BeiGene Executive Director, Medical Writing in Boston, Massachusetts
BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
The Executive Director, Medical Writing is the functional head of the Global Medical Writing department and is responsible for leading all clinical regulatory medical writing activities for BeiGene that conform to domestic and/or international regulatory submission and internal document standards. Clinical regulatory documents include, but are not limited to, clinical study reports, clinical study protocols or amendments, investigator brochures, molecule-specific master ICF templates, and clinical sections of NDAs, MAAs and other regulatory submission documents. This person will be responsible for the management, planning and direction of a global team of medical writers (full-time employees and contract medical writers) in the Global Medical Writing Department.
Essential Functions of the job:
Manages all clinical regulatory writing activities outlined in the clinical development plans across BeiGene, including those required to meet Corporate Goals.
Projects Global Medical Writing department budget and resource needs
Works effectively with cross-functional groups ensure the production of high-quality, scientifically accurate documents under aggressive timelines, and ensures consistency between related documents and among medical writers
Leads cross-functional project/initiatives that impact the company on a global scale
Sets strategic vision for the department, and establishes the structure/organization for the department to successfully execute on high-quality deliverables across all programs in the company
Responsible for building and maintaining Quality Control (QC) group and Translation Group within the Global Medical Writing department
Develop and maintain medical writing processes, standards, and tools (eg, SOPs, Work Instructions, templates, style guide, etc.). Ensure clinical regulatory documents adhere to BeiGene standards and regulatory guidelines.
Manages internal staffing and performance management, including hiring, training, coaching and performance reviews.
Coordinates and manages contract medical writers and outside vendors
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 ensure the completion of high-quality documents according to tight timelines and shifting priorities/demands
Independently motivated with good problem-solving ability
Excellent interpersonal skills - must have an ability to work well with others in high-pressure situations; a team player
Strong project management and leadership skills
Experience in writing clinical protocols, protocol amendments, clinical study reports, and clinical sections of MAAs and NDAs
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 affairs (eg, FDA and ICH guidelines for various scientific documents) is required
- Oversees the entire Global Medical Writing department, including Medical Writing, QC, Translation, and Medical Writing Operations and Procedures; managing full-time employees, vendors and contractors
Computer Skills :
- Technical expertise in Microsoft Word, Adobe Acrobat, and electronic document management systems (eg Veeva Vault, Documentum, etc); proficiency in Microsoft Outlook, Excel and Powerpoint
- On occasion, as needed
At a minimum, a BA/BS degree; Master’s/PhD/PharmD in life sciences preferred.
At least 10 years of relevant industry experience in a pharmaceutical, biotech or vendor medical writing position is required. Previous managerial experience is required.
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.
We are proud to be an equal opportunity employer and we value diversity. BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.
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