Monday, April 5, 2010

Scientific Medical Writer Position

This job is in in Southern California, but relocation assistance is offered.

Responsible for writing and editing key Global Safety and Epidemiology (GS&E) documents for global regulatory submissions, including Periodic Safety Update Reports (PSURs), Risk Management documents (RMPs and/or REMs), post-marketing sections of NDA/MAA/INDs, and post-approval regulatory commitments as needed. Will work primarily with Global Safety Scientists, Global Safety Officers, and Epidemiologists to coordinate, prepare, review and format GS&E documents and reports with well organized and effectively summarized safety information, with high quality and within predetermined timelines. The Professional will support consolidation of Team/Reviewer comments and questions and conduct data quality checks as needed.

This is a position involving multi-disciplinary interaction within the various functional groups of GS&E as well as outside contributing departments, including Regulatory Affairs, R&D Clinical Development, Medical Affairs, Marketing, and on occasion Senior Management, Therapeutic Area Leads, and the Chief Medical Officer.

The Professional is responsible for tracking progress of assignments and for assisting with multiple ongoing projects. Helps implement new/modified departmental processes (SOPs, WIs, templates and forms, etc), and must operate with minimal supervision. Serve on cross-functional committees and teams, as applicable. Excellent oral and written communication skills are required, with a strong knowledge of, and experience in interpreting and applying, global pharmacovigilance and risk management regulations and guidelines.

· Assist GS&E staff in authoring draft and final documents, applying scientific assessment to content, and completing according to predetermined timelines. Work with GS&E colleagues and contributing stakeholders to consolidate and address feedback/questions arising from Team Review of documents.

· Support Quality checks of safety data and information as applicable to ensure accuracy and high quality documents. Perform technical QC for published submissions as needed.

· Keep up-to-date knowledge of regulatory document requirements and assure documents meet Regulatory requirements as well as departmental standards for formatting, consistency, and adherence to company Styles. Apply a solid understanding of content and formatting requirements for PSURs, RMPs/REMs and post-marketing sections of regulatory filings (NDA, MAA, IND). Work with GS&E staff to produce/update Common Technical Documents (CTD) templates and other templates as needed.

· Attendance at team meetings or cross-functional committees

· Supports GS&E in maintaining tracking system for safety related documents/deliverables, and assists with document archival in electronic document management systems.


Education and Experience

· An advanced degree (or equivalent experience) in health care, or other suitable combination of education and 5+ years of specific experience.

· Experience preparing PSURs, RMPs/REMs, and other post marketing safety reports for regulatory agency submission

· Understanding of EU and US Pharmacovigilance, Risk Management, and post-marketing safety requirements

· Familiarity with medical terminology, and MedDRA

Essential Skills and Abilities

· Excellent planning, organization, and communication skills (written and oral).

· Ability to compose and review scientific documents for content, grammar and style, with high degree of attention to detail and in consideration of stakeholder feedback.

· Assertive individual with a proven ability to work effectively and flexibly with others and with a team-oriented effort.

· Ability to track progress and manage multiple projects.

· Good understanding of requirements for post-marketing modules of the eCTD.

· Thorough knowledge of word processing and spread sheet programs (MS Word and Excel), Adobe Acrobat. Experience with electronic document management systems. Competency with automated data collection systems


John Peace
P: 215-750-7500 F: 215-750-1398 C: 215-630-6848

Regulatory Writing Position

Responsible for researching, writing, and editing materials for regulatory submission. As a member of the medical communications team, relies on instructions and pre-established guidelines to perform the functions of the job.

Essential Functions:

Primary responsibilities are as follows:

1. Works with data management and clinical operations groups to review and interpret clinical trial data
2. Compiles, writes, and edits regulatory materials (IND/NDA), with specific emphasis on clinical study reports, investigator brochures, and SAE narratives
3. Assists other writers in the compilation, writing, and editing of regulatory materials
4. Manages review and revision processes for multiple, concurrent projects
5. Ensures quality of content and format of publications in accord with applicable regulations, guidelines, and corporate SOPs

Skills Required:

1. Knowledge of FDA regulatory requirements, Good Publication Practice (GPP) and ICH guidelines, including strong familiarity with the eCTD
2. Strong medical and/or scientific writing skills
3. Ability to work well in a team environment, with the ability to work effectively independently
4. Efficient project management skills
5. Good work ethic

Education or Equivalent Experience:

• Bachelor’s degree in applied or life science or communications, with a 3-5 years of medical, regulatory, or clinical writing experience in the pharmaceutical or biotech industry, or equivalent training and work experience. An advanced degree is preferred. Ophthalmology experience a plus.

Remuneration based upon experience.


If interested, please forward résumé and salary requirements to

Medical Communications Position

The role of the Medical Writer, within the Medical Communications Department, has three primary components consisting of (1) Research – taking sole ownership of subject matter through guidance from internal subject matter experts or individual researching; (2) Organizational Skills – maintain a structured, disciplined process and organization to produce consistently high quality, on-time work product; and (3) Communication – impart the value and progress of projects to other members of the Ora team, interact in a professional manner with multiple layers of educated individuals, know your audience and write accordingly.

Ensure a top-tier quality-product required to satisfy both very demanding internal and external clients.

• Set Strategic Growth Direction –
o Work with Manager of Medical Communications to plan future individual growth.
o Recognize potential business building opportunities with current clients.

• Lead the Writing –
o Take ownership of project subject matter through expert seeking of resources.
o Define the objectives and key messages clearly and concisely to all parties involved, prior to commencing project work.
o Ensure that all materials submitted to journals/clients/regulatory agencies are accurate and complete according to guidelines/requirements
o Write like your life depends on it.
o Maintain and track review process to ensure on-time completion and identify timeline problems prior to missing deadline.
o Provide constructive feedback to authors, reviewers and subject matter experts to constantly improve the workflow and product quality – do not be a stenographer, be a writer!

• Build and Maintain Relationships
o Interact with journal editors to place articles that are both requested by editors and those that are not requested.
o Interact with internal and external clients to gain an understanding of business needs and marketing initiatives to enhance the messaging platform.

• Flexibility Across Mediums
o Own project subject matter across and produce work across the entire life cycle of information including:
 Peer Review Journals (New England Journal of Medicine style)
 Presentation Slides
 Product or Therapeutic Category Fact Sheets
 Trade Journal Articles (Review of Ophthalmology, Ocular Surgery News)
 Scientific Meeting Abstracts and Posters

At Ora, your values, abilities, and track record of success are more important than direct experience. That being said, an ideal candidate would have the following:

• Advanced Degree preferred, but not required.
• Strong competencies in the following areas: intellect (the ability to learn, understand, innovate, and apply analytical rigor), personal skills (integrity, candor, excellence, etc.), and interpersonal skills (oral and written communication, emotional intelligence, customer service, etc.)
• Prior experience writing in the non-regulatory pharmaceutical space (Medical Communications, Medical Education) in the Ophthalmology or Allergy therapeutic areas.
• Proven ability to multi-task and follow-through and work both independently or as part of a larger team.
• Proficiency with Microsoft Office and presentation software programs (PowerPoint, Keynote).
• Enjoy and love writing, do not use it as a stepping stone.

To apply, go to