Medical Writing Word Processing Coordinator I
The main crux of the word processing role is formatting, what does that even mean you ask? Good question, I had no clue either. So the word processors are really in essence responsible for making sure that clinical documents are clean, can be navigated (correct page numbers, table of content, cross reference links bookmarks, etc), have no background document properties that cause issues, have the correct dates and file name per client standards, and follow regulatory guidelines with regards to margin/font size, border shading, etc. So while the role does apply some light copy editing (i.e. checking content for correct spacing), its mostly focused on the overall format of the document. The role really requires someone who can be detailed and focused when manipulating the format of technical documents so that they comply with standards. The majority of the work is done in MS Word. We do have some word processors with writing backgrounds, content creation/editing/AMA style/writing/design experience is not necessary or even really relevant. Couple of points:
• Copy editing experience would likely be tangentially relevant to this role, given its need for attention to detail, but copy writing experience likely would not. It seems like most copywriters work primarily in design software that is a lot different from MS Word.
• In the same vein, marketing/communications/creative writing or designing promotional/advertising/website layouts would not be directly relevant experience (though I would possible still consider candidates, especially if they have an interest in the life sciences/drug development industry). But working on promotional layouts would not be
• I would consider candidates with strict scientific background, but would be helpful if their resume also highlighted some technical writing/documentation or other experience that requires an attention to detail with regards to document structures/format/styles
The Medical Writing Word Processing Coordinator is responsible for formatting, proofing, and completion of Clinical Protocols, Clinical Study Reports, Investigator's Brochures, and other related clinical regulatory documents. Provides document formatting support to Medical Writing, Clinical, and, other functional areas, ensuring successful preparation of high-quality, submission-ready documents. Ensures completion of work to meet multiple client deadlines. Ensures styles and formatting are consistent with defined eSubmissions standards so that the documents created in MS Word correctly render to PDFs.
Processes, proofreads, verifies and manages various clinical regulatory documents, ensuring they are submission-ready for publishing with an appropriate level of accuracy and consistency.
Communicates regularly with colleagues and management regarding timelines and conflict to timelines for word processing requests, eSubmissions issues, and document completion dates.
Provides ongoing support for Medical Writing, Clinical, and, other functional areas; acts as a liaison between eDocs support and Medical Writing as needed.
Responsible for effective communication among team members.
Ensures all electronic document deliverables are processed and completed in alignment with timelines.
Accountable for meeting the main objectives of assigned word processing projects within established timelines and with an appropriate quality level.
Ensures document styles and formatting are consistent with defined eSubmissions standards, so that documents created in MS Word are correctly rendered to PDFs.
Confirms formats and styles are consistent with those in the clinical regulatory templates, when applicable.
Accountable for providing services and results on time, accurately and consistent with expectations.
Populates document properties and ensures correct naming conventions are used per the eSubmissions System file naming conventions.
Accurately and timely maintains document tracking for all documents.
Ensures literature citations are correct. Performs literature searches. Maintains knowledge of eSubmissions styles and formatting standards.
Must continually train/be compliant with all current industry requirements as they relate to regulatory submissions, including electronic submission/approval standards.
Participates in process improvement activities.
Bachelor of Science or Bachelor's degree in English or Communications
Superior attention to details.
High level computer skills. Excellent working knowledge of software programs in Windows environment (strong MS Word experience)
Outlook, Excel, PowerPoint is preferred
1+ year relevant pharmaceutical industry experience in a related area such as medical writing, quality, regulatory, clinical research, or product support/Research & Development desired.
NOTES FROM INTAKE CALL
1) What hours and days will this person be working? Mon-Fri Regular Hours
2) What are the top 5 skills/requirements (over and above the required qualifications) this person is required have?
1: Has leadership attributes
2: Eagerness, enthusiasm
3: Desire to work for client
3) What years of experience, education, and/or certification are required? Can be a resent graduate (As this is an entry level contract position at client, open to hiring new grads or grads interested in a potential career at client.)
4) What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification?
5) What is the environment that this person will be working in (i.e. group setting vs individual role)? Group
6) Is any testing required for this role? No
7) Does this position offer the ability to work remotely on a regular basis or is it an on-site role? If remote opportunity exists, what are the options (i.e. 1 day remote, 4 days on-site)? Onsite
8) Other notable details from the hiring manager about this role: Starts as 6 month role, but has opportunity for incremental 6 month extensions.
Spotlight Call Notes:
Formatting docs after they have been written and ready them for FDA submittal. Making sure it follows required standards. Table of contents is correct to route to the correct page, using MS Word, then rendered into an PDF. Strictly formatting role.
It is not editing. This is formatting only. Not a writing or creative position. Formatting only.
Uploading docs into electronic submittal portal and maintaining hierarchy of each doc. Computer skills are needed. Do not expect experience with this, but basic understanding of Word and the ability to use computer skills and learn new skills is needed.
Great attention to detail needed, some work being done is getting to the nitty gritty of the format of a doc, and how to name the file, etc.
Interest in life science industry. Great role to learn what goes into a drug creation process. English degrees are good as they would have some of this, but if looking to writing, this is not a good fit for them. A long training process. Given practice docs in the beginning to work on them, then are graded. This is a very independent positon once trained and up and running. Ability to self teach. Lots of group and team environment, communication skills. Firm leadership aspects, being able to step up and make suggestions, assist others. Raise your hand to do more as time allows.
Need people who can sit at a computer and work, learn from their mistakes and go from there. Not a lot of hand holding through training.
Fresh grads work great in this role and have done great work for us in the past.
Can see drug development from the ground up – someone looking to get into life sciences.
Experience with Journalis, PR, Communication work? English, Science degrees, Journalism, all would work, just be sure they understand they are formatting only. No writing. No editing of what has been written.
Clinical research background works, they are not manipulating clinical data. The knowledge helps them to navigate the documents they would be formatting. Open to background if they have the other aspects needed for this position.
There is no editing – very, very light copy editing, in the sense that client has certain ways of doing things, so making sure study is named correctly. They do not manipulate any words, all formatting of doc, font size, borders, tables, cross referencing, do not work on actual text at all.
Best: College grads with Engish or Science degrees.
Interview Process: 30 minutes with Hiring Manager. If asked to go to 2nd interview, this will consiste of 3 to 4, one hour interviews with team members.