19 February 2010                 Published weekly by Biotech Ink, LLC Vol 3 No 5

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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 [email protected]. We'd be delighted to publish such positions in the next issue of the Insider.
Manager, Medical Writing
Nutley, NJ
 
Permanent, on-site position
 
Responsibilities:  
  • Facilitate 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].
 
PharmAscent, A Division of The Ascent Services Group specializes in nationwide direct hire and contract placement for the Pharmaceutical and Biotechnology industry.
Director, Global Medical Writing and Scientific Communications
Location Not Specified
 
i3 Statprobe focuses exclusively on providing the pharmaceutical and biotechnology industries with comprehensive, integrated data service solutions that include data capture, summary, analysis, and reporting for clinical trials across all phases of research. The company demonstrates leadership and innovation by leveraging world-class process design and six-sigma quality, affording clients the ability to maximize efficiencies and exceed customer expectations.
 
As a UnitedHealth Group company, i3 Statprobe is part of a worldwide health care service organization that uses innovation, integrity and commitment to prepare for the future - and you can prepare for yours with us. It's a rare combination for success that only a career with i3 Statprobe can provide.            
 
We are currently seeking a Director, Global Medical Writing and Scientific Communications, to be based in Ann Arbor, MI; Cary, NC; San Diego, CA; Basking Ridge, NJ; Cincinnati, OH; Lexington, KY; or Austin, TX. The ideal candidate could be home based.
 
The Director, Global Medical Writing & Scientific Communications provides leadership and support for the development of clinical documents and scientific publications, providing high-level input in ongoing departmental and project-based strategic planning.
 
Responsibilities:
  • Develops, maintains, supervises and evaluates a global department of technical / regulatory medical and scientific writers
  • Actively supports ongoing business development efforts related to medical and scientific writing and report processing services
  • Conducts strategic planning
  • Manages, coaches and guides development of direct reports and effectively delegates, as required
  • Participates in presentations to clients for general capabilities as well as specific project proposals
  • Provides scientific direction to internal and account teams and to clients and authors, as needed
  • Ensures quality standards of writing among staff and contractors are met and are periodically reviewed, as needed
  • Participates in the recruitment of employees and contractors
  • Provides input to maintain standards, work ethics, processes and procedures necessary to run a cost efficient department
  • Prepares and / or reviews global SOPs, as necessary
  • Monitors literature, including therapeutic, competitive and technical
  • Identifies training and development programs for self and staff
  • Maintains professional knowledge by affiliating with professional and technical organizations, and participating in applicable continuing education programs, conferences, seminars and workshops
  • Complete administrative tasks, as appropriate
Qualifications:
  • Bachelor's degree required; MS, MPH, PharmD, PhD or other advanced life sciences degree is preferred
  • Extensive experience in the preparation of clinical documents for regulatory submission, including clinical protocols, study reports and integrated summaries
  • Senior-level management experience in the area of medical writing, publications or communications
  • Strong knowledge of US and international pharmaceutical regulations, requirements and guidance documents associated with document preparation and submission
  • Knowledge of and experience with CTD content templates, electronic document management systems and information technology
  • Participation in the filing of CTDs, MAAs and NDAs
  • Good overall knowledge of the clinical trial process and GCP regulatory requirements for the conduct of clinical development programs
  • Proven ability to think creatively, meet deadlines and manage multiple tasks simultaneously
  • Ability and willingness to travel (up to 30%) 
Contact:
 
Jessica Warchal
Recruitment Sourcing Specialist · i3
1001 Winstead Drive · Suite 200 · Cary, NC  27513
Direct: (919) 678 4632 · Main: (800) 200 1245ext. 84632 · Fax: (973) 241 9623
Medical Writer
Nutley, NJ
 
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].
 
PharmAscent, A Division of The Ascent Services Group specializes in nationwide direct hire and contract placement for the Pharmaceutical and Biotechnology industry.
CMC Biologics Writer
New Jersey
 
Permanent, on-site position
 
Responsibilities:
  • Responsible for generating the technical content for CMC documentation required for investigational new drug applications, amendments, marketing applications and supplements/amendments.
  • Prepares technical sections for regulatory filings
  • Coordinate completion of CMC templates with Regulatory Affairs CMC
  • Summarize technical reports and documents
  • Working knowledge of project plans for those projects to ensure CMC sections are delivered on time
  • Serve as a member of multi-disciplinary teams organized to ensure project timelines are met and clinical and commercial supplies are available
  • Assist with preparation of an optimized work flow for document creation, review and completion.
Requirements:  
  • 7+ years industry experience with at least 1 year of authoring or handling regulatory documentation
  • Knowledge of US regulatory requirements with global regulatory experience
  • Technical knowledge of biopharmaceutical manufacturing process preferably in antibody manufacturing with expertise in a technical discipline a plus
  • BS//BA Biochemistry, Chemistry, Microbiology, Pharmaceutics, Chemical Engineering, advanced degree a plus
  • Knowledge of cGMPs
Contact:
 
Please apply online, or email Lindsey Summers at [email protected].
 
PharmAscent, A Division of The Ascent Services Group specializes in nationwide direct hire and contract placement for the Pharmaceutical and Biotechnology industry.
Principal Medical Writer
Cambridge, MA
 
We are seeking a talented, highly motivated team player who will be responsible for producing documents for regulatory submission. This is an in-house, permanent role.
 
Responsibilities:  
  • Produce and/or update Investigator Brochures, clinical protocols, clinical study reports, safety narratives, and correspondence with regulatory agencies in accordance with predefined timelines.
  • From listings, tables, and other sources of clinical information, produce cohesive, meaningful analyses and summaries in written and graphic formats.
  • Coordinate production of INDs, BLAs, or NDAs in cooperation with Regulatory Affairs and other team members.
  • Review draft documents and draft statistical output for accuracy and consistency.
  • Write and edit documents in accordance with established style guidelines.
Qualifications of the Ideal Candidate:  
  • B.S., M. S., or Ph. D. in a relevant field. At least 3 years of regulatory medical writing experience and 2 years of pertinent experience in the biopharmaceuticals industry. Experience with producing INDs, BLAs, or NDAs in CTD format is preferred.
  • Excellent writing and interpretive skills. Qualified candidates will be asked to submit a writing sample before being interviewed.
  • Expert working knowledge of ICH E2 and E6 plus CFR 312 and 314. Knowledge of Canadian and/or EU regulatory requirements is preferred.
  • General knowledge of applied clinical medicine and laboratory interpretation. Experience with large-molecule drug development is preferred.
  • Advanced knowledge of Microsoft Word, Excel, and PowerPoint. Familiarity with other graphics software is preferred.
  • Experience with an electronic document control and management system.
Contact:
 
If you're interested or have any questions please don't hesitate to call or email:
 
Matt Soloperto | Consultant
Life Science Division
The Bowdoin Group | www.bowdoingroup.com
Senior Medical Writer, Contract
San Carlos, CA
 
We have an urgent requirement for the following contract medical writing position, located in San Carlos, CA, in the San Francisco Bay Area. The contract is for 3+ months.
 
Responsibilities:  
  • Responsible for researching, writing and editing clinical reports, summarizing data from clinical studies for submissions to the FDA and for publication and/or presentation.
  • Will also assist in the development of formats and guidelines for clinical documentation.
  • May support CRAs and MDs in clinical protocol development.
  • Remains informed of the latest professional, technological, and regulatory developments in medical writing, as well as therapeutic areas.
Essential Duties and Responsibilities:
  • Assists with the management and execution of all clinical writing activities outlined in the Project Clinical Development Plans (CDPs).
  • Assists with the development and ongoing management of Departmental Guidelines management system, writing style guide, and departmental templates, such as protocols, investigator's brochures, final clinical study reports, and IND sections.
  • Provides and manages internal and external writing activities.
  • May supervise the activities of junior medical writing staff.
Minimum Qualifications:
  • A minimum of 8 years medical writing experience is required.
  • A minimum of 5 years experience in a pharmaceutical, biotech, or CRO medical writing position is required.
  • An ability to create effective presentations from raw data is essential.
  • An ability to interpret statistical and clinical data is essential.
  • Must have an ability to work well with others in high-pressure situations.
  • Must have demonstrated problem solving abilities.
  • Strong organizational skills are required.
  • Strong written and verbal communication skills are required.
  • An understanding of clinical research, biostatistics, and regulatory affairs is required.
  • Must have experience writing clinical protocols, clinical study reports, IND sections, abstracts, and manuscripts.
  • Good computer skills are required. Working knowledge of MS word, Excel, Power point, Lotus notes is a plus. 
Education:
 
A minimum of a Bachelors/Masters degree in a scientific discipline is required. Equivalent experience may be accepted. 
 
Contact:
 
Robin Reyes
Staffing Manager
Sai People Solutions, Inc.
"Celebrating 25 Years of Consultant Satisfaction"
Toll-Free: 866-313-6849 x 124
Phone: 281-358-9411 x 124
EFax: 1-(773)-303-1370
Email: [email protected]
Web: www.saipeople.com
Medical Writer
Winston-Salem, NC
 
A small, growing, biopharma in Winston-Salem, NC, is looking for a Medical Writer.  This is a permanent, full-time, in-house position and the incumbent will be the sole writer. Position is in the Clinical Development & Regulatory Affairs Department. Must have a minimum of a Bachelors degree and Five years' industry experience writing regulatory and clinical documents. CNS experience a HUGE plus.
 
Salary into the $90s plus bonus and relocation assistance. Reports to the Sr. Director, Biometrics.
 
Job Description:  
 
The Medical Writer is expected to deliver high-quality regulatory documents that meet ICH standards, project timelines, and regulatory specifications. The responsibilities of the Medical Writer includes management and preparation of a variety of clinical documents, including protocols, clinical study reports, narratives, worldwide regulatory submissions, and investigator brochures for clinical trials.
  • Work with key interface partners (e.g. Project Management, Statistics, Programming, Chemical Manufacturing, Regulatory Affairs) to facilitate completion of complex documents, including protocols, clinical study reports, investigator brochures, and other clinical and regulatory documents.
  • Participate ad-hoc on relevant project teams and task forces, and provide guidance to clinical, safety, nonclinical, Quality, and CMC functions on a wide range of issues related to document preparation and production.  These include US and international regulatory guidance and requirements for content and format, organizational requirements (style, electronic integrity, and process), and project- or therapeutic area-specific guidance related to content and organization of specific documents.
  • Use project management skills to create timelines, track, review, and ensure timely completion of high quality regulatory and clinical documents.
  • Participate in planning of analysis and data presentation to be used in study reports or summary documents.
  • Review data to determine the appropriate tabular and textual formats, and the clarity, logic and order of presentation.
  • Develop and update specifications, format production elements, and track regulatory documents and artwork used in regulatory documents.
  • Develop and update Targacept editorial style standards, provides guidance to project teams regarding regulatory submissions, and develop and update general writing guidelines.
  • Document, review, update, and maintain Standard Operating Procedures (SOPs) for all medical writing activities in accordance to good Clinical Practices and Federal Regulatory requirements.
  • Participate, as needed, in the creation of SOP templates for all functional areas and with QA staff.
  • Participate in Clinical Operations meetings and training initiatives, project team meetings, and maintain relationships with other internal departments as necessary.
  • Other duties as assigned. 
Contact:
 
Jenny Nichols
Senior Recruiter
ClinFinder
Tel: 858-412-4230
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Comments or questions? Email Susan at [email protected].