Senior Regulatory Clinical Writer

Job Title: Senior Medical Writer (Regulatory/Clinical)

Location: South Africa or Portugal--100% REMOTE

Expected Commitment

• Hours will be typically 40 hours per week, with peaks and valleys around key document milestones and submission timelines.
• Initially expected to cover upcoming document and submission needs over at least 6–12 months, with potential for extension based on program pipeline and performance.
• Approximately 2 week onboarding period, including up to 1 week to receive a client laptop and roughly 40 hours of required training.

Client Overview

Peritia is supporting a midsized, global biopharmaceutical company focused on developing and commercializing therapies in complex, highly regulated therapeutic areas. The company has an established R&D organization, active latestaged clinical programs, and a growing portfolio of regulatory submissions across multiple regions. Peritia currently supports this client with medical writing and related development functions and expects this Senior Medical Writer to strengthen an already respected Medical Writing department.

Client Business Driver

The client needs a seasoned medical writer to support ongoing clinical programs and regulatory interactions by authoring and finalizing high impact clinical and regulatory documents in alignment with ICH/CTD/GCP and internal standards.

The Work

Our professional will operate as a strategic member of the Medical Writing department, directly authoring and driving core early stage regulatory and clinical documents to completion while collaborating closely with cross-functional teams.

Typical responsibilities include:

• Writing, substantively rewriting, and editing a broad range of clinical and regulatory documents (e.g., protocols, protocol amendments, CSRs, IBs, briefing packages, CTD modules) with exceptional clarity, logical flow, and consistency for regulators, investigators, and internal stakeholders.
• Working with clinical, biostatistics, regulatory, safety, and operations colleagues to develop document strategy, key messages, and data presentations, and reconciling diverse input into unified, inspection ready documents.
• Ensuring all documents comply with ICH M4 CTD, GCP, and client SOPs/templates; proactively flagging misalignments and holding the line on scientific accuracy, transparency, and regulatory expectations.
• Managing multiple documents and zimelines in parallel, including estimating effort, sequencing work, and communicating status, risks, and dependencies in a predictable, proactive manner.
• Confidently speaking up and respectfully pushing back when requested content does not align with regulations/standards or when turnaround expectations are unrealistic, while offering alternative solutions and options.
• Applying structured QC practices (cross?checks, consistency reviews, version control) so that documents are inspection ready and aligned with departmental standards.

Professional Requirements – Technical Skills

• Minimum of 6 years of biopharma medical writing experience, with a strong track record across protocols, CSRs, IBs, briefing books, and CTD modules, including developing content from complex and evolving datasets.
• Demonstrated mastery of ICH, CTD, and GCP standards, and comfort writing for regulators, investigators, and internal stakeholders.
• Proven experience with a variety of clinical and regulatory documents (nonclinical/clinical) and familiarity with submission structures (e.g., ICH M4 CTD).
• Ability to manage multiple documents and timelines in parallel, including planning, prioritization, and coordination with cross-functional contributors.
• Evidence of structured approach to ensuring quality while preparing documents, including cross checks, internal consistency, and robust version control practices.
• Comfort working within strict templates, SOPs, and established department processes; willingness to leverage best practice/example documents rather than creating one off approaches.

Professional Requirements – Technical Skills

• Minimum of 6 years of biopharma medical writing experience, with a strong track record across protocols, CSRs, IBs, briefing books, and CTD modules, including work on complex and evolving datasets.
• Depth of experience and enthusiasm for working in early stage product development, eg., phase 1.
• Demonstrated mastery of ICH, CTD, and GCP standards, and comfort writing for regulators, investigators, and internal stakeholders.
• Proven experience with a variety of clinical and regulatory documents (nonclinical/clinical) and familiarity with submission structures (e.g., ICH M4 CTD).
• Ability to manage multiple documents and timelines in parallel, including planning, prioritization, and coordination with cross-functional contributors.
• Evidence of structured QC approach, including cross checks, internal consistency, and robust version control practices.
• Comfort working within strict templates, SOPs, and established department processes; willingness to leverage best practice/example documents rather than creating one off approaches.
• Bachelor’s degree in a relevant scientific discipline required; advanced degree preferred.

Professional Requirements – Soft Skills

• Sees themself as a strategic representative of the Medical Writing department, owning the clarity, quality, and impact of each deliverable rather than acting as a transactional document producer.
• Demonstrates integrity and ethics, ensuring accuracy, transparency, and fair representation of data in all documents and understanding that each document reflects the client’s scientific and regulatory reputation.
• Confident, calm communicator who can:
• Challenge content or approaches that do not align with regulations, internal standards, or data.
• Negotiate timelines/scope and say “no/not now” respectfully when turnarounds are unrealistic, while remaining collaborative and solution oriented.
• Thrives in matrixed, cross-functional environments; brings proactive, predictable communication about scope, expectations, status, risks, and dependencies.
• Demonstrates emotional intelligence: active listening, clarifying questions, ability to synthesize divergent feedback, and composed presence under pressure and shifting priorities.
• Strong sense of accountability—owns mistakes, corrects them quickly, follows through on commitments, and uses feedback to improve both documents and working relationships.
• Growth mindset and intellectual curiosity about the client’s products, patients, and therapeutic areas, using that context to craft purposeful, patient centric documents.