Senior Manager/Associate Director, Medical Writing
Company: BeiGene, Ltd. APAC
Posted on: June 12, 2021
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 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
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
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
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,
The technical/scientific ability to critically analyze,
synthesize, and present complex information in well-constructed
- Working knowledge of drug/biologics development, clinical
research, study design, biostatistics, and regulatory affairs (eg,
FDA and ICH guidelines for various scientific documents) is
- Previous staff and vendor management required at the Associate
Director level; preferred for Senior Manager
- Technical expertise in Microsoft Word, Adobe Acrobat, and
electronic document management systems; proficiency in Microsoft
Outlook, Excel and Powerpoint
Treats people with respect; Inspires the trust of others; Works
with integrity and ethically; Upholds organizational values.
Prioritizes and plans work activities; Uses time efficiently.
Completes administrative tasks correctly and on time. Follows
instructions and responds to management direction.
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
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.
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
Assesses own strengths and development areas; Pursues training
and opportunities for growth; Strives to continuously build
knowledge and skills; Shares expertise with others.
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.
Demonstrates accuracy and thoroughness; Looks for ways to
improve and promote quality; Applies feedback to improve
performance; Monitors own work to ensure quality.
Synthesizes complex or diverse information; Collects and
researches data; Uses intuition and experience to complement
Identifies and resolves problems in a timely manner; Gathers and
analyzes information skillfully.
Communicates changes and progress; Completes projects on time
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
Keywords: BeiGene, Ltd. APAC, San Francisco , Senior Manager/Associate Director, Medical Writing, Other , Emeryville, California
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