Senior Medical Writer

Beigene, Ltd. Apac Emeryville , CA 94608

Posted 1 month ago

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.

  • This position is a contract to FTE. Candidates in the SF Bay Area are preferred, but remote FTE positions to be considered after initial contractor period.

Position Summary:

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, and clinical sections of INDs, NDAs, MAAs and other regulatory submission documents.

Essential Duties/ Responsibilities:

  • 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

Qualifications:

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

  • Technical expertise in Microsoft Word, Adobe Acrobat, and electronic document management systems; proficiency in Microsoft Outlook, Excel and Powerpoint

Education/Training

  • 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

Competencies:

Ethics

  • Treats people with respect; Inspires the trust of others; Works with integrity and ethically in accordance with BeiGene's Code of Business Conduct and Ethics, policies and procedures.

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 and 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 within 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, non-disqualifying physical or mental 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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Senior Medical Writer

Beigene, Ltd. Apac