A biotech and pharma career orientation — what the roles are, and where you might fit

"I want to work in biotech, but I don't know which job I'd actually do." This orientation is for you. It covers how the industry works, which roles exist, and which skills each role values — written up the way I've been learning it myself.

How to read this: facts and the skills listed for each role carry a number like [1], which matches the Sources list at the end. I'm still a student myself, so rather than give my own verdicts on each role I've gathered what published industry sources and people in the roles say. Only "What I've learned" and the four questions at the end are my own thoughts, and they're labelled.

1. How a drug reaches patients — five stages

The US FDA describes drug development in five steps [1].

1. Discovery and development — finding a candidate in the lab
2. Preclinical research — lab and animal testing for safety before anyone takes it
3. Clinical research — testing safety and effectiveness in people (Phases 1–3)
4. FDA review — regulators examine all the submitted data and decide whether to approve
5. Post-market safety monitoring — watching safety after the drug is on the market

Most roles attach to part of this flow. Read the role map below in this order and you'll see which stage each job works in. Assigning roles to stages is my own simplification to make it easier to follow; in practice many roles span several stages.

2. Where people work

• Pharma companies — in Korea, a common split is domestic companies (headquartered in Korea) and multinationals (headquartered abroad, with a Korean subsidiary). At multinationals, time differences with headquarters can mean late-evening work. Domestic companies are usually split into head office, plant and research centre, with plants and labs often outside Seoul [2].
• Biotechs — research-led companies focused on a specific technology or pipeline. Many of the deals and acquisitions in BIO:ON happen between biotechs and Big Pharma.
• CROs (contract research organisations) — run clinical trials on behalf of drug companies. CRAs work at pharma and biotech companies and at CROs [3].
• Manufacturing and quality — plants and quality teams make the medicine and confirm it meets its specifications before release [10].

3. The role map — nine core roles

R&D (discovery, preclinical)

• What it does: everything from the initial search for a molecule to treat a disease through to having a product ready to market [4].
• What it usually takes: mostly scientists — chiefly biologists and chemists — with specialist skills in toxicology, pharmacology, genetics, statistics and mathematical modelling [4].
• What sources highlight: research often means making observations over long periods, so patience and perseverance matter [16].

Clinical development / CRA (clinical)

• What it does: makes sure clinical trials run safely and in line with regulations and Good Clinical Practice (GCP), that participants' rights and safety are protected, and that trial data is reliable [3]. In Korea the legal standard is the MFDS "Good Clinical Practice for pharmaceuticals" [5]; the international standard is ICH E6 [6].
• What it usually takes: a life science, medical or healthcare degree; organisation to manage several sites and visits; attention to detail to spot data errors; communication with site staff; and often regular travel between sites [3].

Regulatory affairs (review)

• What it does: manages regulatory timelines, coordinates input from R&D, clinical, quality and manufacturing, and writes and reviews product information such as labelling and patient leaflets [7].
• What it usually takes: a life or medical science degree; clear writing; attention to detail; analysing complex information; working to deadlines; and the negotiation skills to explain decisions and influence stakeholders [7].
• In BIO:ON: the FDA starting to publish rejection letters (Issue #9); an approval despite a negative advisory vote (Issue #16).

Pharmacovigilance / drug safety (clinical to post-market)

• What it does: detects, assesses, understands and prevents side effects to weigh a medicine's risks and benefits — collecting and evaluating information from patients and healthcare professionals, assessing adverse event reports, entering them into safety databases, and writing periodic safety update reports (PSURs) [8].
• Worth knowing: safety monitoring is continuous — during trials, after licensing, and for as long as the medicine is used [8].
• What people in the role say: a Drug Safety Associate profiled by the ABPI named completing work accurately and precisely as the most important skill, because small errors can cause compliance problems. They also named working to set timeframes and instructions under pressure, and communicating well with the team [17].

QA, QC and CMC (manufacturing and quality)

• What it does: Quality control is product-oriented, testing everything from raw materials to the finished product to make sure there are no defects. Quality assurance is process-oriented, building repeatable quality into the process rather than relying only on testing at the end [9]. The legal responsibility for certifying each batch before release lies with the Qualified Person (QP), supported by QA and QC teams [10].
• What people in the role say: a clinical QA advisor profiled by the ABPI named a keen eye for detail and a good understanding of GCP and local regulations as the most important skills, adding that being disciplined, organised and open-minded helps [18].
• In BIO:ON: a recall over glass particles in vials (Issue #12); a gene therapy rejected over manufacturing, then approved (Issue #17).

Medical affairs / MSL (around launch)

• What it does: the scientific link between the company and clinicians and researchers — helping healthcare professionals understand the clinical data behind new treatments and sharing accurate, balanced, evidence-based information, usually for a region and therapeutic area [11].
• What it usually takes: a life science, medical or pharmacy degree; many roles ask for a PhD, PharmD or MD because of the depth of research and data interpretation involved [11].

Market access and pricing (approval to market)

• What it does: creates an environment where the right patients can access medicines at the right time and in the right place, working as a partner with the health system [12].
• What it usually takes: there's no single path. The ABPI's example Head of Market Access has a chemistry BSc, a medical biochemistry MSc and an MBA, and worked as a hospital scientist before moving through sales, marketing and market access in pharma [12].
• In BIO:ON: an effective oral obesity drug with slow early prescriptions (Issue #8).

Sales and marketing (on the market)

• What it does: promotes and sells the company's medicines or equipment to doctors, nurses and pharmacists, usually across a territory with a lot of travel [13].
• What it usually takes: strong product knowledge, since customers are healthcare professionals — and sales and customer service skills matter just as much, with annual targets to meet [13].
• What sources highlight: patience and self-motivation, initiative, planning, analytical and organisational skills, teamwork and networking, commercial awareness, and working well under pressure [13].

Business development

• What it does: alongside sales, marketing and market access, business development is part of a pharma company's commercial function [14]. It grows the pipeline and business through licensing in and out, partnerships, and mergers and acquisitions.
• What I've learned: writing up deal news taught me to check the guaranteed upfront payment before the headline total. The Lilly × InnoCare deal below is a good example.
• In BIO:ON: the Lilly × InnoCare deal, worth up to $3.35B but with about $100M guaranteed [15] (Issue #18).

4. Finding your direction — four questions (my own list)

These aren't official criteria — they're questions I put together while reading the role descriptions above. This isn't a test with right answers. Answer honestly and you'll narrow down where to look first.

1. What do you get absorbed in? Experiments and data → R&D, pharmacovigilance / rules and documents → RA, QA / people and persuasion → sales, MSL, BD / numbers and policy → market access
2. Where do you want to work? Lab or plant → R&D, QC / office → RA, pharmacovigilance, market access / out and about → CRA, sales, MSL
3. When do you want to see results? Years away is fine → R&D, clinical / this quarter → sales, marketing
4. Which is more comfortable: work that must be exactly right, or work where you must persuade? The first → RA, QA, pharmacovigilance / the second → BD, market access, sales

If you can't pick one, that's completely normal. Many people build experience in a first role and move sideways — like the Head of Market Access above [12].

5. Next steps

• Once you've narrowed it to two or three roles, filter the Insight archive by those roles and read recent stories. You'll see the real problems each role deals with.
• Try the same roles in the interview question bank to get a feel for what each role values.
• For which skills the industry is starting to need, see Reading biotech hiring demand in the news.

Sources

1. FDA — The Drug Development Process
2. BRIC — Surviving outside research, part 2: choosing a pharma role (Korean)
3. Prospects — Clinical research associate
4. ABPI — Research and Development
5. Korea Law Information Center — Good Clinical Practice for pharmaceuticals (Korean)
6. EMA — ICH E6 Good clinical practice
7. Prospects — Regulatory affairs officer
8. ABPI — Drug safety (Pharmacovigilance)
9. ABPI — Quality assurance, ABPI — Quality control
10. ABPI — Qualified Person (QP)
11. Prospects — Medical science liaison
12. ABPI — Head of Market Access (job case study)
13. Prospects — Medical sales representative
14. ABPI — Commercial
15. Fierce Biotech — Lilly puts up $100M, plus billions on the backend, to form 5-target deal with China's InnoCare
16. Prospects — Research scientist (life sciences)
17. ABPI — Drug Safety Associate (job case study)
18. ABPI — Clinical Quality Assurance Advisor (job case study)

The ABPI is the Association of the British Pharmaceutical Industry; Prospects is the UK's graduate careers service. Role definitions are broadly the same across countries, but details such as degree requirements and pay vary.