Department: Medical Writing
Reports To: Head of Medical Writing
•At a minimum, a BA/BS degree; PhD/PharmD in life sciences preferred
• At least 3-5 years of relevant industry experience as a regulatory medical writer
The Senior Medical Writer is responsible for writing, editing, and formatting clinical regulatory documents that conform to domestic and/or international regulatory submission and internal document standards, while meeting project timelines. Clinical regulatory documents include, but are not limited to, study reports, clinical study protocols or amendments, investigator brochures, regulatory briefing documents, and clinical sections of INDs, NDAs, MAAs and other regulatory submission documents. The Senior Medical Writer may assist in the preparation of manuscripts, abstracts, posters, and presentations, as well as participate in the document QC process, as needed.
Essential Functions of the job:
Works effectively with cross-functional groups to produce high-quality, scientifically accurate documents under strict timelines, and ensures consistency between related documents
• Responsible for ensuring that assigned documents undergo a quality check before approval, and that documents are routed correctly during review and approval cycles
• Manage timelines and communicate with team members to maintain awareness of expectations, milestones, and deliverables
• Review and edit documents, including those authored by others both internally and externally
• Collaborate within the medical writing group to develop and maintain medical writing processes, standards, and tools (eg, SOPs, Work Instructions, templates, style guide, etc.)
• Ensure clinical documents adhere to BeiGene standards and regulatory guidelines
• Coordinate and manage contract medical writers as needed
Knowledge and Skills:
• Demonstrated ability to communicate and write English clearly, concisely, and effectively
• Well-organized: ability to prioritize tasks, work simultaneously on multiple projects, and complete high-quality documents according to tight timelines and shifting priorities/demands
• Independently motivated with good problem-solving ability
• Excellent interpersonal skills; a team player
• Ability to coordinate and manage communications to enable timely reviews from other authors and reviewers and to function as a collaborative team member
• Strong project management skills
• Recent and significant experience in writing of regulatory documents such as clinical study reports, protocols, and protocol amendments
• Keen understanding of the key requirements for regulatory submissions as stipulated in FDA and ICH guidelines
• Experience in writing clinical sections of INDs, MAAs, and NDAs is a plus
• The technical/scientific ability to critically analyze, synthesize, and present complex information in well-constructed documents
• Working knowledge of drug/biologics development, clinical research, study design, biostatistics, the regulatory environment, and medical terminology preferred
• Ability to comply with company and/or industry style guides and templates
• Excellent attention to detail related to consistency, grammar, syntax, and scientific accuracy
Ethics – Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
Planning/Organizing – Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.
Communication – Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.
Teamwork – Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone’s efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others.
Adaptability – Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.
Technical Skills – Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.
Dependability – Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
Quality – Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
Analytical – Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.
Problem Solving – Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.
Project Management – Communicates changes and progress; Completes projects on time and budget.
• Technical expertise in Microsoft Word, Adobe Acrobat, and electronic document management systems; proficiency in Microsoft Outlook, Excel and PowerPoint