Running an apprentice programme for new medical writers

An apprentice programme develops new writers through structured learning, supervised project work and increasing responsibility. Running one requires a business case, a curriculum, suitable candidates, committed trainers and clear criteria for independent work.

What apprenticeship involves

AMWA's 2022 survey defined apprentice programmes as developing entry-level or junior writers over more than six months, beyond standard company training such as Good Clinical Practice. ¹ A 2019 practitioner proposal distinguished apprenticeship from periodic mentoring: occasional advice was considered insufficient, with intensive, ongoing, one-to-one workplace training needed alongside coursework. ^{2, 3, 4}

In that proposal, experienced writers reviewed and revised everything an apprentice wrote and explained their changes, assigning more complex sections as competence developed. ^{3, 5} Working with several experienced writers on different projects broadened the apprentice's knowledge, while shadowing authoring-team interactions taught when to accept an issue, challenge it, research independently or seek expert and team input. ^{3, 5} The intended endpoint was demonstrable ability to produce and manage complete documents independently to everyone's satisfaction, taking three to five years depending on the writer. ^{3, 5}

Companies must give employees time to work together, and supervisors and apprentices must invest time and energy over months or years. ^{3, 5} Regular coursework throughout the programme deepens theoretical understanding; association certificate courses and master's-level study can supplement day-to-day training but should not replace it. ^{3, 5}

Programme prevalence and design in 2022

AMWA's 2022 survey received 78 responses, primarily from people in pharmaceutical, biotechnology or device companies (44%), CROs or writing companies (23%), and writing consultancies (10%); 63% focused on regulatory writing and 82% trained or developed writers. ⁶ Company names were optional and supplied by only 38 respondents, so organisations could be represented more than once, possibly by different departments; responses were retained individually. ⁶ Of 66 respondents giving department size, 58% reported fewer than twenty writers, 14% twenty to fifty, 14% fifty-one to one hundred and 15% more than one hundred; 73% reported junior writers comprising up to half of the department. ⁶

Twenty-eight of 66 respondents (42%) reported an established apprentice or training programme, with variation by work setting, writing focus and team composition. ^{7, 8, 9}

Respondent category	Respondents	With a programme	Percentage
All respondents to the question	66	28	42.4%
Pharmaceutical, biotechnology or device company	33	8	24.2%
CRO or medical writing company	15	11	73.3%
Medical-writing consultancy	7	4	57.1%
Research or academic institution	4	1	25.0%
Medical communications company or agency	4	3	75.0%
Hospital, clinic or other healthcare facility	1	0	0%
Other work setting	2	1	50.0%
Regulatory writing	43	19	44.2%
Scientific publications, peer-reviewed	10	4	40.0%
Regulatory and communication writing	5	1	20.0%
Medical affairs	3	2	66.7%
Patient education	2	0	0%
Publications for professional audiences	1	1	100%
Other writing focus	2	1	50.0%
Fewer than 20 writers	38	8	21.1%
20–50 writers	9	4	44.4%
51–100 writers	9	8	88.9%
More than 100 writers	10	8	80.0%
Fewer than 25% junior writers	23	9	39.1%
25% to less than 50% junior writers	25	14	56.0%
50% to less than 75% junior writers	9	3	33.3%
More than 75% junior writers	9	2	22.2%

^{8, 9}

Twenty-seven of the 28 respondents with programmes answered follow-up questions. ¹⁰ Their primary and secondary goals were as follows. ^{11, 12, 13, 14}

Goal	Primary, n (%)	Secondary, n (%)
Give writers the context and skills for the current role	20 (74%)	6 (22%)
Expand the medical-writing talent pool	6 (22%)	11 (41%)
Support and champion the industry	0 (0%)	4 (15%)
Provide development opportunities requested by writers	0 (0%)	4 (15%)
Other	1 (4%)	2 (7%)

^{12, 13, 14}

Most of eight follow-up interviewees had started programmes because experienced writers were difficult to find; other aims included recruitment, retention, productivity and job satisfaction, and interviewees viewed the programmes positively. ^{11, 12}

The commonest core topics were document-specific knowledge (85%) and general writing skills (81%), with other topics including analytical skills, technical aptitude, leadership and soft skills, and drug-development knowledge. ¹⁵ Fewer than two-thirds included leadership and soft-skills training. ¹⁶ Most used team training (81%), combining shadowing or coaching (93%), presentations (85%) and self-learning (81%); other writers (85%) and managers (70%) generally delivered training. ^{15, 14} Interviewees combined theoretical and practical learning, progressing from simpler documents to complex work with feedback from clients, mentors and management. ¹⁴

Structures were time-based (26%), competency-based (37%), hybrid (33%) or other (4%); 67% of programmes lasted six months to two years, with rolling or cohort intake. ^{17, 18} Twenty-three of 27 respondents (85.2%) brought apprentices in as regular employees; the other four hired successful graduates afterwards or recommended them for a permanent role. ¹⁸

Thirty-eight of 66 respondents (58%) had no programme; 33 or 34 answered each follow-up question. ^{19, 20} Among those answering, 61% lacked training resources, 46% had few or no juniors to train, and 21% planned a programme within two years. ²⁰

Business case

Apprenticeships require substantial time and resources, and many companies need a business case before approval. ²¹ AMWA's November 2022 executives forum recommended separating quantifiable financial benefits from harder-to-measure cultural and efficiency gains. ^{22, 23}

Proposed financial benefits included the following. ²³

• Savings on recruitment: entry-level hires can be easier to recruit than senior writers requiring expensive agencies.
• Lower-cost resources: after a few months, apprentices can do simpler work and free senior writers for complex documents, potentially saving money even after allowing for additional apprentice hours.
• Avoiding substantial retraining costs for senior hires whose process knowledge or expectations differ from the company's and could cost more to address than training apprentices.
• Faster departmental growth than relying on scarce senior hires alone.
• Scalability through cross-training aligned with business needs.
• Lower apprentice attrition through strong bonds and loyalty, potentially reinforced by completion bonuses or stock options.
• Lower senior-writer attrition when training is rewarding and balanced with billable work; trainer time budgets should be included in programme costs, and reduced turnover can stabilise compensation otherwise driven upward by frequent moves.

²³

Proposed qualitative benefits followed. ²³

• Learning company processes from the start without unlearning bad habits.
• A larger, more diverse pool of well-trained writers through targeted hiring.
• Strong departmental relationships through shared work and shadowing.
• Delegation support that improves senior writers' work-life balance.
• Informal knowledge-sharing between less-experienced and senior writers.
• Improved morale through lower apprentice attrition.
• Better clinical research through well-trained writers.
• Succession planning and sustainability.

²³

Specific internal business drivers and quantified short- and long-term advantages help make a complete case. ²³

Structure and duration

Programme goals should be defined first. ²⁴ The design questions include the following. ^{24, 25, 26}

• Is the goal rapid writing output, or developing and retaining writers with soft skills and broader context?
• Should the programme be time-based, competency-based or hybrid?
• How many apprentices should join at once?
• How will a small company apply the approach?
• Should fellowships involve an academic institution?
• Will candidates with atypical education or skills be included, and how will training adapt?
• How long should a programme cycle last?

^{25, 26}

The 2022 forum recommended six design choices. ²⁶

1. Use a hybrid approach: define competencies from current and future business needs, identify individual gaps and set a timeframe for demonstrating competence.
2. Bring in cohorts of at least two, depending on company size, business need and available senior trainers.
3. Adapt programmes to small companies as well as large ones.
4. Use an academic institution where a relationship exists.
5. Consider candidates outside the usual profile for their diversity of thought and experience, with a needs assessment and tailored training.
6. Set a cycle of six months to two years according to programme, individual and company needs.

²⁶

Its example placed lower-complexity documents in year one and higher-complexity work in year two and beyond, aiming ultimately at independent management of a project from start to finish. ²⁶

Core curriculum

The curriculum should combine technical writing knowledge with broader soft skills; content within each domain can vary with programme deployment. ²⁷ Four core domains were recommended. ²⁷

• Medical-writing skills and knowledge: Drug development, documents across the development lifecycle and their relationships, especially for regulatory writers; basic statistics, lean authoring, good documentation principles, technology tools, document preparation, review and quality checks. Document- and therapeutic-area-specific training can extend this foundation.
• Time and project management: Project planning, execution, timeline development and management, negotiation, decision-making, time management, prioritisation and risk mitigation and management.
• Communication: Professional communication, establishing and aligning cross-functional expectations, leading meetings and influencing without authority.
• Teamwork: Leadership as a process driver, difficult personalities, interpersonal relationships, conflict resolution, problem-solving, team lifecycle and contingency planning. Training should start early because these skills need time and confidence to develop.

^{28, 29, 30, 31}

Learning methods and supervision

Entry assessment of baseline knowledge, skills and background should guide individual training, with learning starting as early as possible. ³² Self-presentation alone is insufficient: candidates may overestimate how previous journal or grant writing prepares them for regulatory or complex communication projects. ³²

Recommended learning methods include the following. ³²

1. Complete the AMWA Essential Skills programme.
2. Complete mock writing tasks, which can also assess baseline ability.
3. Implement simple quality-check findings.
4. Review finished documents and team or QC comments on drafts to learn document expectations, style and processes.
5. Contribute to live projects with a senior writer, writing sections or performing quality checks.
6. Progress gradually to complete low-complexity documents.
7. Attend project meetings, including kickoff, data interpretation, comment resolution and lessons learned, even outside assigned teams; take minutes for active participation.
8. Join meeting debriefs to learn how to read the room and understand strategy.

³²

Soft-skills methods include the following. ³²

• Relevant AMWA courses and workshops.
• Presentations to colleagues, such as sharing conference learning or explaining a project timeline, to practise clear and effective oral communication.
• Shadowing senior writers' project management and problem-solving.

³²

Internal or external subject experts can deliver formal training, with senior-writer buddies providing ongoing guidance and mentoring; trainers may need specific preparation, and the responsibility should appear in their job descriptions. ³²

Recruitment and selection

Candidate quality can affect programme success. ^{33, 34} Recruitment can use academic relationships, graduate sessions or webinars explaining the profession and programme, normal job platforms, and LinkedIn or other social media with a short initial questionnaire. ³⁵ A life-sciences background through education or work is a useful starting profile, alongside enthusiasm for writing and communication, scientific curiosity and social skills for project management. ³⁵ Cover letters and previous publications can show writing interest and aptitude. ^{35, 36}

Selection begins with CV grammar, style, formatting and technical skills. ³⁶ Where HR policy permits, a timed writing assessment before interview may help, using the same assessment and an objective, uniform scoring method for everyone. ³⁶ A comprehensive interview completes the profile, combining role-specific, personality, behavioural and experience questions. ^{36, 37} Suggested interview questions cover the following. ³⁷

• Reasons for applying and choosing the company, showing preparation and motivation.
• Understanding of medical writing.
• Behavioural questions in a panel, such as challenges overcome and how.

³⁷

Apprentice titles can include associate, fellow or trainee, subject to company HR policy. ³⁷ Multiple tracks may include an accelerated route for people with advanced degrees or some writing experience and a standard or longer route for less-experienced entrants. ³⁴

Progress and programme evaluation

Evaluators, criteria and completion timelines should be agreed at the outset, using a competency model such as DIA's to frame goals; valued intangibles such as soft skills should be explicit and assessed throughout. ³⁸ Periodic feedback should be two-way: managers and senior writers assess apprentice competence, and apprentices assess programme effectiveness. ³² Completion or promotion can be defined as independently driving at least one predefined document type, including independent development of new content. ³² Expected performance at completion depends on programme duration and the goals agreed by apprentice and mentor. ³⁸

Programme administrators can track whether graduates obtain writing roles internally or elsewhere and progress to independent work on increasingly complex documents and with more complex teams. ³⁸ Feedback from colleagues at several points can identify gaps requiring more training, another learning method or a different track. ³⁸ Apprentices should be asked at planned intervals whether they have adequate learning and leadership opportunities, where gaps remain and whether the programme prepares them for the next career stage. ³⁸ Retention incentives may mitigate the risk that a trained graduate leaves. ³⁸ Success ultimately means an independent writer who continues to grow, supported by an adaptable programme. ³⁸

Framework development in 2023

A standard framework was considered useful by 63% of survey respondents with programmes and 82% without them. ^{18, 20} Following the 2022 forum, AMWA's Executives Advisory Council planned a framework covering recommended content, structure, duration and completion competencies, to help companies create or benchmark programmes. ^{39, 40} An Apprenticeship Framework Working Group had been established, and development remained ongoing when the survey results appeared in 2023. ^{41, 16}