20 May 2011                    Published weekly by Biotech Ink, LLCVol 4 No 11

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Inside the Insider

Open Jobs and Contract Opportunities
 
Director, Medical Writing; San Francisco Bay Area
 
Principal
Medical Writer; Cambridge, MA
Medical Writer; Denver, CO

Medical Writer Project Lead; Denver, CO

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Jobs and Contract Opportunities
 
Susan E Caldwell, PhDThe 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. 

The Insider lists job and contract opportunities 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.

Director, Medical Writing

San Francisco Bay Area

Client has an exciting pipeline and is filing an NDA. Exciting times!!

Summary


Manages development of, writes, and edits documents to support drug development. Such documents may include study protocols, informed consents, investigator brochures, clinical study reports, INDs/NDAs, study manuals, and posters/slide decks/manuscripts.
 

Essential Duties and Responsibilities
 

Oversees the writing, editing and formatting of various documents to support clinical development.


Manages compilation of the components of complex submissions.


Edits, rewrites, or otherwise prepares drafts of documents.


Integrates various sources of information into a uniform style and language for regulatory compliance.


Manages medical writing staff-both internal and contract writers/editors


Communicates with external vendors as needed.


Determines methods and procedures on new assignment


Experience


Typically requires a minimum of 15 years of related post-graduate experience and/or combination of experience and education/training:
 

BS/BA degree in related discipline and 11 years of related experience; or, MS/MA degree in related discipline and 9 years of related experience,

Or a PhD degree in related discipline and 6 years of related experience.


Experience and significant participation in the preparation of clinical documents for regulatory
submissions (eg, clinical protocols, IBs, INDs, NDAs, BLAs) within a biotechnology, pharmaceutical, or CRO environment is required.

Experience with electronic publishing (eCTD) is preferred


Experience working in large cross-functional teams within a matrixed environment is required.


Management experience required. Experience managing a medical writing group is preferred.


Certification (eg, AMWA, BELS) is beneficial.


Knowledge/Skills and Abilities


Excellent writing ability and strong editorial & formatting skills are required.


Proficient using Microsoft Office suite on a Windows platform.


Ability to incorporate diverse feedback into a high quality document.


Ability to lead and supervise the work of others, and to provide direction to subordinates, peers, or teams based on general policies and management guidance.


Good/general knowledge of the AMA Manual of Style, ICH guidelines, Regulatory Affairs, and Clinical Development.


Strong analytical and business communication skills.


Skilled using electronic literature tools to obtain reprints of abstracts and medical publications.


Familiarity with oncology drug development is a PLUS.


Contact

 

Bonnie Gothmann/Vice President, Executive Search

415-684-1960

bonnie@corpsearchjmi.com

Principal Medical Writer

Cambridge, MA


Position is with Biogen Idec.

 

Job Description

 

Prepares clinical regulatory documents (protocols, CSRs, IBs, clinical summary documents); coordinates preparation of clinical documents for regulatory submissions for one or more programs. Represents Medical Writing department on project teams; leads document-related meetings. Reviews statistical analysis plans and clinical data reports to ensure consistent data reporting within a program and/or therapeutic area. Mentors junior writers on departmental processes related to document preparation; reviews documents written by junior writers for content and format; coordinates work of multiple writers contributing to a regulatory submission. Participates on departmental and interdepartmental initiatives. Able to analyze data. Has strong communication, organizational, and meeting skills.

 

Qualifications

 

7+ yrs regulatory writing experience with Master's; 6+ yrs regulatory writing experience with PhD.

 

Education

 

Degree in life or health science discipline. Master's required; PhD preferred.

 

Additional Notes

 

This position is an in-house medical writer position that sits in Cambridge, Ma (specifically Kendall Sq). It has the ability to telecommute up to 40%, but that is the maximum. Relocation benefits are available for out of state candidates.
 

Contact


If you're interested please send your resume and questions to Matt Soloperto at matt.soloperto@biogenidec.com.
 

Medical Writer

Denver, CO

 

Our client, a Medical Communications Company, seeks a Medical Writer to gather, interpret, and synthesize technical information on biomedical topics for presentation in various educational formats.  Position is located in the Denver, Colorado area.

 

Responsiblities

 

Provide accurate, high-quality medical writing


Broaden base of scientific and medical understanding


Communicate effectively, coordinating with colleagues


Provide drafts on time and on budget


Perform scientific reviews as assigned collaborating with Lead Medical Writer

 

Qualifications
 

Technical writing ability


Educational writing ability


Ability to acquire new knowledge based on solid grasp of science principles


Able to communicate effectively with graphic artists/animators


Literature search skills


Strong interpersonal skills to communicate with clients and colleagues


Time and Budget Management experience


Familiarity with software for word processing, spreadsheets, slide production, communication, scheduling, etc.


Knowledge of scientific disciplines (e.g. neurology, cancer, cell biology) including substantial educational background (BS/MS/PhD plus lab experience).  -Experience in writing  reports, summaries, and presentations of scientific information

 

Contact
 

Interested candidates should forward a resume and covering letter to:

Joan Blitman, VP, Jack Farrell & Associates:  joan@jackfarrell.com.

Medical Writer Project Lead

Denver, CO

   

Our client, a Medical Communications Company, seeks a Project Lead to manage timelines and resources (including budgets, staff, and other resources) to assure that projects are finished on time, on budget and with innovative content.  The successful candidate will develop and foster professional relationships with clients, vendors, Subject Matter Experts (SMEs), Key Opinion Leaders (KOLs), and colleagues.  Position is located in the Denver, Colorado area.

 

Responsibilities

 

Manage scope, accuracy, and integrity of scientific content


Manage client communication on assigned projects


Manage project budgets and timelines


Contribute to the development of new business opportunities and to the creation of project proposals

 

Qualifications


Scheduling skills


Project accounting skills


Content Management skills


Strong interpersonal skills to communicate with clients and colleagues


Time and Budget Management experience


Familiar with software for word processing, spreadsheets, slide production, communication, scheduling, etc.


Knowledge of scientific disciplines (e.g. neurology, cancer, cell biology) including substantial educational background (BS/MS/PhD plus lab experience) 


Client services support skills

 

Contact
 

Interested candidates should forward a resume and covering letter to:

Joan Blitman, VP, Jack Farrell & Associates:  joan@jackfarrell.com.

 

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Comments or questions? Email Susan at caldwell@biotechink.com.