30 July 2010                 Published weekly by Biotech Ink, LLCVol 3 No 21

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Open Jobs and Gigs for Medical Writers
 
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. 
 
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 [email protected]. We'd be delighted to publish such positions in the next issue of the Insider.
Regulatory Medical Writer
California Area
 
Type of Position:
 
Contract/contract-to-perm
 
Responsibilities:
 
Writing of documents for submission to global regulatory agencies including clinical study reports (CSRs), clinical protocols, clinical safety and efficacy summaries (ISSs/ISEs), investigator's brochures (IBs) and manuscripts/posters as necessary
 
Cross functional interaction with Medical Director, Biostatistics, Drug Safety, Regulatory Affairs and Clinical Operations for key regulatory documents
 
Distribute drafts, incorporate comments and manage the approval and archiving of final documentation
 
Create project plans and lead the team responsible for the on-time completion of documents written according to regulatory requirements
 
Requirements:
 
Bachelors degree in Science, advanced degree preferred
 
3+ yrs experience writing regulatory documents for a pharmaceutical or biotechnology company
 
Oncology experience preferred, a HUGE plus
 
Hands-on experience of current global regulatory requirements including e-submission requirements of clinical regulatory documents
 
Contact:
 
Please apply online or email Lindsey Summers at [email protected].
Module 3 CMC Writer
California Area
 
Type of Position:
 
Contract, on-site position
 
Responsibilities:

Module 3 section writing of CMC submissions

Requirements:
 
Prior experience as a technical writer

Prior experience drafting CMC module 3 sections

Have sat in either a regulatory or an R&D department writing these documents
 
Contact:
 
Please apply online or email Lindsey Summers at [email protected]
Manager, Medical Writing
New Jersey Area
 
Type of Position:
 
Permanent, on-site position

Responsibilities:
 
Facilitates performance goals for filing regulatory submissions by coordinating all activities involved in planning and preparing regulatory documentation

Coordinates documentation activities of all contributors to dossier

Implements and manages documentation processes

Manages external dossier documentation support

Coordinates all documentation-related training

Ensures effective documentation-related planning and development and integration of key regulatory messages

Manages the document review process

Drives key documentation activities

Ensures appropriate consistency between regulatory documents and marketing publications

Requirements:

Advanced degree, preferably in natural sciences, extensive relevant experience in the pharmaceutical industry REQUIRED

5+ years experience in drug development in a global company

Experience with preparation and submission of regulatory dossiers in US and Europe , preferably having participated in the preparation of high-level summary documents in at least two different submissions

Demonstrated ability to lead and communicate effectively at all levels in a complex multi-functional environment
 
Contact:
 
Please apply online or email Lindsey Summers at [email protected]
Medical Writer
New Jersey Area
 
Type of Position:
 
Permanent, on-site position
 
Responsibilities: 
 
Produces clinical documents (e.g., study reports, CTD clinical summaries and Investigator Brochures) with supervision, as necessary.

Provides input into the production of Data Reporting and Analysis Manuals.

Resolves issues, errors, or inconsistencies in report/summary data with pertinent members of the team.

Plans and creates timelines for the production of assigned clinical documents.

Acquires knowledge of regulatory guidelines, procedures and best practices and applies these to assigned clinical documents.

Provides feedback on existing guidelines.

Reviews clinical documents with supervision as necessary.

Reviews documents for organization, clarity, scientific standards and consistency between textual presentations and tabular or graphical displays.

Serves as a member of Study Management Teams, Clinical Teams, and RAFTs with supervision, if necessary.

With increasing experience, takes on mentoring of less experienced group members in specified areas.

Requirements:

Ph.D. in a relevant scientific discipline or MS with documentation experience (or equivalent).

Demonstrated clear, high-quality writing style in the English language.

Ability to independently analyze and synthesize data from abroad range of scientific disciplines
 
Contact:
 
Please apply online or email Lindsey Summers at [email protected]
Medical Writer (Drug Safety)
California Area
 
Type of Position:
 
6-month, on-site contract
 
Responsibilities:
 
Actively coordinate and participate in the production of periodic and ad hoc DS medical and regulatory reports including, but not limited to, safety sections of Clinical Study

Reports and health authority submissions, periodic safety update reports, and issue work-ups.

This includes writing, editing, and coordinating production of adverse event narratives and safety-related documents.

Create and maintain departmental and safety-related document templates and controlled documents as needed.

Proactively review and understand molecules and protocols (where applicable) that are associated with specific writing projects to facilitate efficient and effective handling of data and document structure

Effectively communicate new developments within the regulatory writing field to internal and external groups (e.g., Regulatory, Clinical Science, etc.) to ensure overall alignment with industry standards

Participate in committees, departmental initiatives, clinical team filing activities, and special projects in collaboration with DS management

Effectively interact on multiple projects working independently as well as within intra- and inter-department functional teams

Maintain effective communication with and influence all levels throughout a highly matrixed organization, and builds successful working relationships across disciplines

Requirements:

Excellent verbal and written communication skills, organizational skills, and time and resource management skills.

Able to partner effectively with internal and external partners in a proactive, positive and constructive manner

Able to manage multiple projects and timelines, and accommodate multiple priorities in a fast paced and changing environment.

Organized and detail oriented, demonstrates a high level of commitment and drive for excellence, and generates enthusiasm

Strong collaboration, communication and leadership skills to effectively and clearly coordinate across multiple functional areas with a diverse group of team members

Bachelor's degree in Science or Business-related field; clinical education and experience preferred.

Minimum 5 years of medical writing or equivalent experience.

Highly skilled in Microsoft Office applications, Adobe Acrobat, PowerPoint, and other relevant applications for writing, editing, development of controlled documents, etc.

Knowledge of biotechnology/pharmaceutical industry, the clinical drug development process, and drug safety preferred.

Knowledge of regulatory requirements and ICH Guidelines as related to regulatory writing.
 
Contact:
 
Please apply online or email Lindsey Summers at [email protected]
Biorepository Scientist
Pleasanton, CA
 
Duration:
 
6 months+ contract 
 
Job Description:
 
The candidate will provide careful management of the planning, procurement, inventory
and distribution of biohazardous samples.
 
This position performs activities in support of daily operation (inventory tracking, processing, distribution, storage, withdrawal, and destruction of biological samples).
 
The position holder will be responsible for reconciliation of physical inventory of biological material with virtual inventory and collection documentation. This position
requires work with clinical specimens at lower temperatures in a laboratory setting.
 
Specific duties will include sorting the human specimen inventory to match the database and specimen collection records, receiving biological material shipments, verification, accessioning, processing, distribution and storage of such material from clinical trial and other sources, as directed.  
 
Duties: 
 
Maintains accurate inventory of samples in the Biospecimen repository.
 
Maintains inventory of specimen and associated information in the sample
management system.
 
Participates in routine lab maintenance, lab safety, ISO and QSR implementation and supports compliance with the policies and procedures for an efficient
Biorepository operation.
 
Performs sample processing, registration, shipment and verification activities.
 
Maintains accurate records and properties associated to samples using a variety of
data base systems.
 
Records and thoroughly documents discrepancies. Communicates as needed with the appropriate entities to resolve discrepancies. Documents the resolution of discrepancies. 
 
Requirements:
 
BS Degree in Biological Science or related field, or equivalent combination of education
and work experience
 
5 years of relevant experience
 
Proven experience with handling and processing of biological material in a laboratory
environment
 
Demonstrated communication and interpersonal skills
 
Ability to work within a team environment to achieve desired objectives
 
Logical, objective-driven approach
 
Self-reliant and self-motivated
 
Familiarity with the major MS Office applications such as Word, Excel, Access
 
Contact:
 
Please email word document of your resume' to SUDHA PARAM at [email protected]
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Biotech Ink Insider medical writing newsletter information web site 
 
Biotech Ink Insider medical writing newsletter archives
 
 
Susan Caldwell's Medical Writing Twibe (a special-interest Twitter group; Twitter account required)
 
Comments or questions? Email Susan at [email protected].