EMD Serono is currently recruiting for a Associate Director, Medical Writing to join their R&D team and serve as the medical writing lead on complex clinical programs. This position will be located in Billerica, MA and may require up to 20% both domestic and international travel.
EMD Serono is the North American biopharma brand of Merck KGaA, Darmstadt, Germany - a leading science and technology company - focused exclusively on specialty care. For more than 40 years, the brand has integrated cutting-edge science, innovative products and industry-leading patient support and access programs. EMD Serono has deep expertise in neurology, fertility and endocrinology, as well as a robust pipeline of potential therapies in oncology, immuno-oncology and immunology as R&D focus areas.
The Associate Director, Medical Writing will independently write, review and edit key documents for global regulatory submission. The Associate Director, Medical Writing interpret and explain data generated from a variety of sources. Ensure data are explained in a manner consistent with the target audience.
- Lead staff to achieve department objectives, evaluate performance, recruit, train, develop and motivate staff.
- Provide functional excellence to own team as well as colleagues across the organization.
- Independently write, review, and edit key documents for global regulatory submission; Serve as a Medical Writing Lead on more complex clinical programs and schedules and prioritizes work.
- Perform literature searches and interpret information as needed for drafting document content.
- Give direction and advanced scientific writing expertise to Clinical Operations and Program Teams.
- Maintain and ensure document writing strategy and alignment within a clinical program. Confirm completeness and clarity of information presented and challenge conclusions when necessary.
- Facilitate document review meetings and discussions.
- Determine how to allocate resources to meet timelines.
- Maintains expert knowledge of international regulations and requirements for document preparation.
- Recommend and implement process improvements.
- Advanced degree in Life Sciences (e.g., biology, chemistry, pharmaceuticals) or medical degree
- At least 10 years of Medical Writing experience
- Demonstrated people development and management skills
- Extensive experience writing all types of clinical & regulatory documents for worldwide use
- Knowledgeable in preclinical development
- Experience in leading teams to produce clinical regulatory submission documents, including CTD Module 2 summaries. Lead of at least two submissions with accountability for preparation of summary documents
- Demonstrated experience mentoring and managing the project work of other Medical Writers
- Experience in the Therapeutic area(s) assigned
- Strong understanding of drug development, study design, and biostatistics.
- Expert knowledge of international regulations, requirements, and guidelines associated with clinical regulatory document preparation and submissions. Ability to advise and guide teams regarding compliance.
- Excellent written and oral communications skills. Ability to interpret and transform data into written text for the intended audience.
- Effective influence and relationship management skills.
- Must be highly motivated, able to work independently, and willing to accept and assume a leadership role.
- Must be able to communicate effectively in large, small, and virtual group settings.
- Strong project management skills, detail oriented, and ability to organize and prioritize simultaneous projects.
- Able to work well with all levels of multicultural staff.
- Excellent Microsoft Word skills.
- Native English speaker or have proven fluency in English (oral and written) – knowledge of an additional language might be beneficial.
Equal Employment Opportunity
The Company is an Equal Employment Opportunity employer.
No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, or any other classification protected by applicable federal, state, or local law.
This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment.
Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.