Associate Director, Medical Writing
2 weeks ago
**Company Description**
Bicycle Therapeutics is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Cambridge, MA.
**Culture** is key and all Bicycle employees actively embrace and role model our company values:
- We are **Adventurous**. We believe it’s the way to deliver extraordinary results for our patients.
- We are **Dedicated to our Mission**. You can’t change the world if you don’t have determination.
- We are **One Team**. We only succeed when we work together.
Bicycle Therapeutics is seeking a motivated professional with oncology experience to fill a newly created position of Associate Director of Medical Writing. The Associate Director of Medical Writing will be responsible for the development and management of medical writing deliverables to support the clinical development portfolio. This position will report into the Director of Medical Writing and will interact closely with multiple functions, including Regulatory, Drug Safety, Clinical Operations, Biometrics, Translational, Discovery, and Preclinical groups.
- Lead, manage, and provide scientific contribution to the preparation of medical writing projects in support of the clinical development and regulatory writing portfolio, including synopses, protocols, clinical study reports, investigator brochures, development safety update reports, regulatory documents etc.
- Contribute to and refine templates for clinical trial documents, eg protocols, IBs, ICFs, CSRs, etc.
- May provide support if needed for external publications such as abstracts and manuscripts
- Provide input for medical writing processes, standards, and initiatives
- Facilitate and collaborate with internal and external stakeholders in support of clinical documentation objectives
- Ensure quality and compliance with internal and external standards
- Lead or support internal initiatives for process improvement
- May include management of external medical writing vendors
**Qualifications**
- Advanced Degree (preferred) in the Life Sciences
- Solid experience as a medical writer preparing clinical/regulatory documents in the pharmaceutical and/or biotech industry in the field of oncology
- Ability to prepare, without supervision, any type of clinical and/or regulatory document (e.g., protocol, IB, CSR, BTD, briefing documents, meeting requests/PIP/PSP) according to company guidelines and international governmental regulations and ability to present clinical data objectively in a clear, concise format in keeping with industry guidelines.
- Ability to coordinate and lead document roundtables, reviews, approvals, etc. during the authoring process, including technical troubleshooting as needed.
- Technical expertise in Microsoft Office, Adobe Acrobat, document management systems, industry standard data management systems and familiarity with SharePoint and concepts of structured content management.
- Excellent written and oral communication, and project management skills
- High attention to detail, organizational skills, and the ability to manage multiple tasks simultaneously
- Commitment to quality, ensuring that all work produced meets the highest standards of accuracy and comprehensiveness and adheres to an overall quality framework
**Desirable**:
- PhD in Life Sciences
- Previous management experience of external medical writing vendors
**Additional Information**
- State-of-the-art campus environmentwith on campus restaurant and Montessori nursery
- Flexible working environment
- Competitive reward including annual company bonus
- Employee recognition schemes
- 28 days annual leave in addition to bank holidays+ option to buy up to 5 additional days annually
- Employer contribution to pension (employee does not have to contribute)
- Life assurance cover 4x basic salary
- Private Medical Insurance, including optical and dental cover
- Enhanced parental leave policies
- Group income protection
- Employee assistance program
- Health Cash Plan
- Access to company subsidized gym membership
- Eligibility for an option grant to subscribe to shares in Bicycle Therapeutics plc.
- Cycle to work scheme
All your information will be kept confidential according to EEO guidelines.
- Bicycle Therapeutics is committed to building a diverse workforce that is representative of the communities we serve. We recognize that diverse and inclusive teams build a stronger and more innovative company. Therefore, all qualified applicants will be considered for employment, and we do not discriminate on the basis of race, religion, colour, gender, sexual orientation, age, disability status, marital status, or veteran status._
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