Month: August 2016

Surviving the HR Screen from job posting to interview – advice from industry experts

Posted on August 25, 2016 Updated on December 15, 2017

Learn about what happens on the other side when you submit your application for a job posting from seasoned industry experts! What is the best way to format your résumé so that it doesn’t get trashed?

Invited recruiters:

Alicia Rethage – Consults for biotech companies. Director of human resources.

Sean Conneely – Responsible for all recruitment in the US for Abcam. Also works as a freelance writer in his spare time.

This entry was posted in AltAc, Career Development, Job Listing, Panel, Resume.

Regulatory Affairs: A Day in the Life Of.

Posted on August 23, 2016

Interested in a career in regulatory affairs? Click through to find out more!

Written by /u/LifeAfterLifeScience and copied with permission

Communicating

At the most basic level, you act as a trader in information. You’ll stand at the midpoint between a vast variety of departments, experts and regulators – and you’ll be keeping information flowing between each and every one of them. Emails, reports, meetings, phone calls, the job involves keeping people up to date and in the loop. Communication lies at the heart of regulatory affairs, so expect to do a lot of it.

Organising

Are you organised? You’d better be – you’ll be juggling multiple projects at any one time, plus various meetings and whatever emergency has come up this time. Being able to keep track of these requirements is a must. You’ll need to be able to plan both in the short term (today’s chaos) and the long term (what is our 4 year development plan?). This is where the typical scientific background, with its multitasking of experiments, writing, and meetings, really comes in handy.

Managing

The job title is Regulatory Affairs Manager, and so it’s fairly clear that there’s management involved. But it’s not ‘management’ in the sense of having people reporting to you and doing the tasks you assign them (well, not until later at least). Instead it’s managing people without actually having any formal authority over them – you can’t give orders, you’ll have to persuade, wheedle, nag, bargain, compromise and trade your way to your goals. This is not to say that people won’t want to help you, but each expert you approach will have a ridiculous number of demands on their time. Why should they help you? You need to be persuasive, and this is why interpersonal skills are one of the main talents HR looks for when hiring.

Writing dossier modules

Want approval to market your miracle drug? First you need to show that you know what you’re doing – that your product is safe, effective, and made in a (consistently) high-quality way. This is done via the dossier, a vast document split into numerous sections covering every stage of the development process and the future plans. As you’d expect, working on a product’s dossier takes up a lot of time. Whether it’s putting together the initial application or making updates to a previously-approved one, a regulatory career will revolve around the dossier.

Working with source documents

This is a pretty big change for people coming in from academia or research: you’re done with laboratory work. Others within the company will be doing protein analysis, clinical studies, purity checks – that’s not your job any more. Instead, you’ll take the work produced by these people (studies and reports), and use that as a basis for their own writing. You still need experience dealing with scientific data and methods (to understand what you are reading!), but the data is produced by others. Your job is to understand these source documents so that you can decide how much of it ends up in the dossier.

Providing regulatory advice

You aren’t just reading reports and writing dossiers. Because companies are always changing their methods (trying to optimise for cost and yield), you’ll be part of the change evaluation process – saying how much regulatory stress is involved in any given change. That clever idea to increase yields by a few percent is less worthwhile when the FDA demands several years of stability data first. Likewise, your advice will be needed to plan these changes. What will be needed to get approval for your drug? What kind of studies will be needed in the final submission? This is where regulatory affairs comes in.

Thoughts on transitioning into reg. affairs straight from the bench?
It depends on the company. Small biotechs will likely be looking for candidates with more experience however large pharma companies often hire people straight out of a PhD or postdoc and train them up.

Kind of interesting?

If this sounds like your area and you want to know more, then either drop me a question here or check out our short guide for life scientists on Amazon. Or both 😀

This entry was posted in AltAc, Career Development, Industry, Resources.

The Art of Scientific Storytelling with Rafael Luna, PhD

Posted on August 22, 2016 Updated on December 15, 2017

We were joined by Rafael Luna, PhD, a program director at Harvard Medical School by day and a scientific storyteller by night!

Take Home messages

· Genesis of Scientific Storytelling

o Publish or Perish (Academia)

o How to publish early and often?

§ Book: Amazon.com-The Art of Scientific Storytelling by Rafael Luna

o What is a story? It should have…

§ A beginning and end

§ Conflict and resolution

§ Compelling narrative

§ Logical series of events

o What is a hypothesis?

§ Educated guess

o Scientific research = scientific story
Hypothesis Validation = conflict resolution

· How to write the manuscript

o Audience Suggestions:

§ Outline

§ Mission statement for paper

§ Start with figures and then rearrange to make sense (like a storyboard)

§ Figure titles

o Important thing: actually put something down, need to start somewhere

o Rafael’s recommend order: Title, abstract, figures, results, discussion/introduction (and then return back to work on/tweak each section)

§ How do we compose a title?

· Title = conclusion

· One sentence conclusion of your work

o Narrative Elements: Protagonist, antagonist, conflict, scene, resolution, stakes (The Lion King Trailer as an example)

o Beginning and ending of narrative very important

o Titles that pack a punch

§ Put manuscript together from that powerful title

§ Hypothesis

· Different experiments/results that support hypothesis and build up to the climax result (which is the most important/interesting results that supports the hypothesis)

o You can build up to the climax result so that you can end the manuscript properly and keep the reader engaged

· Then validate your data

· Hypothesis is resolved: have everything in conclusion, everything in your needs to be substantiated by your results

· Have to be measured with your words and if you want to get it published need to have the data to support your statements

o Example: Luna et al Cell Reports 2012

§ The evidence for your antagonist/protagonist is in your work

§ Need to look at your work from different angles to properly put together your manuscript

§ Changing the focus between the antagonist/protagonist can change the manuscript substantially which can impact how your paper is received by editors/reviewers

o Examples of title variations:

§ Missing an antagonist?

· You end up not knowing the mechanism

§ If you have 2 protagonists…

· Difficult to go deeper in the mechanism because you have more than one protagonist to focus on

§ Processes can also be protagonists

§ Name your process or device to get more attention for your manuscript

§ If you have a drug without a proper name (combination of numbers and letters) you need to give it a name to let readers know what it means

§ Put as many narrative elements as possible in your title but if you can’t make sure it’s in your abstract

· Recommendations: publish along the way (through your graduate, postdoc career)

o Learn how to end a story (which is your mission/conclusion)

o Catalyze academic writing

· Let Rafael know if you publish well using his method (get your picture on his successful hall of fame)

· Use this method when it matters (to tell a logical story)

· Get feedback from your peers on your manuscript right away!

o The sooner you know where the pitfalls are the sooner you can fix them!

· Rafael@hms.harvard.edu contact information

This entry was posted in Career Development, Publishing, Resources.

[Job Listings] Clinical/Data Analyst/Scientist openings at Bracket

Posted on August 19, 2016

www.bracketglobal.com

Senior Clinical Scientist

Position Overview:

The Clinical Scientist designs and executes clinical services to enhance clinical trials. The Clinical Scientist partners with the sponsor clinical representatives to ensure appropriate project definition and ensures that clinical deliverables are in accordance with project scope. The Clinical Scientist directly participates in attendance at face-to-face and virtual training events, and may participate in business development opportunities.

Essential Duties and Responsibilities:Other duties may be assigned.

Clinical Responsibilities

· Collaborates with study sponsors to establish appropriate project definition

· Reviews protocol/CRF and provides feedback as appropriate

· Designs and ensures appropriate execution of project specific processes and data review methodologies; ensures appropriate training

· Ensures development of appropriate clinical content (e.g., qualification methodologies, didactic presentations) for rater training and qualification programs for study staff in clinical trials

· Evaluates data submitted in accordance with Endpoint Reliability programs and contacts raters, as appropriate, to gather additional information and provide feedback

· Ensures that project clinical deliverables are in compliance with quality control standards

· Proactively identifies and escalates potential project issues appropriately to project team, sponsor and/or manager

· Communicates with study site staff in accordance with project specific methodology/SOPs and documents interaction in the respective IT application

· Ensures compliance with quality assurance as outlined in SOPs/Clinical Operations Guidelines

· Ensures consistency of product with actual project scope and resolves ambiguities in collaboration with both internal and external project teams

· Monitors performance of external Clinical Experts

Management (Team Lead Only)

· Provides direct line management to Clinical Scientist I/II, Clinical Specialist, Clinical Associate, Sr. Project Assistant, and/or Project Assistant

· Conducts appropriate supervisory meetings, and monitors productivity

· Ensures appropriate training and career progression

Business Development

· Participates in business development opportunities as assigned (e.g., client meetings, bid-defenses, preparation of materials)

· Attends conferences and scientific meetings as appropriate

Administration

· Submits weekly report of activity to manager

· Participates in orientation and training of staff as appropriate

· Participates on committees as assigned

· Completes required trainings in a timely manner

· Enhances the Bracket’s Client Services business model by institutionalizing business processes, implementing best practices, templates, and seeking ways to work more efficiently

· Ability to perform all responsibilities of Clinical Scientist II, if required

Skills & Competencies

Education

· Masters Degree, M.D., Ph.D., Psy.D, Pharm.D., in healthcare-related field, with three years of clinical experience, which includes administration of psychiatric and/or cognitive scales OR

· RN with four years of clinical experience, which includes administration of psychiatric and/or cognitive scales

Experience

· Minimum of one year as successful Clinical Scientist II or equivalent

Personal Attributes

· Excellent writing skills

· Demonstrated strong analytical, organizational, creative problem solving and communication skills

· Ability to succeed in a fast-paced, entrepreneurial environment

· Basic knowledge of statistics

· Competency conducting patient interviews

· Comfortable with being videotaped

· Competency working with data and numbers

· Good negotiation and diplomacy skills

· Successfully manages own time, proactively identifies and prioritizes multiple tasks

· Ability to work with staff at all levels and across various disciplines

· Excellent computer skills including Word, Excel and PowerPoint

· Fluency in English (will be required to write, speak and understand English to conduct day-to-day business)

· Detail oriented

· Willingness to travel

· Willingness to maintain flexible schedule

Position Title: Data Analyst II

Department: Technical Delivery / Product Development

Reports To (Title): Senior Manager, Manager, Team Lead

FLSA Status (exempt or non-exempt): Non-exempt

Position Overview:

The Data Analyst II is responsible for working with the Technical Delivery / Product Development staff to process data changes.

Essential Duties and Responsibilities:

Note: Other duties may be assigned.

· Responsible for executing data change and data transfer requests.

· Periodic database exports and transfers to client based on a pre-determined subset of the structure and content.

· Writes and executes planned and ad-hoc SQL or SAS queries against MS SQL Database to extract data for Data Transfers and Reports.

· Creates and executes Data Change Guides (DCGs) and determines corresponding risk/impact assessments.

· Provides Data Transfers/Reports per approved Data Transfer Specifications.

· Reviews, provides feedback and approves Data Transfer Plans and final Data Change Form documents submitted to clients.

· Creates stored procedures to manipulate data for data-driven changes to IVR system functionality.

· Creates DTS packages for imports into study databases.

· Participates in special data-related projects as needed.

· Demonstrate extreme attention to detail and organization in all aspects of work.

· Follow Bracket Standard Operating Procedures for data change management, data transfer verification and risk/impact assessment documentation.

· Some technical support after-hours, on-call time may be needed.

· Other project work and responsibilities as required.

Skills & Competencies

Education

· 2-4 years of experience working in a data-driven environment.

· In-depth working knowledge of Structured Query Language (SQL), as well as Microsoft Windows 2000/2003/XP and the suite of Microsoft Office applications.

· Experience with standard data mining and data presentation techniques.

· Proven ability to handle multiple competing priorities in a fast-paced work environment with minimal direct supervision.

Competencies & Personal Attributes

· Must have excellent written communication skills, including the ability to effectively document procedures, processes and results.

· Demonstrated ability to meet deadlines & multi-task in a fast-paced work environment.

· Demonstrate extreme attention to detail and organization in all aspects of work.

· Must have very strong skills with Microsoft Office applications.

· Must be comfortable working with business users and technical teams.

· Familiarity with SQL Queries is a plus.

· Working knowledge of Visual Basic is a plus.

· Familiarity with GCP and 21 CFR Part 11 is a plus.

Position Title: Project Specialist, Client Services

Department: [eClinical or Scientific] Delivery Services

Reports To (Title): Associate Project Manager, Project Manager or Sr. Project Manager, Client Services

FLSA Status (exempt or non-exempt): Exempt

Position Overview:

Management and administration of projects at assigned pharmaceutical clients. The projects will include clinical data quality services (e.g., EDC, ePRO, IxRS, rater training, endpoint reliability, scale management, cognition, etc.) for said pharmaceutical clients.

Essential Duties and Responsibilities:

Note: Other duties may be assigned.

Data/Site Management (70%)

· Manage identification and resolution of clinical trial data inquiries/data changes and communication to internal and external multi-function resources within project teams

· Manage communications with client (e.g. pharmaceutical sponsor, CRO) and site personnel regarding site/study details

Facilitate weekly data review meetings with clinical trial study team leaders

· Own in-study/maintenance transactional project activities throughout entire project lifecycle, e.g. project variable fees, inter-department workflow assignment, issue escalation

· Prepare study materials, including system requirements, data transfer documentation, questionnaires, rater experience surveys, response sheets, and other documents as required

· Set up master systems, additional study hardware, study site folders, and data folders for clinical trial execution

· Coordinate and set-up data for system launch as assigned

· Design and configure unique project systems and manage data for each assigned project, utilizing proprietary IT applications (e.g. RDA, IR2, CDR PRISM, etc.)

· Produce data reports (e.g., weekly, interim, final, etc.) for submission to pharmaceutical clients

· Facilitate the closedown and archival of system databases

Training Event Management (15%)

· Attend international large scale training events (e.g. Investigator’s Meetings, Phase I site staff training) and facilitate training sessions (requires frequent overnight domestic and international travel)

· Coordinate with clients, vendors, and expert consultants to ensure all logistics, materials, and technologies necessary for successful training events are in place

· Independently facilitate virtual training sessions (e.g. LiveMeeting) including attendee registration, training execution and issue resolution

Administration (15%)

· Oversee project QC activities to ensure compliance within the enterprise Quality Management System

· Work within project team to develop and implement processes for projects

· Prepare and maintain in-study project plans, data management plans and study binders which will be executed in collaboration with Project Managers

· Provide weekly status reports documenting project activities, planned steps and issues

· Track monthly and quarterly metrics (variable fee budgetary items) and provide to Project Manager for invoicing

· Training and development of teammates as appropriate

· Leverage Project Assistant pool resources as required by project management

· Enhance the Bracket business model by institutionalizing business processes, implementing best practices, templates, and seeking ways to work more efficiently

· Contribute to the development, enhancement and testing efforts for enterprise IT applications (e.g. EDC, ePRO, IxRS, RDA, IR2, PRISM, CDR System, etc.)

Experience

· Demonstrated proficiency as Senior Project Assistant or equivalent experience for a minimum of six (6) months

Skills & Competencies

Required Skills

· College degree (B.S., B.A.)/University Degree for EU candidates or equivalent years of experience

· Demonstrated analytical and organization abilities coupled with good client relationship skills

· Exceptional customer service orientation

· Demonstrated proficiency with computers, especially Microsoft Office (Excel, Access, Word, PowerPoint)

· Fluency in English (will be required to write, speak and understand English to conduct day-to-day business.)

· Ability to travel for business trips (overnight business trips expected monthly)

· Ability to work independently and proactively in a small team environment with a strong attention to detail

· Comfortable working in a fast-paced, changing environment

· Flexible working style

Preferred skills:

· Understanding of pharmaceutical clinical development and/or sales & marketing

· Background in Pharmaceutical, Medical education and/or CRO

This entry was posted in AltAc, Boston, Career Development, Job Listing, Resources.