- He works at the bench everyday as he used to do as a postdoc, but he enjoys not having to worry about funding and getting materials/reagents.
- Set up a LinkedIn account and realized it was about building connections. He also went to networking events and started making connections within Merrimack. So start making connections now!
- Make connections now. Do not expect to connect with people now and then ask for help or a job the following day. Having a vaccine background helped her (microbiologist by training).
- She loves the speed/demands of her job. She felt like making a change after several years and she likes doing sales, so she made the move and started thinking about previous experiences that translate to sales so that she could use them to get the job.
- After publishing in a high impact journal paper, nothing happens. What was conflicting for her was that all that work led to a high impact journal paper would not progress much beyond that. Thus, she wanted to do something about it and started a company.
- She came from a large, well-funded research group, so she says she had resources. She also did studies toward a MBA. Postdoc’d at day and hustled at night.
- Her postdoc did not prepare her for any of this! The learning curve was very steep. When starting a company you do wear 5 hats 40 hours a week. The postdoc prepared her for the science part (to sell the idea to investors), but not the business side of it. She didn’t know how to incorporate a company, how to pay her employees, how to provide them with benefits… People management is a whole different subject to deal with when setting up a company.
- Realized didn’t want to do research 3 or so years into the PhD, but he pushed through. He went to the tech transfer office and asked if they had an intern position. He now wears 3 hats at his job.
- No need to be an attorney to become a patent agent.
- Soft skills from the postdoc to apply for a job: the dealing with people, wearing twelve different hats.
- Sought out what other options are there. He found other postdocs who started a small consulting group and he joined them. That helped him stand out among a pool of job applicants when he finished his postdoc. Think outside the box!
- Took a different path: he did graduate school in molecular biology but as he progressed through grad school he realized that he didn’t want to necessarily do that.
- Skills: Learning does not often solely happen in the class room. You learn valuable skills at your work place. Rarely the person who knows more in the lab is not the PI (not in terms of the everyday requirements). It’s usually the lab manager/technician.
- He looks for people with passion and knowledge. Doesn’t care about people coming from top schools alone.
- A major skill is to ask the right questions! In his case: what does a specific sector need? How can he become an asset to their organization? Utility-centered approach. Take initiative. Know where you want to go. Be honest to yourself about not knowing. Get it out of your system.
- Much easier to teach PhDs about management than management people learning how to do science!
- Started by writing for the student magazine at Berkeley. Went to a bio-hacking talk and was intrigued by it. Moved to Boston and acquired teaching experience at Harvard, then found out about space open to do science at Somerville. Science classes open to all backgrounds (a lot of them are engineers interested in learning biotechnology!)
- Events during the weekends and a forum this Monday 9/26/16 at LabCentral.
- She is also a visiting scientist at the Broad Institute.
- In the future she wants to do the community lab (BosLabs) full-time.
- She thinks the biggest problems in the world can be addressed by science. Knew she wanted to be a geneticist when she was 13 (wanted to feed the world).
- Incredible compulsion to solve problems.
- When in Harvard she realized that many labs had a surplus of or were wasting equipment that could be used further, so she started Seeding Labs 5 years even before she officially started Seeding Labs.
- Got funding for Seeding Labs even before she started writing her thesis.
- Started doing networking events and met people that helped her learn about finances and management.
- She had to learn about 7 different languages she would not have learned when in academia to run the labs.
- You will never be prepared for the next step! You make it as you go along.
[Job Listings] Associate Project Manager opening at Bracket Global
Interested in a career in regulatory affairs? Click through to find out more!
Written by /u/LifeAfterLifeScience and copied with permission
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.
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.
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?
Client Support Specialist – Boston
- Use Sales Analysis and designated CRM to generate reports, manipulate data and effectively analyze results. Maintain appropriate notes in the designated CRM.
- Identify and maintain strategic accounts and clients to maximize effectiveness. Consistently request, receive and leverage customer referrals.
- Develop and maintain an active sales funnel of opportunities across the Promega product portfolio.
- Provide technical support by thorough knowledge of Promega’s product line and effective communication of applications related to the products.
- Support and develop strong customer and distributor relationships by acting as a liaison between the customer and various departments at Promega. Bring field issues and complex sales opportunities to the regional manager and provide necessary customer follow up. Identify both new technologies/products and “targeted” technologies/products that will benefit Promega’s business efforts.
- In cooperation with the Regional Manager, design and implement a coordinated business plan for the territory that reflects Promega’s corporate initiatives while taking into consideration the customer situation (funding, technology needs, etc)
- Work with the regional manager to develop opportunity based pricing strategies at accounts (quotes, purchasing contracts with discount schedules, freezer programs and stockroom/consignment). In conjunction with the Promega business units, organize and conduct field-marketing activities such as workshops, focus groups and beta test programs to gain customer feedback.
- Remain familiar with competitive products for the purpose of educating customers on the benefit of Promega technology. Monitor the competition and report important activites (technical developments, trends within key accounts, seminars, training sessions, etc) back to Promega.
- Drive awareness and success of the Helix program through Helix stocking and sample follow up. Host Helix relaunch parties, develop stock customization, work with the SBU to appropriately market the unit within the account.
- Work with SBU resource/Inside Sales Team/CAM to provide instrument demonstrations with the goal of moving opportunities forward.
- Discuss relevant market investment activities and playbook items for strategic territory development with the regional manager on a regular basis and enact plans to achieve goals as defined in conjunction with the regional manager. Succinctly deliver account and territory plan presentations to the sales team at regional meetings.
- Flexible in handling change, meeting a standard of excellence, persistent in pursuing goals despite obstacles and setbacks. Self-awareness of how behaviors can affect our colleagues.
- Understands and complies with ethical, legal and regulatory requirements applicable to our business.
- Attend Sales Training sessions for Miller Heiman and Spin Selling. Independently develop SPIN call plans and identify appropriate use. With manager assistance fill out and review Blue/Green sheets and sales call plans.
- Represent Promega at conferences, shows, workshops and seminars locally, regionally or nationally, as necessary. Organize and plan lectures, vendor shows, workshops and seminars in specific territory.
- Participate in organization for regional and national sales meetings including logistics, food, etc.
- BS or BA (MS, or Ph.D. preferred) degree in a life sciences related discipline.
- Technical competency to understand and to clearly discuss fundamental theory and principles of experimental design, techniques and results; to stay current in technical knowledge; to troubleshoot and to provide information back to the customer in a helpful, courteous, positive and professional manner.
- Minimum of 2 years lab experience with proven knowledge and understanding of molecular biology, cell biology and related fields.