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Senior Manager/Associate Director, Medical Writing

Company: BeiGene, Ltd. APAC
Location: Emeryville
Posted on: June 12, 2021

Job Description:

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.

General Description:

The Senior Manager/Associate Director, Medical Writing is responsible for leading 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, regulatory briefing documents, and clinical sections of INDs, NDAs, BLAs, MAAs and other regulatory submission documents. This person will be responsible for the management, planning and direction of a team of full-time employees and/or contractors, consisting of medical writers, translators, and/or QC Specialists

Essential Functions of the job:

  • Manages clinical regulatory writing activities outlined in the clinical development plans across BeiGene, including those required to meet Corporate Goals.

  • 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, translators, and/or QC Specialists

  • 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 contractors and outside vendors

  • May assist in projections of Medical Writing department budget and resource needs

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 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 INDs, MAAs, BLAs, 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, and regulatory affairs (eg, FDA and ICH guidelines for various scientific documents) is required

Supervisory Responsibilities:

  • Previous staff and vendor management required at the Associate Director level; preferred for Senior Manager

Education Required:

  • At a minimum, a BA/BS degree; Master's/PhD/PharmD in life sciences preferred.

  • Eight years of relevant industry experience at the associate director level, 5+ at the senior manager level, in a pharmaceutical, biotech or vendor medical writing position is required.

Computer Skills:

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

Travel:

  • On occasion, as needed

Competencies:

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, 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.

Keywords: BeiGene, Ltd. APAC, San Francisco , Senior Manager/Associate Director, Medical Writing, Other , Emeryville, California

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