky for the writer to manage the clients' expectations while working through the overlapping work load.
How do you deal with this problem? If you haven't lived through it yourself, how would you handle it if it happened to you?
On my blog, Biotech Ink Spots, I've posted this question and asked for readers' comments. If you have something to contribute to the discussion, do chime in!
After I receive some useful responses, I'll include an article in this newsletter that summarizes and excerpts your ideas. We can all benefit from the diverse viewpoints within the medical writing community, so please let me know what you think!
On a related note, if you think of interesting questions or topics that relate to medical writing as a career, or medical writing technical questions, please send them to me at caldwell@biotechink.com. I'll post them on my blog for readers to answer, and we'll see their ideas here in the newsletter, too.
Warm regards,
Susan
Susan E Caldwell, PhD
Medical Writer Consultant and President
Biotech Ink, LLC
Tel: 650-286-9300
Fax: 650-286-9301
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Open Jobs and Gigs for Medical Writers |
The jobs listed in the Biotech Ink Insider come to us mostly by word-of-mouth and direct contact with hiring managers and recruiters. If no new jobs are communicated to us in a given week, the Insider won't be published that week. See also our disclaimer at the bottom of the newsletter.
Because of the tough job market in recent months, we are now publishing jobs that are closely related to medical writing, or that have a strong writing role, regardless of their titles.
If you're a writer or editor and are getting calls about staff or contract positions 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. |
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Director/Senior Director, Medical Writing Massachusetts |
The Director/Senior Director will be responsible for managing and coordinating all medical writing activities Research and Development including protocols, clinical study reports, investigator brochures, IND and NDA annual reports, and any other document involved in a regulatory submission. The Director/Senior Director will be responsible for line management of all staff within the Medical Writing function.
Functions:
- Oversee generation of the clinical portion of all IND filings
- Oversee production of Integrated Clinical Study Reports, Integrated summaries of Safety and Efficacy, Annual IND reports, IND safety reports to support NDAs
- Maintain and develop protocol and clinical reporting templates and any other SOPs associated with the medical writing function.
- Oversee Investigator Brochure templates and ensure Investigator brochures are produced in accordance with regulatory and corporate policies.
- Manage consistency of style format and content for all documents required for international regulatory submissions.
- Serve as primary liaison between all departments in Research and Development for the production of regulatory documents.
- Mentor and manage all medical writing staff.
- Develop functional structure and job descriptions to allow growth and development opportunities for Medical writing staff Ensure that all documents produced by the Medical Writing Department have undergone appropriate Quality control and consistency checks to meet internal standards
Qualifications:
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Experience required: BS w/ 5 or more Years experience, at least 2 years management experience
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Knowledge & skills
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The position requires an individual with excellent organizational skills
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The individual must:
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Be highly self-motivated.
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Be a strong team player and provide a vision to develop the medical writing group.
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Demonstrate the ability to manage, mentor and train individuals.
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Possess a fundamental working knowledge of ICH, FDA and EMEA GCPs
Contact:
Robert Posluszny (Bob Poz)
Managing DirectorJudge, Inc. Pharmaceutical Division
Phone: 732-346-9100 x 4212
Toll free: 888-228-7165 x 4212
Fax: 732-497-4213
RLP@JUDGE.COM
www.judgeinc.com |
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Senior Scientific Medical Writer, Contract Montville, NJ |
Length of Assignment: 6 mos - 1 year, contract to perm
Start Date: As soon as possible
Location: Montville NJ, on site
Client:
Our client is a multi-billion dollar company and a worldwide leader in the field of pharmaceutical and medical products. They are a research-based company who's purpose is to bring diagnostic and therapeutic innovations to the healthcare community with a commitment to advance patient care and to shape the future of medicine. Their focus lies in the areas of Women's Healthcare, Oncology, Diagnostic Imaging, and Neurology markets.
Position:
The Senior Scientific Writer is the medical writing expert responsible for the research, writing and editing of regulatory documents. This person will provide full lifecycle support from clinical study protocols through regulatory dossier preparation and submission.
Participate in the development of the strategy of the submission and the label and carry those key messages into regulatory documents
Assure quality and timely preparation of clinical documents across all therapeutic areas, including clinical study reports, clinical study protocols, investigator's brochures, and clinical summaries and overviews
Required Skills:
- BS or equivalent with 6 years experience in a scientific discipline and a minimum of 6 years in medical writing, OR
- MS, PhD, or equivalent with a minimum of 5 years of previous industry experience and 3 years of medical writing experience
AND
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Excellent written and oral communication (English)
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Demonstrated working knowledge of scientific principles
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Familiarity with all phases of medical research and ability to learn new medical concepts quickly
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Familiarity with statistics and experimental design
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Ability to summarize complex data and identify relationships
Contact:
Jessica Leveille
Manager, Biomedical Delivery Services at Orbis Clinical
Direct Line: (781) 496-3133
Direct Fax: (866) 855-5872
Email: JLeveille@orbisclinical.com
100 Unicorn Park Drive
Woburn, MA 01801 |
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Technical Writer, Contract San Jose, CA |
Full-time, contract position for 3-5 months, developing user documentation for lab analyzer equipment.
Location: Onsite required in San Jose, CA. CANDIDATES MUST BE LOCAL.
Requirements:
- Expert FrameMaker skills.
- 3+ years experience writing about lab analyzers or some other biotech equipment
- 7+ years of Technical Writing experience
- Able to work independently
- Familiarity with style guides
- Work closely with cross-functional teams
- Communicate status, issues, and risks to project stakeholders
- Ability to meet deliverables
Rate: $48.50 on 1099
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Senior Manager/Associate Director, Medical Writing Cambridge, MA |
Relocation is available for the right candidate.
Responsibilities:
Responsibilities will include the building and management of a medical writing editing, and publishing group. Major focus will be the management of operations involving production of clinical documents, regulatory documents, presentation materials, and publications. Will work closely with biology, medical affairs, regulatory affairs, and the commercial group. Also will be responsible for the development of processes, formats and guidelines for clinical documentation. Will manage other medical writers and medical personnel. May write, review and/or edit documents ensuring the integration of scientific, medical and regulatory input. Ensures compliance with current regulations and requirements. May oversee and/or evaluate external consultant writers. Ensures effective planning and management of timelines for all aspects of technical documents. Selects, develops and evaluates personnel to ensure the efficient operation of the function.
Additional responsibilities for this individual will include coordination of medical writing activities across departments such as coordination of required reviews and reviewers, incorporation of reviewer comments, finalization of documents, including proofing, editing, reviewing, and revising as necessary.
Technical Skills:
- Ability to recruit and manage contract medical writers and/or internal medical writing team
- Outstanding writing skills coupled with a comprehensive knowledge of the drug development process and regulatory guidelines are key, along with careful attention to detail
- Excellent interpersonal and communication skills are essential
- Facility with various computer software applications and formats
- Experience in oncology preferred
This individual will build and manage a team of contract medical writers and independently contribute by writing, reviewing, revising and formatting clinical and other regulatory documents and publications, such as clinical protocols, clinical study reports, investigator brochures, annual updates to regulatory submissions, other regulatory submissions, abstracts, manuscripts, reviews, posters, and slide decks for internal and external use. In addition, the individual will perform quality control review of clinical and regulatory and publication documents. The individual will represent Medical Writing on project teams, and as such advise the teams on content and format requirements for various documents as well as coordinate writing activities for clinical development programs (eg, timelines and review/revision responsibilities) with the project teams. Collaboration with the biology group, program management team, the regulatory group, and the commercial/marketing group will be essential.
The individual will remain informed of the latest professional, technological, and regulatory developments in medical writing as well as maintain knowledge of product areas, current trends, and current literature.
Requirements:
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A minimum of BA or BS degree. Advanced scientific degree in the life sciences preferred (MS or PhD)
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Four years or more of direct biotechnology or pharmaceutical industry experience as a Medical Writer
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Experience managing and preferably building a medical writing team
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Excellent ability to interpret and present scientific and clinical trial data and understand statistical analyses
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Ability to work well both independently, as well as on a team, with strong interpersonal skills
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Initiative and the ability to handle a variety of projects simultaneously and productively with minimal supervision
Contact:
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