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| 7 May 2010 Published weekly by Biotech Ink, LLC | Vol 3 No 13 |
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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 that are closely related to medical writing, or that have a strong writing role, regardless of their titles.
If you receive calls about staff or contract medical writing 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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Medical Writers, Contract Telecommute Positions |
This is an opportunity for several contract medical writers who have experience writing for ophthalmology indications with respect to drugs, biologics, and/or medical devices. Medical writer's experience should include manuscripts destined for publication in peer-reviewed medical literature and/or regulatory documents (eg, clinical study reports, protocols, investigator brochures, INDS, NDAs, BLAs, and/or PMAs, and preferably experience with the eCTD submission format).
Contact:
PLEASE READ CAREFULLY: Qualified contract medical writers should submit the following information:
(1) resume with a cover letter
(2) a representative medical writing sample (please do not send samples containing proprietary information)
(3) a full description of depth and scope of specific opthalmology medical writing experience
(4) requirements for compensation (hourly rate). Email all applications to Susan Caldwell at caldwell@biotechink.com (no calls, please). Note: C andidates will be contacted for further discussions only if they have submitted all of the listed items. |
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Lead Medical Writer King of Prussia, PA | |
Job Description:
This is a full-time, permanent employee position (NOT Contract, NOT Temp).
The position is located near King of Prussia, PA, and relocation assistance is offered, along with base salary, 15% bonus, and stock options. Reporting to the Head of Medical Writing, the Lead Medical Writer will be responsible for leading the medical writing activities for multiple projects or a business unit.
Responsible for timely preparation of investigators' brochures, study reports, integrated summaries, clinical overviews, risk management plans, contributions to briefing documents, response documents, and other IND/CTA or global regulatory submission documents, ensuring high quality with regard to scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes.
Supports the clinical project team(s) as the Medical Writing representative and oversees/coordinates work of other writers (internal or contractors).
Leads efforts for establishing departmental guidelines and cross-functional initiatives.
Responsible for resource assessments within assigned projects/business unit. Must be able to work with a high level of independence and effectively in a team environment, and must have strong scientific interpretive, organizational, and project management skills.
Responsible for all medical writing activities within assigned projects/business unit.
Actively supports clinical project team(s), representing Medical Writing and bearing responsibility for timely and accurate MW deliverables, negotiating timelines and procuring resources, as necessary.
With a high level of independence, writes, edits, or otherwise facilitates completion of clinical documents (all document types).
Manages writing, editing, QC, and publishing activities for programs within assigned project/ business unit.
Delegates and manages clinical project writing activities assigned to contract medical writers.
Proactively prepares writing plans for projects, including contingency plans and issue resolution strategies.
Provide strategic direction to the clinical project team relative to consistency of key messages across documents within a project and regulatory requirements/guidance for submission documents.
Mentor supporting medical writers, and ensure the quality and timeliness of their deliverables.
May have more junior level writers as direct reports.
Leads departmental and cross-functional process improvement initiatives.
Contributes to departmental strategic planning.
Education & Experience Requirements
PhD or equivalent degree in a relevant scientific/clinical/regulatory field preferred, with
at least 7 years of broad-range experience in clinical/pharmaceutical development
Global regulatory submission experience
Key Skills and Competencies
Excellent writing skills
Ability to understand and interpret clinical and scientific data; ability to define data presentation to meet key messages constructed by the clinical team
Strong oral and written presentation skills
Ability to interact effectively with team leaders/members and proactively facilitate effective information exchange/communication (including problem solving and issue resolution)
Knowledge of current regulatory requirements and guidelines applicable to clinical research (eg, GCP)
Understanding of regulatory guidances regarding content for various documents including, but not limited to, ICH E3 (CSRs), ICH E6 (IBs), ICH M4 (module 2 summaries), ICH E2E and EMEA guidance (RMPs)
Strong knowledge of MS Word, Excel, PowerPoint, and Outlook
Working knowledge of template use for document creation, and ability to work with different template styles and types.
Ability to prioritize multiple projects
Contact:
Please send resume prior to calling:
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Analyst-Pharma/Junior Consultant New York City |
Job Description:
Analyst-Pharma / Junior Consultant with a New York firm offering early stage development evaluation, product assessment, reimbursement, portfolio management, resource capacity planning, drug approval, regulatory compliance, channel strategy optimization and investigational new drug application (INDA). Eligible candidates should have 2-3 years experience in a consulting firm offering pharma advisory services. Offering $80/100.
Contact:
Mel H Lipton, The Winchester Group, Executive Search
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Medical Editor/Writer, Contract South San Francisco, CA |
Medical Editor/Writer position available in South San Francisco, CA. 8+ month contract.
Duties:
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 (eg, Regulatory or Clinical Science) 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.
Skills:
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, 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.
Education:
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:
Tracey Rawl
Sr. Technical Recruiter
XRoads Consulting, LLC.
Tel: 888-861-5053
Fax: 888-316-0971 Email: trawl@consultxroads.com
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Senior Medical Writer, Contract Deerfield, IL |
Length of Assignment: 6 months + extensions
Start Date: As soon as possible
Location: Deerfield, IL (northern suburb of Chicago; no possibility for remote
Objectives:
Executes medical writing activities for projects in accordance with applicable US and international regulatory regulations and company requirements under the supervision of the Manager, Medical Writing
Assumes primary responsibility for preparation of key regulatory response documents and documents supporting major regulatory submissions, and assists the manager in coordinating and evaluating the activities of other contributors (including contract writers and CROs)
Assists the manager in formulating writing approach, developing timelines, and assessing resource requirements for key documents and regulatory submissions
Participates on relevant project teams and task forces, and provides guidance to clinical, safety, nonclinical, and CMC functions on a wide range of issues related to document preparation and production, including US and international regulatory guidance and requirements for content and format, company requirements (style, electronic integrity, and process), and project- or therapeutic-area-specific guidances related to content and organization of specific documents
Accountabilities: Prepares documents for submission to FDA or other regulatory agencies, in accordance with team input, with minimal oversight from the manager Serves as lead writer for important regulatory response documents and key components of regulatory submissions As required, coordinates the activities of contract writers (on-site or external), provides review and substantive editing of contributions, and mediates resolution of issues Functions independently on teams and task forces, and provides guidance for document preparation and production to team members from other functional areas (nonclinical, safety, CMC, clinical) Provides leadership on functional teams that address requirements or issues related to document preparation and production Assists the manager in formulating writing strategy for key response documents and regulatory submissions, including organization, content, timelines, and resource requirements; may represent medical writing in cross-functional teams or task forces that guide planning and execution of key documents and regulatory submissions Education and Experience:
Required:
Bachelor's degree in science, health profession, journalism, or English Minimum of 4 years experience writing for pharma or biotechnology Electronic document submission experience a plus Experience as writer for key documents included in major regulatory submissions Preferred:
Advanced degree in science, health profession, or journalism Knowledge and Skills: Clear understanding of clinical development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission Understanding of FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to document preparation and production (including CTDs) Demonstrated problem-solving and interpersonal skills that facilitate effective interactions within cross-functional teams and with external providers Ability to address issues and generate solutions in the absence of intervention by management Contact:
Jane Pondel Sr. Clinical Recruiter Delta Pharma, a Randstad company Four Parkway North, Suite 120 Deerfield, IL 60015 Tel: 847-527-6118 |
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Medical Communications/Publications Medical Writer Plainsboro, NJ |
Medical writer must be able to work on-site; cannot be remote.
Job Description:
To work with authors to develop complex scientific manuscripts, abstracts, posters, oral presentations, and other printed materials to support the clear scientific communication of products Coordinate and integrate scientific and medical input from internal and external authors to meet publication deadlines with peer-reviewed journals and international congresses To provide professional, expert advice to the medical and clinical teams on all matters relating to the production of publications To distill, share and apply best practices to achieves industry-leading status in speed and quality of publication production Knowledge/Experience Desired: Advanced degree: MD, PharmD, or PhD plus 2 to 3 years medical writing experience. Immunology experience preferred Demonstrated strong writing skills as evidenced by publications in peer-reviewed journals Analyzed and interpreted complex data from a broad range of scientific disciplines Knowledge of statistics and their application to the interpretation and presentation of clinical data Experience in producing scientific posters, manuscripts and abstracts Experience working with project authors Demonstrated ability to manage timelines and quality of work using strong organizational, communication, facilitation and interpersonal skills in a cross-functional team Understanding of documentation requirements related to submission of manuscripts to scientific and medical journals Highly skilled in the use of PowerPoint Able to meet tight deadlines PubStrat experience a plus Contact:Amy E. Fink Clinical Recruiter MedFocus, LLC 8600 W Bryn Mawr, Suite 700 Chicago, IL 60631 Tel: (773) 632-1785 Fax: (866)439-9491 Mobile: (847)636-0770 afink@medfocus.com |
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Medical Writer, Contract Telecommute Position |
Need contract medical writer for writing SOPs. Looking for a potential medical writer candidate to suggest the SOPs a company would need with a 1-page employment proposal. The medical writer will be hired based on this proposal. The Proposal task is to suggest the highest-probability SOPs that a pharma client would ask a CRO for, and how long it will take to write each SOP and what SOPs, based upon their experience, they should provide to a CRO. Example: SOPs might be for writing clinical study protocols, INDs, or patient narratives, or for GXP auditing services. The president thinks each SOP will take 4 to 6 hours to write, with 30 minutes to 1 hour for revisions; the medical writer's job is to suggest otherwise, and IF she is off-base to explain why each one will take the time it takes in the proposal. The job can be performed from offsite. Start date is ASAP. The right candidate will have done this before and can hit the ground running. This medical writer will report to the president of the company, and the expectation is to get the job done correctly in the most efficient manner possible. Only one person will review the SOPs when written (the president). Once hired, the medical writer will be given an SOP template. Clients are Pharma, Device, Biologics and biotech companies. Contact:Amy E. Fink Clinical Recruiter MedFocus, LLC 8600 W Bryn Mawr, Suite 700 Chicago, IL 60631 Tel: (773) 632-1785 Fax: (866)439-9491 Mobile: (847)636-0770 afink@medfocus.com |
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