6 May 2011                    Published weekly by Biotech Ink, LLCVol 4 No 10

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Inside the Insider

Open Jobs and Contract Opportunities
 
Medical Writer/Senior Medical Writer; White Plains, NY
 
Senior
Manager, Medical Writing; Princeton, NJ
Contract Medical Writer; Stamford, CT

 

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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 [email protected]. We'd be delighted to publish such positions in the next issue of the Insider.

Medical Writer/Senior Medical Writer

White Plains, NY


Summary

The Medical Writer/Senior Medical Writer will write standard Medical Writing documents for a growing biopharmaceutical company in this on-site position. Their focus is in Oncology, Ophthalmology, and Inflammation, among others. 

Essential Duties and Responsibilities

 

Works with the clinical team and/or other Medical Writers, to write or help to write the following documents: Clinical Study Protocols, Clinical Study, Protocol Amendments, Clinical Study Reports, Investigator brochure and other documents, as needed.


Tracks writing projects, and ensures adherence to regulatory guidelines and department document standards.


Ensures maintenance of document standardization through use of model documents/templates and appropriate peer review.


Liaises with study director and/or medical monitors to shape and review content of documents. Follows up with other functional groups for materials needed for document completion.


Resolves issues and escalates problems, as necessary.


Requirements


Basic knowledge of the clinical research process and regulations/guidelines required.


Scientific and technical reading, writing and editing skills required.


Strong organizational, interpersonal and communication skills.


Must be able to develop and present varied and unique ideas. Effective influence and relationship management skills required.


Bachelor's degree (BS) from an accredited college or university


Minimum of 5 years medical writing experience.

Additional Details

Previous biotech experience would be helpful

No need for publications experience

This position will be working primarily with CSRs

Need to include writing sample with CV

Contact 

Please apply by email Laura Walton at [email protected]. If you know of someone who would be a good fit, feel free to forward them this information.

 

Senior Manager, Medical Writing

Princeton, NJ


Summary 

In this on-site position, the Senior Manager, Medical Writing, is expected to deliver high-quality regulatory documents in accordance with regulatory guidelines that meet ICH standards, project timelines, and specifications set forth for the projects. The "hands-on" Medical Writer is responsible for preparing clinical summary documents, including (but not limited to) Integrated Summaries of Safety and Efficacy for NDAs, MAAs, and/or NDA Supplements/Type II variations in eCTD format. The responsibilities also include the coordination and preparation of Meeting Content Packages, and responses to regulatory authorities as well as the management and preparation of a variety of clinical documents including clinical study reports, narratives, investigator brochures for Phase I to IV clinical trials, and drug safety related documents such as Periodic Safety Update Reports. Competency in the use of Documentum (or a similar document management system) is required, while some knowledge or experience with electronic publishing tools is desired. Reports to Executive Director, Corporate Medical Biometrics and Medical Writing.
 

Essential Duties and Responsibilities

Prepare/coordinate and deliver high quality clinical sections of submission (IND/NDA/CTD) and responses to regulatory authorities, and implement medical writing activities. Interact with multi-disciplinary team members (regulatory, physicians, statisticians, clinicians, data managers, and drug safety group) as applicable. Discuss the objectives, timelines, and documents to be generated, coordinate contributions from other groups and do the needed writing and pull together the documents in an efficient, non-disruptive manner for submissions to regulatory authorities.


Prepare/coordinate clinical documents as required (e.g., Clinical Trial Reports (Phases I - IV) and associated appendices, Investigator's Brochures, Periodic Safety Update Reports, Annual Safety Reports, Ad Hoc Safety Reports, Clinical Expert Statements, clinical sections of IND/NDA/CTD). Resolve conflicting comments among reviewers and collate comments for submission to consultants/CRO, as necessary.


Manage the activities of internal/external resources and medical writing vendors (i.e., individual consultant medical writers and contract research organization (CRO) medical writers).


Manage projects within predefined budget, predefined internal resources, and time constraints.


Education and/or Experience


BS degree, advanced degree/Life Sciences preferred.


7 to 10 years of experience in regulatory writing within the pharmaceutical industry, including managing 3-4 global registration dossiers.


Experience with diagnostic imaging agents preferred.


Experience working with an electronic based document management system.


Vendor/consultant management experience preferred.


Experience with interactions with regulatory groups and formulating regulatory strategies desirable.


Core Relationships

Teams within the Global Groups and Medical and Regulatory Affairs department: Executive Medical Leaders, Clinical Research, Data Management, Biostatistics, Drug Safety and Pharmacoepidemiology, Regulatory, Preclinical Research

Also: External Medical Writing Vendors (individual consultant writers and CROs)


Contact 

Please apply by email Laura Walton at [email protected]. If you know of someone who would be a good fit, feel free to forward them this information.

 

Contract Medical Writer

Stamford, CT


Waiting on approval for work from home 2-3 days a week and office based the rest of the week.

Summary
 
 
The Medical Writer/Sr. Medical Writer will write standard Medical Writing documents.

Essential Duties and Responsibilities

Works with the clinical team and/or other Medical Writers, to write or help to write the following documents: Clinical Study Protocols, Clinical Study, Protocol Amendments, Clinical Study Reports, Investigator brochure and Other documents, as needed.

Tracks writing projects, and ensures adherence to regulatory guidelines and department document standards.

Ensures maintenance of document standardization through use of model documents/templates and appropriate peer review.


Requirements

B
asic knowledge of the clinical research process and regulations/guidelines required.

Strong organizational, interpersonal and communication skills.

Minimum 2-5 years of medical writing experience.

Contact 

Please apply by email Laura Walton at [email protected]. If you know of someone who would be a good fit, feel free to forward them this information.

 

 

 

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